A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dosage-Escalation, Single Centre Study to Evaluate the Safety and Immunogenicity of an Adjuvanted SARS-CoV-2 Sclamp Protein Subunit Vaccine in Healthy Adults Aged 18 to 55 Years Old and Healthy Older Adults, Aged 56 Years and Over
Phase: PHASE1
Conditions: SARS-CoV2, Covid19
Sponsor: The University of Queensland

7013800 SARS-CoV-2 Sclamp Vaccine Suspension for Intramuscular Injection FIH  
The University of Queensland 
02-NOV-2020 
 
 
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SYNEOS HEALTH PROTOCOL# 7013800 
Protocol number: UQ-1-SARS-CoV-2-Sclamp 
 
A PHASE 1 RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
DOSAGE -ESCALATION, SINGLE CENTRE STUDY TO EVALUATE THE 
SAFETY AND IMMUNOGENICITY OF AN ADJUVANTED SARS-CoV-2 SCLAMP 
PROTEIN SUBUNIT VACCINE IN HEALTHY ADULTS, AGED 18 TO 55 YEARS 
AND HEALTHY OLDER ADULTS, AGED 56 YEARS AND OVER 
Short Title: 
A SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF 
ADJUVANTED SARS-CoV-2 SCLAMP PROTEIN SUBUNIT VACCINE IN 
HEALTHY ADULTS AND HEALTHY OLDER ADULTS 
 

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Sponsor: 
University of Queensland 
School of Chemistry & Molecular Biosciences 
Building 68, St Lucia QLD 4072 
Australia 
Tel.: +61 7 3365 4622 
 
 
Contract Research 
Organization: 
 
 
 
Protocol Version: 
v2.2 
 
 
Date of Protocol: 
02-Nov-2020 
 
CONFIDENTIAL 
 
This document is strictly confidential. It was developed for University of Queensland by Syneos Health and must 
not be disclosed to a third party, with the exception of regulatory agencies and study audit personnel without the 
consent of either Syneos Health or the Sponsor. This document is copyrighted in favour of Syneos Health and 
cannot be reproduced, modified, or adapted, in part or in total, without prior written approval by Syneos Health.  

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Protocol Historical File 
Version 
number 
Brief description/summary of changes 
Date 
Final 
Version submitted to the HREC. 
22-MAY-2020 
Amendment 1 Updated version submitted to the HREC 
03-JUL-2020 
Amendment 2 Section 1.3 Australian Redcross Lifeblood laboratory details 
added. 
Section 5.2.1 and Section 11.2 Additional clarification 
around immunological assays. 
Section 4 Clarification to Schedule of Events, footnote 13 use 
of subject diary, and Footnote 17 Blood sample collection. 
Section 9.9.1 Inclusion of samples storage and retention 
period.  
Section 9.9 Inclusion of an additional blood sample collected 
at Day 57 to allow adequate serum collection for IgG and 
virus neutralisation.  
Section 9.10.6.6. Revised macroscopic examination to 
microscopic which was previously written in error. 
Section 9.10.7 Added clarifying text around the use of the 
subject eDiary and review of the ediary at site. 
Revisions to minor inconsistencies in document related to the  
hyperlinks within the protocol, along with the Table of 
Contents. 
Section 9.15.1 Additional information included to clarify the 
definition of a solicited event and an unsolicited adverse 
event 
Section 9.15.2 Additional information included to clarify the 
definition of solicited events as Adverse Events 
Section 9.15.2.2 Deletion of Table 6 COVID Symptoms 
Prompt. 
28-JUL-2020 
Version 2.0 
Major Protocol amendment to include healthy older 
adults aged 56 years and over 
Section 2 Synopsis of Protocol 
Study Title amended to reflect inclusion of healthy older 
adult population 
Study Design amended to reflect study to be conducted in 2 
parts where Part 1 will include a young healthy adult 
population aged ≥ 18 - ≤ 55 years and Part 2 will include an 
older healthy adult population aged 56 years and over. Part 1 
will be a single and multiple ascending dose, 4-arm, parallel 
study initiated before commencement of Part 2 so that safety 
can be assessed in the young adult population prior to 
exposure of the older adult population.  Part 2 will be a 
19-AUG- 2020 

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multiple ascending dose, 3-arm, parallel study, with 3 new 
Cohorts 4, 5 & 6.  
A total of 216 subjects now planned to be recruited. 
A paper diary will be available for those subject who do not 
have a device to support an eDiary application. 
Study Vaccine and Placebo Dosage Form amended to reflect 
actions taken to maintain blind. 
Inclusion Criteria: amended to reflect criteria applicable to 
healthy adult and older healthy adult population so Part 1 
Inclusion criteria and Part 2 Inclusion criteria. 
Exclusion Criteria: amended to reflect criteria applicable to 
healthy adult and older healthy adult population so Part 1 
Exclusion criteria and Part 2 Exclusion criteria.  
Statistical Analysis: included an interim analysis for safety 
and immunogenicity up to day 57 for older healthy adult 
cohort to be an addendum to the CSR. 
Safety Review Committee: clarified that vaccination of older 
healthy adults (Part 2) will commence only when the safety 
evaluation for Part 1 Vaccination Dose 1 is completed. 
Section 5  
Section 5.2 amended to reflect study to be conducted in 2 
parts where Part 1 will include a young healthy adult 
population aged ≥ 18 - ≤ 55 years and Part 2 will include an 
older healthy adult population aged 56 years and over. Part 1 
will be initiated before commencement of Part 2 so that 
safety can be assessed in the young adult population prior to 
exposure of the older adult population.   
Section 6 Study design amended to reflect study to be 
conducted in 2 parts where Part 1 will include a young 
healthy adult population aged ≥ 18 - ≤ 55 years and Part 2 
will include an older healthy adult population aged 56 years 
and over. Part 1 will be a single and multiple ascending dose, 
4-arm, parallel study initiated before commencement of Part 
2 so that safety can be assessed in the young adult population 
prior to exposure of the older adult population.  Part 2 will be 
a multiple ascending dose, 3-arm, parallel study, with 3 new 
Cohorts 4, 5 & 6. An additional 96 subjects will be recruited, 
with approximately equal subjects aged ≥ 56 - ≤ 65 years of 
age and ≥ 66 years of age and older. 
Updated Figure 1 to show revised study design. 
Section 6.1 Updated to clarify that vaccination for Cohorts 
4,5,6 will only commence once the SRC have completed their 
review of the aggregated safety and tolerability data for 
Cohorts 1,2,3. 

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Section 7.1 Clarified the SRC responsibility for study 
progression from Part 1 to Part 2. 
Section 8.1 Updated to provide rationale for inclusion of 
older adults in study population. 
Section 8.2 Sample size updated to include numbers of 
subjects and their treatment assignment in the new Cohorts 4,  
and 6. 
Section 8.3 Inclusion Criteria- included new Part 2 Inclusion 
criteria for healthy older adult cohort. 
Section 8.4 Exclusion Criteria -included new Part 2 
Exclusion criteria for healthy older adult cohort. 
Section 9.3 included blinding status up until Day 57 for Part 
2 subjects. 
Section 9.4 included Part 2 Cohorts 4,5 & 6 for allocation of 
subjects to treatment and method of assignment to treatment 
groups . 
Section 9.5 updated blinding details for study vaccine and 
administration. 
Section 9.5 included cohorts 4, 5 & 6 in study medication 
treatment groups. 
Section 9.6 updated storage conditions for prepared vaccine. 
Section 9.8.3 inserted missing word “excluded” which was an 
oversight from previous versions. 
Section 9.9 Inserted new table for summary of samples to be 
collected for Part 2 subjects (fewer samples). 
Section 9.10.7 inserted option for Paper diary (Diary) for 
subject self-reporting. 
Section 9.10.8 Included  Diary along with eDiary for 
injection site examination. 
Section 9.15.2 included paper diary card (Diary) 
Section 11 Included new interim analysis for Day 57 for Part 
2 subjects which will be an addendum to the CSR. 
Section 11.4.3 updated definition for Immunogenicity 
population for the Day 57 analyses to include Part 1 and Part 
2. 
Section 12 Included new interim analysis for Day 57 for Part 
2 subjects which will be an addendum to the CSR . 

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v2.2 
General : minor editorial change - standardised document to 
“subjects” rather than mix of subjects and partipants 
throughout. 
Version 2.1 
Inclusion of exploratory endpoint to determine if an 
immune response to the molecular clamp of the Sclamp 
antigen can trigger a false positive for HIV testing 
Objectives: Inclusion of objective to assess whether SARS-
CoV-2 Sclamp vaccination can cause false positive in 
subsequent HIV testing  
 
Endpoints: Evaluation of participant blood samples by a 
range of HIV point of care and rapid diagnostic tests to 
determine if the post vaccination response results in a false 
positive outcome, and if so, the rate of false positive 
detection. 
 
Section 11.2 update to include assessment of HIV diagnostics 
07-SEP-2020 
Version 2.2 
Inclusion of additional visit to inform the participants of 
vaccine induced HIV diagnostic interference and provide 
written and verbal information around this result 
 
Amendment of exploratory endpoint to determine 
probability and duration of the preliminary positive 
results following some point of care and rapid HIV tests. 
 
Section 4, Schedule of Events: update to include additional 
vist at Day 120 for subset of participants from Cohorts 1-2.  
Section 9.2 Clinical visits and follow up (additional visits 
added) 
Section 9.9, Sample Collection and Processing: addition of 
immunology samples will be collected at Day 120, 209 and 
394 to further test probability and duration of the preliminary 
positive results following some point of care and rapid HIV 
tests. 
02-NOV-2020 

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Signature Page 
 
Sponsor 
University of Queensland 
School of Chemistry & Molecular Biosciences 
Building 68, St Lucia QLD 4072 
Australia 
Tel.: +61 7 3365 4622 
 
 
 
University of Queensland Representative: 
Associate Professor Keith Chappell 
Chief Investigator 
 
 
 
________________________________________  
______________________ 
Associate Professor Keith Chappell  
 
 
 
 
 Date 
 
 
 
6-11-2020

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1. 
Facilities and Responsible Staff 
1.1 
Clinical Research Organization (CRO) 
INC Research LLC, a Syneos Health company (“Syneos Health”) 
3201 Beechleaf Court, Suite 600 
Raleigh NC 27604, USA 
Tel.: +1 91 9876 9300 
1.2 
Clinical Research  
This study will be conducted at the following facility: 
Q-Pharm Pty Ltd 
Level 5, Clive Berghofer Cancer Research Centre (CBCRC) 
300c Herston Road 
Herston QLD 4006, Australia 
Tel.: +61 8 8222 2763 
1.3 
Biomedical Laboratory Facilities 
Biomedical laboratory testing will be performed by the following laboratories: 
SydPath 
Level 6 Xavier Building 
St. Vincent’s Hospital 
Victoria Street 
Darlinghurst NSW 2010, Australia 
Tel.: +61 2 8382 9119 
University of Queensland 
QBI Building 79 
St. Lucia QLD 4072, Australia 
Tel. +61 7 3365 1111 
TetraQ 
Level 7, Block 6 
Royal Brisbane and Women’s Hospital 
Herston Road 
Herston QLD 4029, Australia 
Tel.: +61 7 3365 5115 
The Peter Doherty Institute for Infection and Immunity 
University of Melbourne 
79 Elizabeth Street 
Melbourne VIC 3000, Australia 
Tel.: +61 3 9035 3555 
Pathology Queensland 
Level 3, Block 7 
Royal Brisbane and Women’s Hospital 
Herston Road 

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Herston QLD 4029, Australia 
Tel.: +61 7 3365 5115 
Australian Red Cross Lifeblood 
44 Musk Avenue, Kelvin Grove 4059, QLD, Australia 
If another biomedical laboratory is used, this will be documented and annexed to the 
protocol. 
1.4 
Clinical Pharmacology and Regulatory Affairs  
Syneos Health 
2500, rue Einstein 
Québec (Québec), Canada, G1P 0A2 
Tel.: 1-418-527-4000 
Stéphane Lamouche, Ph.D. 
Director, Regulatory & Scientific Affairs 
 
Protocol writing: 
Matthew Bendikov, Ph.D. 
Clinical Research Scientist  
1.5 
Medical Monitor 
Dr. Jon Rankin, MB BS Grad. Dip. PH SCHP JD(Hons) 
Syneos Health 
159 Port Road, Hindmarsh, 
Adelaide SA 5007 Australia 
Mobile: +61 499 222 117 
 
 

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Table of Contents 
1. 
FACILITIES AND RESPONSIBLE STAFF ........................................................................... 9 
1.1 
CLINICAL RESEARCH ORGANIZATION (CRO) .............................................................................................. 9 
1.2 
CLINICAL RESEARCH ................................................................................................................................. 9 
1.3 
BIOMEDICAL LABORATORY FACILITIES ....................................................................................................... 9 
1.4 
CLINICAL PHARMACOLOGY AND REGULATORY AFFAIRS .......................................................................... 10 
1.5 
MEDICAL MONITOR ................................................................................................................................. 10 
2. 
SYNOPSIS OF PROTOCOL .................................................................................................. 13 
3. 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .......................................... 29 
4. 
SCHEDULE OF EVENTS ....................................................................................................... 32 
5. 
INTRODUCTION .................................................................................................................... 36 
5.1 
BACKGROUND INFORMATION..................................................................................................................... 36 
5.2 
RATIONALE FOR STUDY DESIGN ................................................................................................................ 37 
5.2.1 
Analytes to be Measured ................................................................................... 38 
5.2.2 
Choice of the Dose ............................................................................................ 38 
5.3 
STUDY OBJECTIVES .................................................................................................................................... 40 
5.4 
STUDY ENDPOINTS ..................................................................................................................................... 40 
6. 
STUDY DESIGN ...................................................................................................................... 42 
6.1 
STUDY PROGRESSION AND EVALUATIONS ................................................................................................. 45 
6.2 
STARTING DOSE ......................................................................................................................................... 45 
6.3 
DOSE ESCALATION SCHEME....................................................................................................................... 45 
7. 
DOSE ESCALATION CRITERIA ......................................................................................... 45 
7.1 
DATA REVIEW BY THE SAFETY REVIEW COMMITTEE ................................................................................ 45 
7.2 
DOSE HALTING RULES ............................................................................................................................... 46 
8. 
STUDY POPULATION ........................................................................................................... 47 
8.1 
RATIONALE FOR THE STUDY POPULATION ................................................................................................. 47 
8.2 
SAMPLE SIZE .............................................................................................................................................. 48 
8.3 
INCLUSION CRITERIA ................................................................................................................................. 48 
8.4 
EXCLUSION CRITERIA ................................................................................................................................ 51 
9. 
CLINICAL PROCEDURES .................................................................................................... 55 
9.1 
SCREENING PROCEDURES ........................................................................................................................... 55 
9.2 
CLINICAL VISITS AND FOLLOW-UP ............................................................................................................ 56 
IN ADDITION, SUBJECTS WILL BE ASKED TO RETURN TO THE CLINIC AT APPROXIMATELY 6 AND 12 MONTHS POST 
SECOND DOSE (APPROXIMATELY DAYS 209 AND 394) FOR A SAFETY FOLLOW-UP AND BLOOD DRAWS FOR 
ASSESSMENT OF THE DURATION OF THE IMMUNE RESPONSE TO THE VACCINE. ...................................................... 56 
9.3 
RANDOMISATION AND BLINDING ............................................................................................................... 56 
9.4 
ALLOCATION OF SUBJECTS TO TREATMENT ............................................................................................... 57 
9.5 
STUDY MEDICATION .................................................................................................................................. 57 
9.6 
TREATMENT SUPPLIES AND ACCOUNTABILITY .......................................................................................... 58 
9.7 
STUDY TREATMENT ADMINISTRATION ...................................................................................................... 59 
9.8 
STUDY RESTRICTIONS ................................................................................................................................ 59 
9.8.1 
Food and Fluids................................................................................................ 59 
9.8.2 
Tobacco, Alcohol, and Illicit Drugs ................................................................. 60 
9.8.3 
Prior and Concomitant Medications ................................................................ 60 
9.8.4 
Posture and Physical Activity ........................................................................... 60 
9.9 
SAMPLE COLLECTION AND PROCESSING .................................................................................................... 60 
9.9.1 SAMPLES STORAGE ....................................................................................................................................... 61 
9.10 
SUBJECT MONITORING ............................................................................................................................... 62 
9.10.1 
Vital Signs ......................................................................................................... 63 
9.10.2 
ECG .................................................................................................................. 63 
9.10.3 
Physical Examination ....................................................................................... 63 
9.10.4 
Drug and Alcohol Screen ................................................................................. 63 

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9.10.5 
Pregnancy Test ................................................................................................. 63 
9.10.6 
Laboratory Assessments ................................................................................... 64 
9.10.7 
Subject Self-Reporting ...................................................................................... 65 
9.10.8 
Injection Site Examination ................................................................................ 65 
9.11 
STUDY EXIT PROCEDURES ......................................................................................................................... 66 
9.12 
DATA COLLECTION AND EVALUATION ...................................................................................................... 66 
9.13 
SUBJECT WITHDRAWAL AND REPLACEMENT ............................................................................................. 66 
9.14 
EARLY TERMINATION VISIT ....................................................................................................................... 67 
9.15 
ADVERSE EVENTS ...................................................................................................................................... 67 
9.15.1 
Definition of Adverse Events ............................................................................ 67 
9.15.2 
Recording of Adverse Events ............................................................................ 68 
9.15.3 
Serious Adverse Events ..................................................................................... 72 
9.15.4 
Suspected Unexpected Serious Adverse Reactions ........................................... 74 
9.16 
PREGNANCY ............................................................................................................................................... 74 
9.17 
REPORTABLE DISEASE ............................................................................................................................... 75 
9.18 
PREMATURE TERMINATION OF THE STUDY ................................................................................................ 75 
10. 
ANALYTICAL METHODOLOGY ....................................................................................... 75 
11. 
STATISTICAL ANALYSES ................................................................................................... 76 
11.1 
SAFETY MEASUREMENTS ........................................................................................................................... 77 
11.2 
IMMUNOGENICITY ...................................................................................................................................... 79 
11.3 
SUCCESS CRITERIA..................................................................................................................................... 79 
11.4 
ANALYSIS POPULATIONS............................................................................................................................ 79 
11.4.1 
Intent-to-Treat (ITT) Population (Full Analysis Set, FAS) ............................... 79 
11.4.2 
Safety Population .............................................................................................. 80 
11.4.3 
Immunogenicity Population up to Day 57 ........................................................ 80 
11.4.4 
Full Immunogenicity Population ...................................................................... 80 
11.5 
IMMUNOGENICITY ANALYSIS ..................................................................................................................... 80 
12. 
FINAL REPORT ...................................................................................................................... 81 
13. 
REGULATORY CONSIDERATIONS AND QUALITY ASSURANCE ............................ 82 
13.1 
INDEPENDENT ETHICS COMMITTEE APPROVAL OF PROTOCOL AND OTHER STUDY DOCUMENTS .............. 82 
13.2 
COMPLIANCE.............................................................................................................................................. 82 
13.3 
QUALITY ASSURANCE PROGRAM ............................................................................................................... 83 
13.4 
AUDITS, INSPECTIONS AND MONITORING ................................................................................................... 83 
14. 
CONFIDENTIALITY AND RETENTION OF STUDY RECORDS .................................. 83 
15. 
REFERENCES ......................................................................................................................... 84 
APPENDIX I CHECKLIST FOR MEDICAL HISTORY FOLLOW-UP FOR PERSONS WHO 
MEET THE PROTOCOL DEFINED COVID-19 CASE DEFINITION. ..................................... 85 
 
 

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2. 
Synopsis of Protocol 
Project No.: 
Syneos number: 7013800 
Protocol number: UQ-1-SARS-CoV-2-Sclamp 
Study Title: 
A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dosage-
Escalation, Single Centre Study to Evaluate the Safety and 
Immunogenicity of an Adjuvanted SARS-CoV-2 Sclamp Protein Subunit 
Vaccine in Healthy Adults, Aged 18 to 55 years and Healthy Older Adults, 
Aged 56 years and over. 
Study Vaccine: 
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) Sclamp 
protein subunit vaccine (with squalene based adjuvant, MF59C.1) 
Study Phase and Type: 
Phase 1 – First-In-Human (FIH), Interventional  
Objectives: 
Primary Safety Objective: 
• 
To assess the safety and tolerability of SARS-CoV-2 Sclamp 
vaccine compared to placebo.  
Primary Immunogenicity Objective: 
• 
To assess the total serum antibody and neutralising antibody 
(NAb) immune responses elicited by SARS-CoV-2 Sclamp 
vaccine compared to placebo at Day 29 (28 days after first dose) 
and Day 57 (28 days after second dose). 
Secondary Immunogenicity Objective: 
• 
To compare the total serum antibody and NAb immune responses 
at Day 1 (baseline), Day 15, Day 29 (28 days after the first dose), 
Day 43, Day 57 (28 days after the second dose), Day 209 
(6 months after the second dose), and Day 394 (12 months after 
the second dose). 
Exploratory Immunogenicity Objectives: 
• 
To follow subjects for 12 months following study treatment 
administration to record infections with SARS-CoV-2 and 
evaluate the frequency and severity of all cases of laboratory 
confirmed COVID-19 disease. 
• 
To conduct a detailed analysis of humoral and cellular immune 
responses elicited to Sclamp antigen upon vaccination compared 
to placebo and comparisons between dosing levels and across 
time course post-vaccination. 
• 
Assess whether SARS-CoV-2 Sclamp vaccination can cause false 
positives in subsequent HIV testing 
Endpoints: 
Primary Safety Endpoints: 
• 
Frequency, duration, and intensity of solicited local adverse 
events (AEs), including pain, redness, and induration for 7 days 
following each study treatment (for Days 1-3, Days 4-7 and 
Days 1--7).  
• 
Frequency, duration, and intensity of solicited systemic adverse 
events (AEs), including fever, nausea, chills, diarrhoea, headache, 

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fatigue, and myalgia for 7 days following each study treatment 
(for Days 1-3, Days 4-7 and Days 1-7). 
• 
Frequency, duration, intensity, duration, and relatedness of 
unsolicited AEs through to Day 57. Frequency of Serious 
Adverse Events (SAEs), Medically-Attended Adverse Events 
(MAAEs), and any AEs leading to study withdrawal (including 
decision by the Principal Investigator (PI) not to proceed with the 
second dose) at any time during study through to Day 394. 
Frequency and intensity of unsolicited AEs through to Days 57, 
209, and 394 
Primary Immunogenicity Endpoints: 
• 
Geometric mean titre (GMT) of the serum antibody response to 
the Sclamp antigen compared to placebo by antigen specific 
ELISA at Day 29 (28 days after first dose) and Day 57 (28 days 
after second dose). 
• 
GMT of the serum NAb titres to SARS-CoV-2 virus compared to 
placebo by microneutralisation (MN) assay at Day 29 (28 days 
after first dose) and Day 57 (28 days after second dose). 
Secondary Immunogenicity Endpoints:  
• 
Proportion of subjects with ≥4 fold increase in titre above 
baseline by ELISA at Days 15, 29, 43, 57, 209, and 394 post-
vaccination compared to placebo. 
• 
Proportion of subjects with ≥4 fold increase in titre above 
baseline by MN assay at Days 15, 29, 43, 57, 209, and 394 post-
first study treatment administration compared to placebo. 
• 
GMT of the serum antibody response to the Sclamp antigen 
compared to placebo by antigen specific ELISA at Days 1, 15, 29 
(28 days after first dose), and Days 43, 57 (28 days after second 
dose) and Days 209 and 394 (6 and 12 months post-second dose 
respectively). 
• 
GMT of the serum NAb titres to SARS-CoV-2 virus compared to 
by MN assay at Days 1, 15, 29 (28 days after first dose), and 
Days 43, 57 (28 days after second dose) and Days 209, 394. 
Exploratory Immunogenicity Endpoints: 
• 
Proportion of subjects experiencing laboratory confirmed SARS-
CoV-2 infection and/or severity graded COVID-19 disease 
between Days 57 and 394 compared to placebo. 
• 
Proportion of subjects with titres of ≥1:80 and ≥ 1:160 by MN 
assay at Days 1, 15, 29, 43, 57, 209, and 394 compared to 
placebo.  
• 
Proportion of subjects with ≥10 fold increase in titre above 
baseline by MN assay at Days 1, 15, 29, 43, 57, 209, and 394 
compared to placebo. 
• 
Proportion of subjects showing an increase in antigen specific 
CD4+ T-cells at Days 15, 29, 36, 43, and 57 compared to 
pre-vaccination for vaccine antigen dose versus placebo. 

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• 
Proportion of subjects showing an increase in antigen specific 
CD8+ T-cell at Days 15, 29, 36, 43, and 57 compared to 
pre-vaccination for vaccine antigen dose versus placebo. 
• 
Evaluation of antibody dependent cellular cytotoxicity (ADCC) at 
Days 1, 15, 29, 43, 57, 209, and 394 compared to placebo for 
vaccine antigen dose versus placebo. 
• 
Evaluation of domain specificity of the elicited humoral immune 
response, specifically the proportion of antibodies elicited to the 
Receptor Binding Domain (RBD), N-Terminal Domain (NTD), 
and clamp trimerization domain by a custom Luminex assay 
and/or ELISA for vaccine antigen dose versus placebo on Days 1, 
15, 29, 43, 57, 209, and 394. 
• 
Evaluation of antigen specific humoral immune responses 
including isotypes IgM, IgA, IgE, and subtypes IgG1, IgG2, 
IgG3, and IgG4 at Days 1, 15, 29, 43, 57, 209, and 394 compared 
to placebo by a custom Luminex assay. 
• 
Evaluation of participant blood samples by a range of HIV point 
of care and rapid diagnostic tests to determine if the post 
vaccination response results in a false positive outcome, and if so, 
the rate of false positive detection and duration of the response. 
Study Design: 
This will be a single centre, Phase 1, FIH, randomised, double-blind, 
placebo controlled, single and multiple ascending dose, 4-arm, parallel 
study.  
The study will be conducted in two parts: Part 1 will include a young 
healthy adult population aged ≥ 18 - ≤ 55 years and Part 2 will include an 
older healthy adult population aged 56 years and over. Part 1 will be a 
single and multiple ascending dose, 4-arm, parallel study initiated before 
commencement of Part 2 so that safety can be assessed in the young adult 
population prior to exposure of the older adult population.  Part 2 will be a 
multiple ascending dose, 3-arm, parallel study.  
This study will consist of 6 cohorts (2 cohort each of a lower, intermediate, 
and higher dose, examining both a single and two dose administration 
regimen). Cohorts 1,2 and 3 will include subjects aged  ≥ 18 - ≤ 55 years 
of age and cohorts 4,5 and 6 will include subjects aged 56 years and older. 
Cohorts 4, 5 and 6 will include an approximately equal number of subjects 
aged ≥ 56 - ≤ 65 years of age,  and  ≥ 66 years of age and older.  
Cohort 1 will include 32 subjects (8 receiving placebo and 24 subjects 
receiving a lower dose of SARS-CoV-2 Sclamp vaccine administered in a 
two dose regimen 28 days apart). Cohort 2 will include 32 subjects (8 
receiving placebo and 24 subjects receiving an intermediate dose of 
SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days 
apart). Cohort 3 will include 56 subjects (8 subjects receiving placebo, 24 
subjects receiving a higher dose of SARS-CoV-2 Sclamp vaccine 
administered in a two dose regimen 28 days apart, and 24 subjects 
receiving a single dose of the high-dose of SARS-CoV-2 Sclamp vaccine 
dosed once followed by placebo 28 days later). Cohort 4 will include 32 
subjects (8 receiving placebo and 24 subjects receiving a lower dose of 
SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days 
apart). Cohort 5 will include 32 subjects (8 receiving placebo and 24 
subjects receiving an intermediate dose of SARS-CoV-2 Sclamp vaccine 
administered in a two dose regimen 28 days apart). Cohort 6 will include 
32 subjects (8 subjects receiving placebo, 24 subjects receiving a higher 

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dose of SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 
28 days apart). 
A total of 216 subjects are planned to be included in the study. 
Since this is a FIH study with a novel vaccine antigen, a conservative 
approach to vaccine dosing will be adopted to ensure safety of study 
subjects. Sentinels will be used for each of cohorts 1, 2 and 3 such that two 
randomly selected subjects will receive either the first dose of SARS-CoV-
2 Sclamp vaccine or placebo on Day 1 (and again on Day 29 for the 
second dose). After at least 24 hours from the time of administration of the 
first dose a review of the immediate post-vaccination safety data will be 
conducted by the Safety Review Committee (SRC) in accordance with the 
study protocol. Should there be no safety concerns the remaining subjects 
in the cohort will be dosed. The step-wise dose escalation study design is 
an additional precautionary measure, where the lower dose cohort will 
complete their first vaccination, and the cumulative safety data from the 
first 7 days will be evaluated by the SRC prior to initiating vaccination 
with sentinels of the intermediate dose of vaccine; same repeated at next 
(higher) dose level. After the first vaccination dose has been administered 
to Cohorts 1, 2 and 3 and the aggregated safety data reviewed, vaccination 
will be initiated for Cohorts 4, 5 and 6. 
Subjects will also have access to an electronic diary to capture solicited 
and unsolicited AEs and a memory prompt for symptoms of COVID-19. A 
paper diary will be available for those subjects in Cohorts 4, 5 and 6 who 
do not have a device that can support the eDiary application.  Subjects will 
be instructed to advise the clinical site if they have been diagnosed with 
COVID-19, shown symptoms of COVID-19, or returned from overseas in 
the interim period. Where an acute respiratory illness, or any other relevant 
signs or symptoms that are clinically suspect for COVID-19, is identified 
and confirmed by nasal/oropharyngeal swab and SARS-CoV-2 specific 
polymerase chain reaction (PCR), subjects will be advised to contact the 
clinical site immediately. Subjects will be given an information sheet that 
defines the symptoms for COVID-19 at the time of receipt of their first 
study vaccination. 
Subjects: 
Approximately 216 healthy adult males or non-pregnant females, ≥18 
years of age, non-smokers and social smokers (defined as the equivalent of 
fewer than 10 cigarettes per week), with BMI >18.0 and <34.0 kg/m2, will 
be recruited for participation in this study. Subjects will be randomly 
divided into6 cohorts stratified by age group. Each cohort will receive two 
single doses at 28 days apart (with a treatment assignment of active + 
active, active + placebo, or placebo + placebo). 
Screening Procedures: 
After an individual has consented to participate in the study and informed 
consent is signed, that individual will be assigned a unique screening 
number. Screening procedures will include, documenting demographic 
data, medical and medication histories (such as history of diabetes 
mellitus, hypertension, and asthma, excluding childhood asthma) complete 
physical examination, body measurements, ECG (12-lead), vital signs 
including tympanic temperature (TT), blood pressure and oxygen 
saturation (SpO2), haematology, random blood sugar (non-fasting), 
biochemistry, coagulation (PT, APTT and fibrinogen), human 
immunodeficiency virus (HIV), hepatitis B (HBsAg) and hepatitis C 
(HCV) tests, SARS-CoV-2 test (nasal/oropharyngeal swab and reverse 
transcription polymerase chain reaction [RT-PCR], and serum antibodies 
by ELISA), urinalysis, serum pregnancy test, alcohol breath test, urine 
drug screen, and an FSH test (if required) to confirm post-menopausal 
status. 

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Safety Measurements 
Safety will be assessed by measuring the frequency and intensity of local 
and systemic solicited AEs, unsolicited AEs, SAEs, and safety laboratory 
data for all subjects. 
Solicited AEs will be assessed by the proportion (%) of subjects with 
solicited local and systemic AEs up to 7 days after each vaccination by 
symptom and intensity for the periods: Days 1-3, Days 4-7, and Days 1--7. 
Unsolicited AEs will be assessed by the proportion (%) of subjects with 
any unsolicited AEs within 28 days after each treatment dose or until 
Day 57. 
Proportion (%) of subjects with SAEs, medically attended AEs (MAAEs), 
and any AEs leading to study withdrawal or decision by the Principal 
Investigator (PI) not to proceed with the second dose will be collected 
from study start until study exit. A MAAE is defined as any AE that 
requires an unscheduled/unplanned (at the time of visit 1) medical 
appointment with a primary care physician, or any other health 
professional. 
Solicited local and systemic AEs will be collected using electronic diary 
cards for 7 days following each vaccination dose. Subjects will be 
requested to take an oral temperature reading for the first 7 days after 
vaccination and to record other systemic and local AEs that may develop, 
as well as medication that they have received. Solicited local AEs include 
pain, redness, and induration at the injection site. Solicited systemic AEs 
include raised oral temperature (≥38 °C), chills, nausea, headache, fatigue, 
diarrhoea, and myalgia. All other AEs will be collected at specified safety 
follow-up visits (Days 8, 15, 36, 43, 57, 209, and 394).  
Clinical Visits: 
Each subject will come for a visit to the clinical facility on Days 1 and 29 
to receive their assigned treatment administration. After each dose subjects 
will remain in the clinic for at least 2 hours under observation for 
monitoring of immediate hypersensitivity reactions such as anaphylaxis. 
Samples for immunological and safety laboratory assessments will be 
taken pre-dose during subject screening and on Day 1 and Day 29. 
Subjects will return on Days 2 and 30, and on Days 8 and 36 for a 24-hour 
and 7-day post-dose safety assessment. 
Subjects will also return on Days 8, 29, 36, and 57 where they will be 
assessed for safety, including clinical laboratory safety assessments and 
immunological response. Subjects will return on Days 15 and 43 where 
they will be assessed for immunological response only.  
A time tolerance of ±1 day for visits from Days 8 and 15, ±2 days for visits 
from Day 29, 30, 36, 43 and 57, and ±5 days for visits from Day 209 
onwards, will be allowable. 
Follow-Up Visits:  
Subjects will also be asked to return at 6 and 12 months after their last 
dose (Days 209 and 394) for a follow-up safety and immunology 
assessment to evaluate the duration of the immune response to the vaccine. 
Subjects will be asked to return for an adhoc visit in early November 
where they will be informed of findings related to vaccine related HIV 
diagnostic interference. Subjects will receive written and verbal 
information on the potential for vaccination to elicit a reactive HIV results 
on some diagnostics and assured that this result does NOT indicate a HIV 
positive result. 

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A subset of subjects will also be asked to return at 3 months after their last 
dose (Day 120) for additional immunology assessment to evaluate the 
duration of HIV diagnostic cross-reactivity. 
Study Vaccine and Placebo 
Dosage Form 
Drug product (DP) will be provided as separate single-use vials containing 
each, the SARS-CoV-2 Sclamp antigen (CSIRO Manufacturing, Clayton 
VIC 3168, Australia). PBS for DP dilution will be provided as separate 
single-use vials (Sypharma Pty Ltd, 27 Healy Rd Dandenong, VIC 3175). 
Squalene adjuvant material, MF59C.1, will be supplied in pre-filled 
syringes each containing a total volume of 0.25 mL. (Seqirus). DP and 
adjuvant will be mixed at the clinical site, and 0.5 mL of the vaccine 
suspension will be drawn into a syringe for IM injection as the final 
investigational medicinal product (IMP). 
Placebo will be provided in a single-use vial containing sterile saline for 
injection (Pfizer, Mulgrave VIC 3170). 0.5 mL of the placebo will be 
drawn into a syringe for injection.  
All vaccine and placebo materials will be received and handled while 
observing aseptic techniques. After preparation, the vaccination dose will 
be transported in a blinding bag placed in a box, and blinded dosers will be 
used to preserve the blinding, as physical masking of the syringe to 
preserve the blind is not possible.  
Study Vaccine or Placebo 
Administration: 
Subjects will receive two single IM doses of the following study 
treatments at 28 days apart as follows:  
IM administration (to the deltoid region of the subjects nondominant arm 
or deltoid area of other arm should a tattoo be present) of SARS-CoV-2 
Sclamp adjuvanted vaccine, or placebo, administered on Days 1 and 29, of 
one of the following treatments:  
Treatment A (Test 1): SARS-CoV-2 Sclamp vaccine 1 x 5 mcg in 0.5 mL 
suspension, administered as two separate doses at least 28 days apart 
Treatment B (Test 2): SARS-CoV-2 Sclamp vaccine 1 x 15 mcg in 0.5 mL 
suspension, administered as two separate doses  at least 28 days apart 
Treatment C (Test 3): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL 
suspension, administered as two separate doses at least 28 days apart  
Treatment D (Test 4): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL 
suspension, administered as the first dose, followed by placebo as the 
second dose at least 28 days apart 
Placebo: 0.5 mL solution (sterile saline for injection) 
Inclusion Criteria: 
Part 1  
Subjects must meet all of the following criteria to be included in the study: 
1. Healthy male or non-pregnant female, ≥18 and ≤55 years of age, 
with BMI >18 and <34.0 kg/m2 and body weight ≥50.0 kg for 
males and ≥45.0 kg for females.  
2. Healthy as defined by: 
a. 
The absence of clinically significant illness and surgery 
within 28 days prior to dosing. Subjects displaying signs 
or symptoms of an acute and/or febrile illness within 24 
hours pre-dose (with at least 3 symptom-free pre-dose 
days required) will be carefully evaluated for upcoming 

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illness/disease. Inclusion pre-dosing is at the discretion 
of the Investigator, and the subject may have their 
scheduled dosing postponed until the condition resolves. 
b. The absence of clinically significant history of 
neurological, endocrine, cardiovascular, respiratory, 
haematological, immunological, psychiatric, 
gastrointestinal, renal, hepatic, and metabolic disease. 
3. Non-smokers or social smokers (defined as the equivalent of 
fewer than 10 cigarettes per week). Ex-heavy smokers (heavy 
smoking defined as the equivalent of 25 or more cigarettes per 
day) may be admitted if they have quit,or reduced their cigarette 
intake to the defined level of social smoking, for a period of at 
least 12 months. 
4. Women of childbearing potential (WOCBP) or men whose sexual 
partners are WOCBP must be able and willing to use at least 
2 highly effective methods of contraception  commencing at 
enrolment, during the study and for 3 months after last treatment 
administration. A female subject is considered to be a WOCBP 
following menarche and until she is in a post-menopausal state for 
12 consecutive months (without an alternative medical cause) or 
otherwise permanently sterile (for which acceptable methods 
include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy). A follicle-stimulating hormone (FSH) test may 
be used to confirm post-menopausal state. Examples of 
acceptable methods of contraceptive methods (for female 
subjects) to be used throughout the study include: 
a. 
Simultaneous use of hormonal contraceptives, started at 
least 28 days prior to first study treatment administration 
and must agree to use the same hormonal contraceptive 
throughout the study, and condom for the male partner; 
b. Simultaneous use of intra-uterine contraceptive device, 
placed at least 28 days prior to first study treatment 
administration, and condom for the male partner; 
c. 
Simultaneous use of diaphragm or cervical cap and male 
condom for the male partner, started at least 28 days 
prior to first study treatment administration; 
d. Sterile male partner (vasectomized since at least 
6 months prior to first study treatment administration); 
e. 
True abstinence, defined as no sexual intercourse with a 
male partner, (for heterosexual couples) for at least 
28 days prior to first study treatment administration and 
for at least the duration of the study. Periodic abstinence 
and withdrawal are not acceptable methods. 
5. WOCBP must have a negative urine pregnancy test prior to 
receiving each dose. 
6. Male subjects (including men who have had a vasectomy) with a 
pregnant partner, a female partner not of childbearing potential, or 
a same sex partner, must agree to use a condom from the first 
study treatment administration until at least 90 days after the last 
study treatment administration. 

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7. Male subjects must be willing not to donate sperm until 90 days 
following the last study treatment administration. 
8. Must be able to attend all visits for the duration of the study and 
to comply with all study procedures according to the study 
schedule. 
9. Capable of, and have given, written informed consent. 
Part 2  
Subjects must meet all of the following criteria to be included in the study: 
1. Healthy male or non-pregnant female  ≥ 56  years of age, with 
BMI >18 and <34.0 kg/m2 and body weight ≥50.0 kg for males 
and ≥45.0 kg for females.  
2. Healthy as defined by: 
a. 
The absence of clinically significant illness and 
surgery within 28 days prior to dosing. Subjects 
displaying signs or symptoms of an acute 
and/or febrile illness within 24 hours pre-dose 
(with at least 3 symptom-free pre-dose days 
required) will be carefully evaluated for 
upcoming illness/disease. Inclusion pre-dosing 
is at the discretion of the Investigator, and the 
subject may have their scheduled dosing 
postponed until the condition resolves. 
b. The absence of clinically significant history of  
a pre-existing medical condition that is not 
stable (neurological, endocrine, cardiovascular, 
respiratory, haematological, immunological, 
psychiatric, gastrointestinal, renal, hepatic, and 
metabolic disease). A stable medical condition 
is defined as disease not requiring significant 
change in therapy or hospitalization for 
worsening disease during the 3 months before 
enrolment. 
3. Non-smokers or social smokers (defined as the equivalent of 
fewer than 10 cigarettes per week). Ex-heavy smokers (heavy 
smoking defined as the equivalent of 25 or more cigarettes per 
day) may be admitted if they have quit,or reduced their cigarette 
intake to the defined level of social smoking, for a period of at 
least 12 months. 
4. Women of childbearing potential (WOCBP) or men whose sexual 
partners are WOCBP must be able and willing to use at least 
2 highly effective methods of contraception  commencing at 
enrolment, during the study and for 3 months after last treatment 
administration. A female subject is considered to be a WOCBP 
following menarche and until she is in a post-menopausal state for 
12 consecutive months (without an alternative medical cause) or 
otherwise permanently sterile (for which acceptable methods 
include hysterectomy, bilateral salpingectomy, and bilateral 
oophorectomy). A follicle-stimulating hormone (FSH) test may 
be used to confirm post-menopausal state. Examples of 
acceptable methods of contraceptive methods (for female 
subjects) to be used throughout the study include: 

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a. 
Simultaneous use of hormonal contraceptives, started at 
least 28 days prior to first study treatment administration 
and must agree to use the same hormonal contraceptive 
throughout the study, and condom for the male partner; 
b. Simultaneous use of intra-uterine contraceptive device, 
placed at least 28 days prior to first study treatment 
administration, and condom for the male partner; 
c. 
Simultaneous use of diaphragm or cervical cap and male 
condom for the male partner, started at least 28 days 
prior to first study treatment administration; 
d. Sterile male partner (vasectomized since at least 
6 months prior to first study treatment administration); 
e. 
True abstinence, defined as no sexual intercourse with a 
male partner, (for heterosexual couples) for at least 
28 days prior to first study treatment administration and 
for at least the duration of the study. Periodic abstinence 
and withdrawal are not acceptable methods. 
5. WOCBP must have a negative urine pregnancy test prior to 
receiving each dose. 
6. Male subjects (including men who have had a vasectomy) with a 
pregnant partner, a female partner not of childbearing potential, or 
a same sex partner, must agree to use a condom from the first 
study treatment administration until at least 90 days after the last 
study treatment administration. 
7. Male subjects must be willing not to donate sperm until 90 days 
following the last study treatment administration. 
8. Must be able to attend all visits for the duration of the study and 
to comply with all study procedures according to the study 
schedule. 
9. Capable of, and have given, written informed consent.  
Exclusion Criteria: 
Part 1:  
Subjects to whom any of the following applies will be excluded from the 
study: 
1. Any clinically significant abnormality or vital sign abnormality at 
physical examination (including baseline high blood pressure 
[140/90] after 3 repeated measurements or high random blood 
sugar [non-fasting]), clinically significant abnormal laboratory 
test results or positive test for HIV, hepatitis B, or hepatitis C 
found during medical screening. 
2. Any acute or chronic ongoing illness which, in the judgement of 
the investigator, may preclude the subject’s participation.  
3. Any subject that has an active COVID-19 infection (positive 
COVID-19 test: nasal/oropharyngeal swab and/or positive serum 
antibody response) at screening, or Day 1, or has been in close 
contact with someone who has an active COVID-19 infection, or 
has recovered from a previous COVID-19, SARS-CoV--1, or 
MERS infection. 

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4. Positive pregnancy, urine drug screen, or alcohol breath test at 
screening. 
5. Known history of allergic reactions or hypersensitivity to 
vaccines, or to any excipient in the formulation (including the 
adjuvant, MF59C.1). 
6. Presence of a known, or suspected, impairment of the immune 
system including, but not limited to, HIV, autoimmune disorders, 
immunosuppressant therapy, and diabetes mellitus. 
7. History of a known, or suspected, respiratory system disorder 
including, but not limited to, cystic fibrosis, reactive airway 
disease, emphysema, chronic bronchitis, chronic obstructive 
pulmonary disease (COPD), or asthma, excluding childhood 
asthma. 
8. History of significant alcohol abuse within 12 months year prior 
to screening. 
9. Positive test for drugs of abuse (such as 
marijuana/tetrahydrocannabinol [THC] products, amphetamine, 
methamphetamine, methadone, barbiturates, benzodiazepines, 
cocaine, opiates, methylenedioxymethamphetamine [MDMA], or 
phencyclidine [PCP]) at screening, prior to dosing, or a history of 
drug abuse within 12 months prior to screening. 
10. Participation in a clinical research study involving the 
administration of an investigational, or marketed, drug or device 
within 30 days prior to receiving the first treatment 
administration, or administration of a biological product in the 
context of a clinical research study within 90 days prior to the 
first dosing, or concomitant participation in an investigational 
study involving no drug, vaccine, or device administration, or 
intent to participate in another clinical study at any time during 
the conduct of the study. 
11. Use of medications for the timeframes specified below, with the 
exception of hormonal contraceptives and medications exempted 
by the Investigator on a case-by-case basis because they are 
judged to interfere with subject safety e.g., topical drug products 
without significant systemic absorption are permissible:  
a. 
Prescription medication within 14 days prior to the first 
dosing; 
b. Any medication, or treatments, that may affect the 
immune system such as allergy injections, 
immunoglobulin, interferon, immunomodulators, 
cytotoxic drugs, or other drugs known to be frequently 
associated with significant major organ toxicity within 
90 days prior to enrolment; 
c. 
Any registered vaccine administered within 30 days 
prior to enrolment in the study, or who plan to receive 
any non-study vaccines within 28 days of the second 
dose of the study vaccine 
d. Any other investigational coronavirus vaccine i.e. 
SARS--CoV-1, SARS--CoV-2, MERS etc. at any time 
prior to, or during, the study.  

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e. 
Over-the-counter products within 7 days prior to the first 
dosing, with the exception of the occasional use of 
paracetamol (up to 2 g daily) and standard dose vitamins. 
12. Donation of plasma within 7 days prior to dosing. Donation or 
loss of blood (excluding volume drawn at screening) of 50 mL to 
499 mL of blood within 30 days, or more than 499 mL within 56 
days prior to the first dosing. 
13. Receipt of blood products within 2 months prior to the first study 
treatment administration (Day 1), or planned receipt of blood 
products during the study period. 
14. Breast-feeding subject, or subject who plans to breastfeed from 
the time of first dose through 60 days after last study treatment 
administration. 
15. Presence of tattoos, scarring, skin discoloration, or any other skin 
disturbances at the injection site which, in the opinion of the 
Investigator, may inhibit the ability to effectively perform an 
injection site assessment. 
16. Employee or immediate relative of an employee of the clinical 
site, any of its affiliates or partners, or Syneos Health. 
17. Any reason which, in the opinion of the Investigator, would 
interfere with the primary study objectives or prevent the subject 
from participating in the study. 
Part 2  
Subjects to whom any of the following applies will be excluded from the 
study: 
1. Any clinically significant abnormality or vital sign abnormality at 
physical examination, or uncontrolled hyertension in adults aged  
≥ 56 years and older ), or high random blood sugar [non-fasting]), 
clinically significant abnormal laboratory test results or positive 
test for HIV, hepatitis B, or hepatitis C found during medical 
screening. 
2. Any acute or chronic ongoing illness which, in the judgement of 
the investigator, may preclude the subject’s participation.  
3. Any subject that has an active COVID-19 infection (positive 
COVID-19 test: nasal/oropharyngeal swab and/or positive serum 
antibody response) at screening, or Day 1, or has been in close 
contact with someone who has an active COVID-19 infection, or 
has recovered from a previous COVID-19, SARS-CoV--1, or 
MERS infection. 
4. Positive pregnancy, urine drug screen, or alcohol breath test at 
screening. 
5. Known history of allergic reactions or hypersensitivity to 
vaccines, or to any excipient in the formulation (including the 
adjuvant, MF59C.1). 
6. Presence of a known, or suspected, impairment of the immune 
system including, but not limited to, HIV, autoimmune disorders, 
immunosuppressant therapy, and diabetes mellitus. 

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7. History of a known, or suspected, or currently unstable medical 
condition that may expose the subject to an increased risk for 
severe SARS-CoV-2 disease, such as a respiratory system 
disorder including, but not limited to, cystic fibrosis, reactive 
airway disease, emphysema, chronic bronchitis, chronic 
obstructive pulmonary disease (COPD), or asthma, excluding 
childhood asthma, uncontrolled hypertension, ischemic or 
structural heart disease, chronic kidney disease,  chronic liver 
disease, endocrine disorder and neurological illness. 
8. History of significant alcohol abuse within 12 months year prior 
to screening. 
9. Positive test for drugs of abuse (such as 
marijuana/tetrahydrocannabinol [THC] products, amphetamine, 
methamphetamine, methadone, barbiturates, benzodiazepines, 
cocaine, opiates, methylenedioxymethamphetamine [MDMA], or 
phencyclidine [PCP]) at screening, prior to dosing, or a history of 
drug abuse within 12 months prior to screening. 
10. Participation in a clinical research study involving the 
administration of an investigational, or marketed, drug or device 
within 30 days prior to receiving the first treatment 
administration, or administration of a biological product in the 
context of a clinical research study within 90 days prior to the 
first dosing, or concomitant participation in an investigational 
study involving no drug, vaccine, or device administration, or 
intent to participate in another clinical study at any time during 
the conduct of the study. 
11. Use of medications for the timeframes specified below, with the 
exception of hormonal contraceptives and medications exempted 
by the Investigator on a case-by-case basis because they are 
judged to interfere with subject safety e.g., topical drug products 
without significant systemic absorption are permissible:  
a. 
Prescription medication within 14 days prior to the first 
dosing that in the opinion of the Investigator could 
impact the subjects safe participation in the study; 
b. Any medication, or treatments, that may affect the 
immune system such as allergy injections, 
immunoglobulin, interferon, immunomodulators, 
cytotoxic drugs, or other drugs known to be frequently 
associated with significant major organ toxicity within 
90 days prior to enrolment; 
c. 
Any registered vaccine administered within 30 days 
prior to enrolment in the study, or who plan to receive 
any non-study vaccines within 28 days of the second 
dose of the study vaccine 
d. Any other investigational coronavirus vaccine i.e. 
SARS--CoV-1, SARS--CoV-2, MERS etc. at any time 
prior to, or during, the study.  
e. 
Over-the-counter products within 7 days prior to the first 
dosing that in the opinion of the investigator could 
impact the subjects safe participation in the study. 

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Paracetamol, (up to 2 g daily) and standard dose 
vitamins will be permitted. 
12. Donation of plasma within 7 days prior to dosing. Donation or 
loss of blood (excluding volume drawn at screening) of 50 mL to 
499 mL of blood within 30 days, or more than 499 mL within 56 
days prior to the first dosing. 
13. Receipt of blood products within 2 months prior to the first study 
treatment administration (Day 1), or planned receipt of blood 
products during the study period. 
14. Breast-feeding subject, or subject who plans to breastfeed from 
the time of first dose through 60 days after last study treatment 
administration. 
15. Presence of tattoos, scarring, skin discoloration, or any other skin 
disturbances at the injection site which, in the opinion of the 
Investigator, may inhibit the ability to effectively perform an 
injection site assessment.  
16. Employee or immediate relative of an employee of the clinical 
site, any of its affiliates or partners, or Syneos Health. 
17. Any reason which, in the opinion of the Investigator, would 
interfere with the primary study objectives or prevent the subject 
from participating in the study. 
18. Permanent resident in an aged care facility (nursing or aged care 
home). 
Study Restrictions: 
Subjects will be allowed to engage in normal activity.  
Sample Collection for 
Analysis: 
Over the course of the study, a blood sample will be collected at each visit 
(total of no more than 36 blood samples from each subject) for screening, 
safety laboratory and immunological assessments. Sample volume 
collected will vary between 15 mL and a maximum of 73 mL with 
individual samples collected into multiple tubes to facilitate disparate 
immunological tests.  
A total of 8 blood samples will be collected for safety laboratory 
assessments from each subject, one sample at screening, pre-dose (within 
30 minutes pre-dose), and 1, 7, and 14 days post dose for each dose 
(Days 1, 2, 8, 29, 30, 36). Each sample will consist of 15 mL of whole 
blood.  
PD samples collected for immunogenicity assessments will include 4 mL 
for T-cell analysis, 10 mL for IgG ELISA, virus neutralisation, and ADCC 
analysis, and 20 mL to isolate PBMCs for cryopreservation.  
The total volume of blood including that collected for eligibility screening 
and safety purposes should not exceed 500 mL for the whole study, with 
up to 400 mL collected at visits between Day 1 and Day 57±2, and up to 
100 mL collected at the Day 209±5 and 394±5 visits.  
Subject Monitoring: 
ECG and vital signs: Day of vaccination (pre dose) and approximately 
24 hours post dose.  
Urine pregnancy test, alcohol breath test, and urine drug screen: before 
each dosing. 

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Clinical laboratory safety parameters, including haematology, coagulation 
and serum chemistry: before each dosing and Days 1, 2, 8, 29, 30, 36 and 
57.  
Safety parameters, including laboratory  parameters and vital signs    will 
be assessed by the PI or delegate, using the clinical site’s criteria for 
acceptance ranges as  guidelines in making the medical assessment. 
Abnormal laboratory blood and urinalysis results will be graded as mild, 
moderate or severe. 
Safety measurements which in the opinion of the investigator are deemed 
clinically significant will be recorded as adverse events. 
Injection site evaluation: before each dosing and approximately 
30 minutes, 24 hours (Days 2 and 30), and until 7 days post injection 
(Days 8 and 36). Subjects will be provided instructions on how to self-
assess at home daily. 
Medical surveillance: Subjects will be monitored throughout the study by 
the clinical staff for adverse events, as described above. The Principal 
Investigator (PI) will be on site for study treatment administration and at 
least 30 minutes post-dose, and will be available on call for the remainder 
of the study. 
Should a subject be diagnosed with laboratory confirmed COVID-19 
disease at any time throughout the duration of the study, they will be 
instructed to contact the study site. COVID-19 infection will be a SAE, 
and follow-up by a trained healthcare provider will be required to 
document the severity of the disease. 
Study Exit Procedures 
(Day 394): 
AE monitoring. A blood sample will be taken to assess the magnitude and 
duration of the immune response to the vaccine. 
Analytical Methods for 
Humoral and Cellular 
Immune Response: 
Analysis of the humoral response for SARS-CoV-2 at pre-dose, Days 15, 
29, 43, 57, 209, and 394; (i) ELISA for antigen specific immune response 
(ii) virus  based neutralisation assay (PBNA), and (iii) antibody dependent 
cellular cytotoxicity (ADCC) that will include assessment of potential 
correlates of protection 
The induction of antigen specific T-cells will be assessed through the 
stimulation of peripheral blood mononuclear cells (PBMCs) with a vaccine 
specific peptide library and analysed by multi-colour flow cytometry 
following surface staining for CD3, CD4, CD8, and intracellular cytokine 
staining for IFN-γ, TNF-α, IL-2, IL-4, IL-13, IL-17a, CD107a, and 
Granzyme B. 
Statistical Analyses: 
A complete description of the statistical analyses and methods to be 
performed will be presented in a statistical analysis plan (SAP) to be 
finalised prior to database lock. This document will provide further details 
regarding the definition of analysis variables and analysis methodology to 
address all study objectives. The SAP will serve as a complement to the 
protocol and supersedes it in case of differences. 
An interim analysis will be performed once all Part 1 subjects (Cohorts  1, 
2 and 3) have completed Day 29, and immunology assays for all samples 
up to Day 29 are completed. A brief study status report will be prepared 
and will discuss the safety, tolerability and immunogenicity data following 
a single vaccination dose. A further interim analysis will be performed 
once all Part 1 subjects (Cohorts 1, 2 and 3) have completed Day 57, and 
immunology assays for all samples up to Day 57 are completed. The Final 
CSR will be written following the completion of the Active Study Period 

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Evaluation Visit (Day 57) and will discuss the safety, tolerability and 
immunogenicity data collected during the Active Study Period. 
The immunology assessments to be included for the Active Study Period 
in the CSR are the GMT of the serum antibody response (ELISA) to the 
Sclamp antigen and the serum NAb response by MN assay at Days 29 and 
57 i.e. 28 days after the first and second dose respectively, the proportion 
of subjects with a ≥4 fold increase in titre above baseline by ELISA at 
Days 15, 29, 43 and 57 compared to placebo, and the proportion of 
subjects with a ≥4 fold increase in titre above baseline by MN assay at 
Days 15, 29, 43 and 57 compared to placebo.  
Statistical assessments will include comparisons between the four 
treatment groups (A-D), as appropriate to each cohort and comparison of 
each treatment to the placebo group.  
An interim analysis will be performed once all Part 2 subjects (cohorts 4,5 
and 6) have completed Day 57, and immunology assays for all samples up 
to Day 57 are completed. An addendum to the Final CSR will be written 
following the completion of the Active Study Period Evaluation Visit (Day 
57) for Part 2 subjects and will discuss the safety, tolerability and 
immunogenicity data collected during the Active Study Period.  
Addenda to the final study report will be prepared following the 6 month 
follow-up visit (Day 209) and the 12 month follow-up visit (Day 394) for 
Part 1 and Part 2 subjects. These addenda will discuss the safety and 
immunogenicity data collected at the 6 month follow-up visit (the period 
between the Active Study Period and the 6 month follow-up visit) and the 
12 month follow-up visit (the period between the 6 month follow-up visit 
and the 12 month follow-up visit). 
Demographic parameters will be summarized descriptively. TEAEs and 
injection site reaction data will be tabulated by study treatment for all 
subjects who were dosed (Safety Population). Safety and tolerability data 
will be reported using descriptive statistics. Changes from baseline values 
in vital signs and clinical laboratory parameters will be evaluated and 
tabulated by study treatment. No inferential statistical analysis of safety 
data is planned. 
Descriptive statistics will be used to present all safety and immunogenicity 
results; number of observations (n), mean, standard deviation (SD), 
median, minimum (min), maximum (max), (including geometric mean, 
and CV%  for immunogenicity data) for continuous data. For categorical 
variables, data will be tabulated with the number and proportion of 
subjects for each category by treatment group. 
Binary data i.e. percentages of subjects with seroconversion will be 
tabulated for each group using unadjusted estimates and will be reported 
together with two-sided exact 95% confidence intervals (CIs), 
Clopper-Pearson. No multiplicity adjustment to the CI levels will be 
implemented. 
The difference between the proportions of treatment groups will be 
determined and the corresponding two-sided 95% CIs calculated by using 
the exact uconditional CI based on the Farrington-Manning score statistic. 
Geometric means and 95% CIs will be calculated by taking the anti-logs of 
the means, and the 95% CI of the logtransformed immunogenicity 
parameters. Exact CIs based upon the binomial distribution will be 
calculated for percentages. 

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The analysis model for the Sclamp antibody, or the MN GMTs, will be 
performed using a general linear model on log-transformed (base 10) post-
GMT titres as the outcome variable and as covariates such as treatment 
groups (dose) and log-transformed pre-vaccination titre. Model adjusted 
differences in means (on the log scale) will be produced with 95% 
confidence limits. The estimated difference between treatment groups and 
the confidence limits will be back-transformed to obtain an adjusted GMT 
ratio with 95% confidence limits. 
The measure of the unadjusted GMT ratio based on post-vaccination GMT 
only will also be presented. 
In addition, reverse cumulative distribution plots will be generated to 
display the distribution of the antibody response at Days 29 and 57 for the 
active study phase, and will be explored for Days 209 and 396 (follow-up 
phase). Baseline titres for serum antibody to Sclamp, and MN titres to 
SARS-CoV-2 virus, will be less than or equal to the lower limit of 
quantitation (≤LLOQ) and will be imputed as ½ LLOQ. 
Bioanalysis of all samples up to, at least, Day 29 (initial status report Part 
1 only) and Day 57 should be completed prior to the initiation of the 
immunogenicity and statistical analyses.  
Safety Review Committee 
A Safety Review Committee (SRC) will be implemented to review safety 
data during scheduled periodic reviews. For Part 1 Cohorts 1, 2 and 3 the 
SRC will review safety data as described in the SRC charter and in the 
statistical analysis plan after safety data is available up to 48 hrs after 
dosing of the first 2 sentinel subjects in each cohort before proceeding with 
vaccination of the remaining subjects in each cohort (this process will be 
repeated again following administration of the second dose).  In addition, 
the SRC will review the aggregated/cumulative safety and tolerability data 
up to at least Day 8 for all subjects in each cohort before proceeding with 
vaccination of the next cohort (and similarly up to at least Day 36 
following the second vaccination dose at Day 29).  
Once all subjects in Part 1 have completed their first vaccination and 
safety evaluation, dosing will commence for Part 2 subjects (Cohorts 4,5 
and 6). The SRC will review the aggregated/cumulative safety and 
tolerability data up to at least Day 8 for all subjects in Cohorts, 4, 5 and 6 
before proceeding to the second vaccination dose. 
Pausing rules are defined in the protocol.  
Expected Start and End 
Dates: 
The clinical portion of the study should last approximately 14 months, 
consisting of approximately 2 months in the active study portion and a 
further 12 months of follow-up. Cohort 1 is expected to start in July 2020, 
and Cohort 6 is expected to complete the active study portion (up to 
Day 57) in December 2020, with the 12 month post-second dose 
assessments expected to be completed for Cohort 6 in November 2021.  

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3. 
List of Abbreviations and Definition of Terms 
 
ADCC 
Antibody Dependent Cellular Cytotoxicity 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALP 
Alkaline Phosphatase 
ALT 
Alanine Aminotransferase 
ASC 
Antibody Secreting Cell 
AST 
Aspartate Aminotransferase 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
CFR 
Code of Federal Regulations 
CK 
Creatinine Kinase 
COPD 
Chronic Obstructive Pulmonary Disease 
COVID-19 
Coronavirus Disease 2019 
CRF 
Case Report Form 
CSR 
Clinical Study Report 
CV 
Coefficient of Variation 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
ELISA 
Enzyme-Linked Immunosorbent Assay 
EMA 
European Medicines Agency 
FDA 
Food and Drug Administration 
FIH 
First In Human 
FSH 
Follicle Stimulating Hormone 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyltransferase 
GLP 
Good Laboratory Practice 
GMP 
Good Manufacturing Practice 
GMT 
Geometric Mean Titre 
GP 
General Practitioner 
HBsAg 
Hepatitis B Surface Antigen 
HCV 
Hepatitis C Virus 
hCG 
Human Chorionic Gonadotrophin 
HEENT 
Head, Eyes, Ears, Nose, and Throat 
HIV 
Human Immunodeficiency Virus 
HR 
Heart Rate 
HREC 
Human Research Ethics Committee 

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ICF 
Informed Consent Form 
IB 
Investigator’s Brochure 
ICH 
International Council for Harmonization 
IFN-γ 
Interferon Gamma 
IgX 
Immunoglobulin X i.e. Immunoglobulin A, Immunoglobulin G etc. 
IL-X 
Interleukin-X i.e. Interleukin-2, Interleukin-4 etc. 
IM 
Intramuscular 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
Kg 
Kilogram 
LDH 
Lactate Dehydrogenase 
LIMS 
Laboratory Information Management System 
LLN 
Lower Limit of Normal 
LLOQ 
Lower Limit of Quantitation 
MAAE 
Medically Attended Adverse Event 
Max. 
Maximum 
mcg 
Microgram 
MDMA 
3,4-methylenedioxymethamphetamine 
MERS-CoV 
Middle East Respiratory Syndrome Coronavirus 
mg 
Milligram 
Min. 
Minimum 
min 
Minute 
mL 
Millilitre 
mmHg 
Millimetres of Mercury 
MN 
Microneutralisation 
NAb 
Neutralising Antibody 
NOCD 
New Onset of Chronic Disease 
NTD 
N-Terminal Domain 
OTC 
Over-The-Counter 
PBMC 
Peripheral Blood Mononuclear Cell 
 
 
PCP 
Phencyclidine 
PCR 
Polymerase Chain Reaction 
PD 
Pharmacodynamic(s) 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RBD 
Receptor Binding Domain 
RT-PCR 
Reverse Transcription Polymerase Chain Reaction 

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SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SARS 
Severe Acute Respiratory Syndrome 
SARS-CoV-1 
SARS-Coronavirus-1 
SARS-CoV-2 
SARS-Coronavirus-2 
SD 
Standard Deviation 
SNMC 
Significant New Medical Condition 
SOP 
Standard Operating Procedure 
SpO2 
Peripheral Capillary Oxygen Saturation 
SRC 
Safety Review Committee 
TEAE 
Treatment-Emergent Adverse Event 
TFH cells 
Follicle Helper T Cells 
THC 
Tetrahydrocannabinol 
TNF-α 
Tumor Necrosis Factor Alpha 
ULN 
Upper Limit of Normal 
UQ 
The University of Queensland 
VMED 
Vaccine Mediated Enhanced Disease 
WBC 
White Blood Cell 
WHO 
World Health Organization 
WOCBP 
Women of Child Bearing Potential 

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4. 
Schedule of Events 
Visit Type 
Screening 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 51 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 1018 
*(Cohorts  
1-2 only) 
Visit 112 
Visit 122 
Ad Hoc Visit 
First 
Dose 
Safety 
Safety/ 
Immunol. 
Immunol. 
Second 
Dose3 / 
Immunol. 
Safety 
Safety/ 
Immunol. 
Immunol. 
Immunol. 
3-4 month 
follow-up 
6-month 
follow-up 
12-month 
follow-up / 
EOS 
Unscheduled 
Visit / Early 
Termination 
Study Day (Visit 
window) 
Day -28 to 
Day -1 
Day 1 
Day 24 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 29 
(±2 days) 
Day 
304 
(±2 
days) 
Day 36 
(±2 days) 
Day 43 
(±2 days) 
Day 57 
(±2 days) 
Day 120 
(+20 days) 
Day 209 
(±5 days) 
Day 394 
(±5 days) 
Ad Hoc 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review of 
Subject 
Eligibility 
X 
X5 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
(sex and race) 
and baseline 
characteristics 
including 
previous 
vaccination 
status 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical 
Examination 
X 
X6 
 
 
 
X6 
 
 
 
 
 
 
 
 
Height, Weight, 
BMI 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
SARS-CoV-2 
Test7 
X 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
Serology (HIV, 
Hepatitis B and 
C) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Injection site  
assessment8 
X 
X 
X 
X 
 
X 
X 
X 
 
 
 
 
 
(X)9 

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Visit Type 
Screening 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 51 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 1018 
*(Cohorts  
1-2 only) 
Visit 112 
Visit 122 
Ad Hoc Visit 
First 
Dose 
Safety 
Safety/ 
Immunol. 
Immunol. 
Second 
Dose3 / 
Immunol. 
Safety 
Safety/ 
Immunol. 
Immunol. 
Immunol. 
3-4 month 
follow-up 
6-month 
follow-up 
12-month 
follow-up / 
EOS 
Unscheduled 
Visit / Early 
Termination 
Study Day (Visit 
window) 
Day -28 to 
Day -1 
Day 1 
Day 24 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 29 
(±2 days) 
Day 
304 
(±2 
days) 
Day 36 
(±2 days) 
Day 43 
(±2 days) 
Day 57 
(±2 days) 
Day 120 
(+20 days) 
Day 209 
(±5 days) 
Day 394 
(±5 days) 
Ad Hoc 
Vital Signs 
Measurements 
(BP, HR, RR, TT 
and Oxygen 
Saturation 
(SpO2) 
X 
X 
X 
 
 
X 
X 
 
 
 
 
 
 
 
Serum Pregnancy 
Test (females) 
X 
(X)10 
 
 
 
(X)10 
 
 
 
 
 
 
 
 
Urine pregnancy 
test(females) 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
FSH test (to 
confirm 
menopausal 
female) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject Dosing 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
ECG 
X 
X 
X 
 
 
X 
X 
 
 
 
 
 
 
 
Urinalysis 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
X 
Post dose 
Monitoring11 
 
X 
X 
X 
 
X 
X 
X 
 
 
 
 
 
 
Training for 
Electronic Diary 
Completion 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Review of Diary 
entries12 
 
 
|-----------------------------------------------------------------------------------X-----------------------------------------------------------------------------------| 
X 
Electronic Diary 
Entry13 
 
 
|-----------------------------------------------------------------------------------X-----------------------------------------------------------------------------------| 
 
Concomitant 
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
X 
Adverse events14 
X 
 
|-----------------------------------------------------------------------------------X-----------------------------------------------------------------------------------| 
X 
Urine Drug Panel  
X 
X 
 
 
 
X 
 
 
 
 
 
 
 
 

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Visit Type 
Screening 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 51 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 1018 
*(Cohorts  
1-2 only) 
Visit 112 
Visit 122 
Ad Hoc Visit 
First 
Dose 
Safety 
Safety/ 
Immunol. 
Immunol. 
Second 
Dose3 / 
Immunol. 
Safety 
Safety/ 
Immunol. 
Immunol. 
Immunol. 
3-4 month 
follow-up 
6-month 
follow-up 
12-month 
follow-up / 
EOS 
Unscheduled 
Visit / Early 
Termination 
Study Day (Visit 
window) 
Day -28 to 
Day -1 
Day 1 
Day 24 
Day 8 
(±1 day) 
Day 15 
(±1 day) 
Day 29 
(±2 days) 
Day 
304 
(±2 
days) 
Day 36 
(±2 days) 
Day 43 
(±2 days) 
Day 57 
(±2 days) 
Day 120 
(+20 days) 
Day 209 
(±5 days) 
Day 394 
(±5 days) 
Ad Hoc 
Alcohol Breath 
Test 
X 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
Safety Lab Blood 
Samples15 
X 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
(X)16 
Immunology 
Samples17 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: EOS = End of Study, BMI = body mass index; BP = blood pressure; HR = heart rate; RR = respiratory rate, TT = tympanic temperature, 
PD = pharmacodynamic. 
1 On Day 29 immunological blood samples (test samples and retained blood samples) will be collected prior to second administration of treatment. 
2 6 and 12 month assessments will be measured from the time of completion of the second dose i.e. 6 and 12 months post-Day 29. 
3 Some subjects in Cohort 3 will be randomised to receive placebo in place of a second dose of study vaccine. 
4 Follow-up assessments on Days 2 and 30 will be aimed to be conducted as close to 24 hours post-dose as feasible, however in order to accommodate subject 
schedules these assessments may be conducted at any time during Days 2 and 30. In either case the time of each assessment will be recorded. 
5 Subject eligibility will be reviewed prior to study vaccine administration on Day 1.  
6 A brief physical examination will be performed at pre-dose (each dose, Days 1 and 29). 
7 In addition to a scheduled SARS-CoV-2 test at screening, and Days 1 and 29, subjects who display symptoms of COVID-19, or have been in close proximity to 
someone who has tested positive, maybe administered a SARS-CoV-2 test on an ad hoc basis. 
8 Injection site visual assessment will be conducted and/or reviewed before each dosing, 30 minutes, 24 hours (Days 2 and 30) and until 7 days post injection 
(Days 8 and 36). Subjects will be provided instructions on how to self-assess at home daily (from Day 1-8 and 29-36). 
9 In the event of early study termination, or an ad hoc visit, scheduled within the first 7 days post-dose (first or second dose) an injection site evaluation may be 
conducted. 
10 A negative urine pregnancy test must be documented prior to vaccination on Day 1 for WOCBP. A serum pregnancy test will be performed to confirm 
pregnancy status in the event of a positive urine pregnancy test. If the serum test is negative, the subject may receive their allocated treatment. 
11 Subjects will be monitored at the clinical site for a minimum of 2 hours post-dose,and will also return after 24 hours for a further safety assessment. 
12 Diaries will be reviewed to confirm completion by subjects and administer retraining as appropriate. Diaries will also be reviewed for safety oversight, and 
subjects may be asked to attend an unscheduled visit if required. 
13 Entries with the electronic diary will be throughout the study up to Day 57. Post-Day 57, additional entries may be made on an ad hoc basis.  
Study Symptoms form is completed daily from Day 1 to Day 8, and daily from Day 29 to Day 36. Other diary forms are completed as required for the duration of 
the study. 

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14 AEs will be recorded throughout the entire duration of the study. AEs identified via subject self-reporting using the electronic diary may be investigated and 
characterised on a case-by-case basis. 
15 Includes haematology (complete full and differential blood count, platelet count, haemoglobin, haematocrit, RBC count, WBC count, Neutrophils, 
Lymphocytes, Monocytes, Eosinophils, Basophils), coagulation (prothrombin time [PT] and partial thromboplastin time [APTT], Fibrinogen), and serum 
chemistry (albumin, amylase, AST, ALT, ALP, BUN or urea,  creatinine, calcium, creatine kinase, GGT, glucose random, LDH, potassium, phosphate, sodium, 
total bilirubin,  total protein, cholesterol, lipase). Pre-dose samples (Days 1 and 29) should nominally be drawn within 1 hour pre-dose, and post-dose samples 
(Days 2, 8, 30, 36 and 57) should nominally be drawn at the time of dosing on each respective day(within 30 minutes post dose) 
16 Additional safety blood samples may be drawn in the event of early termination to assist with safety assessment for subjects. 
17 Samples for immunological analyses include CD4+ and CD8+ T-cell analysis, ELISA, virus neutralisation, Luminex assay, and ADCC analysis. Day 57, 120 
and Day 394 samples will be tested for cross reaction in HIV point of care and rapid diagnostic tests. Pre-dose samples (Days 1 and 29) should nominally be 
drawn 1 hour pre-dose, and post-dose samples (Days 8, 15, 36, 43, 57, 209, and 394) should nominally be drawn at the time of dosing on each respective day.  
The number of samples to be drawn varies for each visit, please refer to Table 1, Section 9.9 in the protocol for a summary of the type, and total of samples to be 
collected at each study visit. Ad-hoc visit samples being collected are for ELISA, and virus neutralisation. 
18 Subset of participants from Cohorts 1-2 would be invited for an additiona visit at 3 months after thier second dose (Day 120). Samples from this visit will be 
tested for cross reaction in HIV point of care and rapid diagnostic tests. 
 

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5. 
Introduction 
5.1 
Background Information 
SARS-CoV-2 / COVID-19: In December 2019, China notified the World Health Organization 
(WHO) of an outbreak of human respiratory illness in the city of Wuhan. The infecting agent is a 
novel coronavirus, called SARS-CoV-2 which causes atypical pneumonia (COVID-19). Cases 
have now been reported worldwide, and the WHO declared the outbreak a pandemic in March 
2020 due to the levels of global spread and severity of the virus1.  
Previous novel coronaviruses include Middle East Respiratory Syndrome (MERS)-CoV, which 
emerged in 2012, and Severe Acute Respiratory Syndrome (SARS-CoV), which emerged in 2003. 
Both viruses are known to cause severe respiratory infections and are associated with a high case 
fatality rate. 
Although the virus is presumed zoonotic in origin, person-to-person spread is evident with a 
median incubation period of 3 days (range 0 to 24 days), and the time from symptom onset to 
developing pneumonia is 4 days (range 2 to 7 days). Transmission occurs through respiratory 
droplets or direct contact, other means of transmission such as faecal-to-oral transmission have not 
been ruled out.2 Symptoms of COVID-19 range from asymptomatic or mild to severe, and include 
fever, dry cough, and fatigue. The illness may evolve over the course of a week or longer, and in 
some cases progresses to acute respiratory distress syndrome and septic shock, requiring lengthy 
hospital stays.3  
There are currently no approved antiviral treatments or vaccinations for human coronavirus 
infections, although Remdesivir (Gilead) has recently been issued an Emergency Use 
Authorization in the U.S. for those hospitalized with severe disease. Globally, scientists are 
working to develop COVID-19-based vaccines. Treatment for infected individuals is symptom-
directed with supportive measures consisting of supplemental oxygen and conservative fluid 
administration. Compassionate use and trial protocols for several antiviral agents are underway. 
Vaccine technology: The University of Queensland (UQ) has developed a candidate vaccine to 
provide protection against SARS-CoV-2 infection and COVID-19. This candidate, SARS-CoV-2 
Sclamp, consists of the recombinant viral Spike glycoprotein (S) stabilized in its trimeric form, 
through the incorporation of the molecular clamp (MC) stabilization domain. This form is 
equivalent to that expressed on the virion surface and is thought to be the main target of a protective 
immune response. In order to create a suitable vaccine candidate, the SARS-CoV-2 S glycoprotein 
was further modified during screening to identify a form that could be produced as a soluble trimer. 
The research team at UQ have previously demonstrated the value of the MC for producing 
candidate subunit vaccines for ten different viruses in preclinical studies. In January 2019, UQ 
received funding from the Coalition of Epidemic Preparedness Innovations (CEPI) and 
commenced work to establish and validate a ‘Rapid Response Vaccine Pipeline’ based on the 
molecular clamp platform for the purpose of producing vaccine candidates in the event of a novel 
virus epidemic. In January 2020 in response to increasing global concern about a potential public 
health emergency, CEPI requested UQ to redirect their studies to generate a candidate subunit 

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vaccine for COVID-19 and to assess safety and effectiveness of the candidate vaccine in animal 
models in anticipation of accelerating progress to a Phase 1 clinical study. 
The SARS-CoV-2 Sclamp protein is produced by routine biopharmaceutical technologies which 
involve transfection of host Chinese Hamster Ovary (CHO) cells with plasmids encoding the 
modified gene for the clamped Spike protein. These cells are cultivated in suspension using protein 
free and animal component free media for production of the secreted recombinant protein. In order 
to facilitate rapid isolation of high purity material, the expressed protein is purified on an affinity 
column using a human monoclonal antibody directed against the molecular clamp domain. The 
material then undergoes additional downstream purification steps resulting in a high purity bulk 
protein which is aseptically dispensed into vials for clinical use. This protein is combined with 
adjuvant immediately prior to patient injection. 
Further information regarding the vaccine technology can be found in the Investigator’s 
Brochure.  
Adjuvant: To stimulate a robust and appropriate immune response, the SARS-CoV-2-S-clamp 
subunit protein is administered with an adjuvant. The squalene-oil-in-water adjuvant MF59C.1 
(Seqirus) has been selected due to its history of safe use in licenced vaccines for over 20 years with 
more than 100 million doses administered globally. An MF59C.1 adjuvanted influenza vaccine, 
Fluad™ is currently registered in Australia for use in persons aged 65 years and over for annual 
vaccination against influenza. Additionally, a H5N1 Pandemic vaccine, Aflunov™ is registered 
for use in persons aged 18 years and older, for vaccination in the event of an influenza H5N1 
pandemic being declared. Squalene-oil-in-water adjuvants have been well established to stimulate 
a balanced Th1/Th2 immune response that is expected to provide protection and mitigate the risk 
of any predisposition to enhanced disease via immunopathology. Studies have been designed and 
carried out using appropriate animal models, which further substantiate the safety and protective 
potential of SARS-CoV-2-Sclamp formulated with squalene-oil-in-water adjuvant MF59C.1 
(Seqirus). 
5.2 
Rationale for Study Design 
This will be a single centre, Phase 1, FIH, randomised, double-blind, placebo controlled, single 
and multiple ascending dose, 4-arm, parallel study.  
The study will be conducted in two parts: Part 1 will include a young healthy adult population aged 
≥ 18 - ≤ 55 years and Part 2 will include an older healthy adult population aged 56 years and over. 
Part 1 will be a single and multiple ascending dose, 4-arm, parallel study initiated before 
commencement of Part 2 so that safety can be assessed in the young adult population prior to 
exposure of the older adult population.  Part 2 will be a multiple ascending dose, 3-arm, parallel 
study. 
Since this is a FIH study with a novel vaccine antigen, a conservative approach to vaccine dosing 
will be adopted to ensure safety of study subjects. Sentinels will be used for cohorts 1, 2 and 3  
such that two randomly selected subjects will receive either the first dose of SARS-CoV-2 Sclamp 
vaccine or placebo on Day 1 (and again on Day 29 for the second dose). After at least 24 hours 
from the time of administration of the first doses a review of the immediate post-vaccination safety 
data will be conducted by the Safety Review Committee (SRC) in accordance with the study 

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protocol. Should there be no safety concerns, the remaining subjects in the cohort will be dosed. 
The step-wise dose escalation study design is an additional precautionary measure, where the lower 
dose cohort will complete their first vaccination, and the cumulative safety data from the first 7 
days will be evaluated by the SRC prior to initiating vaccination with sentinels of the intermediate 
dose of vaccine; same repeated at next (higher) dose level. After the first vaccination dose has been 
administered to Cohorts 1, 2 and 3 and the aggregated safety data reviewed, vaccination will be 
initiated for Cohorts 4, 5 and 6. 
Subjects will be randomised into 1 of 4 treatment arms across 3 cohorts in Part 1  or into 1 of 3 
treatment arms across 3 cohorts in Part 2, in a double-blinded manner. The double-blind will be 
maintained from first randomisation of an eligible subject until, at least, collection of data for all 
subjects is complete up to Day 57. After this day, the treatment assignment will be unblinded for 
all study team members, however subjects will remain blinded for the duration of the study. 
Subjects will also have access to an electronic or paper diary to capture solicited and unsolicited 
AEs and will be instructed to advise the clinical site if they have been diagnosed with COVID-19, 
shown symptoms of COVID-19, or returned from overseas in the interim period. Where an acute 
respiratory illness, or any other relevant signs or symptoms that are clinically suspect for 
COVID-19, is identified and confirmed by nasal/oropharyngeal swab and SARS-CoV-2 specific 
PCR, subjects will be advised to contact the clinical site immediately. Subjects will be given an 
information sheet that defines the symptoms for COVID-19 at the time of receipt of their first 
study vaccination. 
5.2.1 Analytes to be Measured 
Analysis of the humoral response for COVID-19 will include an ELISA for the SARS-CoV-2 
Sclamp antigen specific immune response, analysis of domain specificity and immunoglobulin 
isotype induction via Luminex Assay, analysis of microneutralisation (MN) assessed via SARS-
CoV-2 virus, and ADCC that will include assessment of potential correlates of protection. 
The induction of antigen specific T-cells will be assessed through the stimulation of peripheral 
blood mononuclear cells (PBMCs) with a vaccine specific peptide library and analysed by multi-
colour flow cytometry following surface staining for CD3, CD4, CD8, and intracellular cytokine 
staining for IFN-γ, TNF-α, IL-2, IL-4, IL-13, IL-17a, CD107a, and Granzyme B. 
5.2.2 Choice of the Dose 
The planned SARS-CoV-2 Sclamp doses to be investigated in this FIH study are 5, 15, and 45 mcg. 
The study is designed as a dose escalation study with the safety of the 5 mcg dose to be evaluated 
by a Safety Review Committee prior to escalation to the 15 mcg, and similarly prior to escalation 
to the 45 mcg dose. 
The starting dose of 5 mcg and highest dose of 45 mcg SARS-CoV-2 Sclamp are based on 
comparable viral subunit vaccines approved for use as outlined below and in the IB:  
RECOMBIVAX HB® (Hepatitis B vaccine, recombinant, Adjuvanted)  

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o Paediatric and adolescent formulation: Contains 5 mcg antigen + 0.25mg 
aluminium 
(provided 
as 
amorphous 
aluminium 
hydroxyphosphate) 
– 
Recommended 3 doses of 0.5 mL given by IM injection on a 0-, 1-, and 6-month 
schedule. 
o Adult (≥20 years) formulation: Contains 10 mcg antigen + 0.5mg aluminium 
(provided as amorphous aluminium hydroxyphosphate) - Recommended 3 doses of 
0.5 mL given by IM injection on a 0-, 1-, and 6-month schedule. 
• HEPLISAV-B® (Hepatitis B vaccine, recombinant, Adjuvanted)  
o Adult (≥18 years): Contains 20 mcg antigen + 3mg CPG-1018 - Recommended 
2 doses of 0.5 mL given by IM injection on a 0- and 1-month schedule. 
• GARDASIL®9 (Human Papillomavirus 9-valent vaccine, recombinant, Adjuvanted) 
o Children (>9 years) and adult: Contains 20 - 60 mcg antigen per strain for each of 
nine strains + 0.5mg aluminium (provided as amorphous aluminium 
hydroxyphosphate) – Recommended 3 doses of 0.5 mL given by IM injection on a 
0-, 2-, and 6-month schedule. 
• SHINGRIX® (Zoster Vaccine Recombinant, Adjuvanted),  
o Adult (>50 years): Reconstituted vaccine contains 50 mcg antigen + AS01b 
adjuvant – Recommended 2 doses of 0.5 mL given by IM injection on a 0-, 2-, and 
6-month schedule.  
Additionally, the choice of dose is supported by previous experience evaluating MC vaccines. 
Immunopathology and animal protection of SARS-CoV-2 Sclamp have investigated doses of 
5 mcg per dose in mice indicating that a neutralising immune response was induced by the SARS-
CoV-2 Sclamp vaccine. Further pre-clinical examinations in hamsters (also at 5 mcg per dose) and 
ferrets (at 20 mcg per dose), are ongoing, the results of which will be included in the SARS-CoV-
2 Sclamp Investigator’s Brochure.  

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Objectives and Endpoints 
5.3 
Study Objectives 
Primary Safety Objective: 
• To assess the safety and tolerability of SARS-CoV-2 Sclamp vaccine compared to placebo.  
Primary Immunogenicity Objective: 
• To assess the total serum antibody and neutralising antibody (NAb) immune responses 
elicited by SARS-CoV-2 Sclamp vaccine compared to placebo at Day 29 (28 days after 
first dose) and Day 57 (28 days after second dose). 
Secondary Immunogenicity Objective: 
• To compare the total serum antibody and NAb immune responses at Day 1 (baseline), Day 
15, Day 29 (28 days after the first dose), Day 43, Day 57 (28 days after the second dose), 
Day 209 (6 months after the second dose), and Day 394 (12 months after the second dose). 
Exploratory Immunogenicity Objectives: 
• To follow subjects for 12 months following second study treatment administration to 
record infections with SARS-CoV-2 and evaluate the frequency and severity of all cases 
of laboratory confirmed COVID-19 disease. 
• To conduct a detailed analysis of humoral and cellular immune responses elicited to 
Sclamp antigen upon vaccination compared to placebo and comparisons between dosing 
levels and across time course post-vaccination. 
• Assess whether SARS-CoV-2 Sclamp vaccination can cause false positives in subsequent 
HIV testing. If so, assess duration and range of this response. 
5.4 
Study Endpoints 
Primary Safety Endpoints: 
• Frequency, duration, and intensity of solicited local adverse events (AEs), including pain, 
redness, and induration for 7 days following each study treatment (for Days 1-3, Days 4-7 
and Days 1-7).  
• Frequency, duration, and intensity of solicited systemic adverse events (AEs), including 
fever, nausea, chills, diarrhoea, headache, fatigue, and myalgia for 7 days following each 
study treatment (for Days 1-3, Days 4-7 and Days 1-7). 
• Frequency, duration, intensity, duration, and relatedness of unsolicited AEs through to Day 
57. Frequency of Serious Adverse Events (SAEs), Medically-Attended Adverse Events 
(MAAEs), and any AEs leading to study withdrawal (including decision by the Principal 

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Investigator (PI) not to proceed with the second dose) at any time during study through to 
Day 394. Frequency and intensity of unsolicited AEs through to Days 57, 209, and 394 
Primary Immunogenicity Endpoints: 
• Geometric mean titre (GMT) of the serum antibody response to the Sclamp antigen 
compared to placebo by antigen specific ELISA at Day 29 (28 days after first dose) and 
Day 57 (28 days after second dose). 
• GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo by MN assay at 
Day 29 (28 days after first dose) and Day 57 (28 days after second dose). 
Secondary Immunogenicity Endpoints:  
• Proportion of subjects with ≥4 fold increase in titre above baseline by ELISA at Days 15, 
29, 43, 57, 209, and 394 post-first study treatment administration compared to placebo. 
• Proportion of subjects with ≥4 fold increase in titre above baseline by MN assay at Days 
15, 29, 43, 57, 209, and 394 post-first study treatment administration compared to placebo. 
• GMT of the serum antibody response to the Sclamp antigen compared to placebo by 
antigen specific ELISA at Days 1, 15, 29 (28 days after first dose), and Days 43, 57 
(28 days after second dose) and Days 209 and 394 (6 and 12 months post-second dose 
respectively). 
• GMT of the serum NAb titres to SARS-CoV-2 virus compared to by MN assay at Days 1, 
15, 29 (28 days after first dose), and Days 43, 57 (28 days after second dose) and Days 209, 
394. 
Exploratory Immunogenicity Endpoints: 
• Proportion of subjects experiencing laboratory confirmed SARS-CoV-2 infection and/or 
severity graded COVID-19 disease between Days 57 and 394 compared to placebo. 
• Proportion of subjects with titres of ≥1:80 and ≥ 1:160 by MN assay at Days 1, 15, 29, 43, 
57, 209, and 394 compared to placebo.  
• Proportion of subjects with ≥10 fold increase in titre above baseline by MN assay at Days 
1, 15, 29, 43, 57, 209, and 394 compared to placebo. 
• Proportion of subjects showing an increase in antigen specific CD4+ T-cells at Days 15, 
29, 36, 43, and 57 compared to prevaccination for vaccine antigen dose versus placebo. 
• Proportion of subjects showing an increase in antigen specific CD8+ T-cell at Days 15, 29, 
36, 43, and 57 compared to prevaccination for vaccine antigen dose versus placebo. 
• Evaluation of antibody dependent cellular cytotoxicity (ADCC) at Days 1, 15, 29, 43, 57, 
209, and 394 compared to placebo for vaccine antigen dose versus placebo. 

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• Evaluation of domain specificity of the elicited humoral immune response, specifically the 
proportion of antibodies elicited to the Receptor Binding Domain (RBD), N-Terminal 
Domain (NTD), and clamp trimerization domain by a custom Luminex assay and/or ELISA 
for vaccine antigen dose versus placebo on Days 1, 15, 29, 43, 57, 209, and 394. 
• Evaluation of antigen specific humoral immune responses including isotypes IgM, IgA, 
IgE, and subtypes IgG1, IgG2, IgG3, and IgG4 at Days 1, 15, 29, 43, 57, 209, and 394 
compared to placebo by a custom Luminex assay. 
• Evaluataion of participant blood samples by a range of HIV point of care and rapid 
diagnostic tests to determine if the post vaccination response results in a false positive 
outcome, and if so, the rate of false positive detection and duration of the response. 
6. 
Study Design 
This will be a single centre, Phase 1, FIH, double-blind, randomised, placebo controlled, single 
and sequential ascending dose, 4-arm parallel study to evaluate the safety, tolerability, and 
immunogenicity of the SARS-CoV-2 Sclamp vaccine. 
The study will be conducted in two parts: Part 1 will include a young healthy adult population aged 
≥ 18 - ≤ 55 years and Part 2 will include an older healthy adult population aged 56 years and over. 
Part 1 will be a single and multiple ascending dose, 4-arm, parallel study initiated before 
commencement of Part 2 so that safety can be assessed in the young adult population prior to 
exposure of the older adult population.  Part 2 will be a multiple ascending dose, 3-arm, parallel 
study. 
The study will evaluate a single formulation of SARS-CoV-2 Sclamp protein subunit vaccine 
administered as a single dose or two doses of varying vaccine antigen concentrations in distinct 
cohorts.  
Four treatments (A, B, C, and D) will be administered to subjects. 
This study will consist of 6 cohorts: 2 cohorts of a lower dose (Treatment A), 2 cohorts of an 
intermediate dose (Treatment B), 1 cohort of a higher dose (Treatment C)(Part 2 only), and 1 
cohort of a higher dose, examining both a two dose regimen (Treatment C) and a single dose 
vaccination regimen (Treatment D) (Part 1 only).  
Cohorts 1,2 and 3 will include subjects aged  ≥ 18 - ≤ 55 years of age and cohorts 4, 5 and 6 will 
include subjects aged 56 years and older. Cohorts 4, 5 and 6 will include an approximately equal 
number of subjects aged ≥ 56 - ≤ 65 years of age,  and  ≥ 66 years and over.  
Part 1: Cohort 1 will include 32 subjects; of these 8 will receive placebo, and 24 subjects will 
receive Treatment A. Cohort 2 will include 32 subjects; of these 8 will receive placebo, and 
24 subjects will receive Treatment B. Cohort 3 will include 56 subjects; of these 8 will receive 
placebo, 24 subjects will receive Treatment C, and 24 subjects will receive Treatment D. 
Part 2: Cohort 4 will include 32 subjects; of these 8 will receive placebo, and 24 subjects will 
receive Treatment A. Cohort 5 will include 32 subjects; of these 8 will receive placebo, and 

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24 subjects will receive Treatment B. Cohort 6 will include 32 subjects; of these 8 will receive 
placebo, and 24 subjects will receive Treatment C. 
 
Sentinels will be used for cohorts 1, 2 and 3 such that the first two subjects will receive either the 
first dose of SARS-CoV-2 Sclamp vaccine or placebo. After at least 24 hours from the time of 
administration of the first doses a review of the immediate post-vaccination safety data will be 
conducted by the Safety Review Committee (SRC) in accordance with the study protocol. Should 
there be no safety concerns, the remaining subjects in each cohort will be dosed. The step-wise 
dose escalation study design is an additional precautionary measure, where the lower dose cohort 
will complete their first vaccination, and the cumulative safety data from the first 7 days will be 
evaluated by the SRC prior to initiating vaccination with the next higher dose of vaccine.  
Despite consisting of 2 separate treatments, Cohort 3 will include only include 2 sentinels, 
1 placebo and 1 active from Treatment C only, as Treatments C and D are functionally identical 
until the second dose of active or placebo (respectively) is scheduled 28 days later. The sentinel 
will not be randomised between Treatment C and D as Treatment D will receive placebo as a 
second dose, and accordingly no sentinel is required to ensure optimal safety. 
Cohorts will be dosed sequentially, and escalation from Cohort 1 to Cohort 3 will be authorised 
by the SRC if no safety events of concern are observed in subjects up to Day 8 following review 
of the cumulative safety data of each Cohort. 
After the first vaccination dose has been administered to Cohorts 1, 2 and 3 and the aggregated 
safety data reviewed by the SRC, vaccination will be initiated for Cohorts 4, 5 and 6.  These 
Cohorts will not include sentinels, however, the SRC will review the aggregated/cumulative safety 
and tolerability data up to at least Day 8 post vaccination for all subjects in each of Cohorts 4, 5 
and 6 by cohort before proceeding to the second vaccination dose. 
Treatment 
Dose regimen 
Treatment A 
(Cohorts 1 & 
4) 
SARS-CoV-2 Sclamp vaccine 1 x 5 mcg, or placebo, administered in a two 
dose regimen, at least 28 days apart 
Treatment B 
(Cohorts 2 & 
5) 
SARS-CoV-2 Sclamp vaccine 1 x 15 mcg, or placebo, administered in a two 
dose regimen, at least 28 days apart 
Treatment C 
(Cohorts 3 & 
6) 
 SARS-CoV-2 Sclamp vaccine 1 x 45 mcg, or placebo, administered in a two 
dose regiment, at least 28 days apart 
Treatment D 
(Cohort 3 
only) 
SARS-CoV-2 Sclamp vaccine 1 x 45 mcg, or placebo, administered as a 
single dose, followed by placebo as the second dose at least 28 days apart 

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The same authorisation review process will again be repeated at the second dose. 
The study design is summarised in Figure 1. 
 
 
1 As Treatments C and D are functionally identical until Day 29, the active sentinel subject from Treatment C will 
serve as a sentinel for both treatments at first dose. At second dose, no sentinel is required for Treatment D as the 
placebo will be administered. 
Cohort 1 Sentinel
n=2
1 Treatment A 
1 Placebo
• SRC will decide 
to continue to 
Cohort 1 ROC 
after safety data 
up to Day 2
• Decision 
requires, at 
minimum, email 
confirmation 
from voting 
members
Cohort 1 ROC
n = 30
23 Treatment A
7 Placebo
• SRC will decide 
to continue to 
Cohort 2 based 
on safety data up 
to day 8
• Decision requires 
formals SRC 
meeting
Cohort 2 Sentinel
n=2
1 Treatment B 
1 Placebo
• SRC will decide 
to continue to 
Cohort 2 ROC 
after safety data 
up to Day 2
• Decision 
requires, at 
minimum, email 
confirmation 
from voting 
members
Cohort 2 ROC
n = 30
23 Treatment B
7 Placebo
• SRC will decide 
to continue to 
Cohort 3 based 
on safety data up 
to Day 8
• Decision requires 
formal SRC 
meeting
Cohort 3 Sentinel
n = 2
1 Treatment C1
1 Placebo
• SRC will decide 
to continue to 
Cohort 3 ROC 
after safety data 
up to Day 2
• Decision 
requires, at 
minimum, email 
confirmation 
from voting 
members
Cohort 3 ROC
n = 54
23 Treatment C
24 Treatment D
7 Placebo
• SRC will decide 
to continue to 
Cohort 4, 5 and 6 
based on safety 
data from cohort 
3 to day 8
• Decision 
requires, at 
minimum, email 
confirmation 
from vosting 
members
Cohortd 4, 5 and 6
n = 96 
24 Treastment A
24 Treatment B
24 Treatment C
24 Placbo

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Figure 1: Visual Schematic for Study Design  
6.1 
Study Progression and Evaluations 
The study will progress from Cohort 1 to Cohort 2, and from Cohort 2 to Cohort 3 when the 
cumulative safety data of the previous cohort up to Day 8 have been collected and, reviewed by 
the SRC, and who will provide authorisation to proceed to the next dose cohort by the process 
described in Section 7.1. Vaccination for Cohorts 4, 5 and 6 will be initated only once the SRC 
have completed their review of the aggregated safety and tolerability data from Cohorts 1, 2 and 
3. 
Adjustment to the currently outlined subsequent dose level, dosing regimen, and period of subjects' 
follow-up may be made by the SRC based on data from the prior completed dose level. However, 
the total dose to be administered in a given cohort will not exceed the one currently outlined in the 
protocol. 
6.2 
Starting Dose  
The planned starting dose of 5 mcg administered twice in subjects has been selected based on 
reported dose levels of comparable viral subunit vaccines approved for use (as described in Section 
5.2.2, and the IB). Of these comparable vaccines highlighted, the selected dose represents between 
a 3- to 18-fold decrease (compared to RECOMBIVAX HB® and GARDASIL®9 respectively) in 
total exposure, therefore this initial starting dose is deemed to be a suitable dose to establish initial 
safety information for the SARS-CoV-2 Sclamp vaccine for dose escalation purposes. 
6.3 
Dose Escalation Scheme 
7. 
The proposed escalation scheme for the study consists of two three-fold dose 
increments. The planned dose range of 5 mcg to 15 mcg to 45 mcg administered twice 
28 days apart was selected to minimize the risk to the subjects while ensuring the 
evaluation of an exposure range that encompasses and exceeds the expected level to 
achieve an immunological response. Dose Escalation Criteria 
7.1 
Data Review by the Safety Review Committee 
The SRC will be responsible for the assessment of available safety and tolerability data for each 
cohort and to make decisions with regards to study progression through the three cohorts in Part 1 
and prior to initiating vaccination for Part 2. The SRC will be composed of at least the PI, one 
Sponsor representative, and a Syneos Health Medical Monitor. Additional non-voting members of 
the SRC may also be included in the SRC to contribute to discussions, but will not have a vote in 
the decision to progress to a new cohort. The conduct of the SRC during the study will be as 
dictated in the SRC Charter. 
In Part 1, for the purpose of progressing from sentinels to dosing the rest of cohort (ROC), an 
informal SRC discussion will be held after the sentinel’s safety data are available for 48-hours post 
dose (Day 2). If no AEs of note, SAEs, or severe AEs, dosing of the ROC may be conducted 

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without a formal SRC meeting, and dosing may commence with email confirmation from the SRC 
members (this process will be repeated again following administration of the second dose). 
For the purpose of progressing from Cohort 1 to Cohort 2 and from Cohort 2 to Cohort 3, a formal 
SRC meeting will be held after aggregated safety and tolerability data up to at least Day 8 (7 days 
post-first dose) are available for all eligible subjects from each cohort before proceeding with 
vaccination of the next cohort (and similarly up to at least Day 36 following the second vaccination 
dose at Day 29). As the maximal immunological response is not expected to be reached by Day 8, 
immunological data will not be assessed as part of the SRC decision making process.  
The potential decisions of the SRC are: 
1. Escalate to the next planned dose level; or 
2. Suspend dose escalation until further review of study data can be made, allowing the SRC 
to determine whether predefined halting rules have been met. Dose escalation may resume 
once the SRC concludes that no halting rules have been met; or 
3. Stop dose escalation; 
4. Terminate the study. 
The SRC will conduct a blinded review of the data; however the blind may be broken for individual 
subjects if judged necessary, prior to making a decision on dose escalation. Dose escalation may 
occur only following mutual agreement between the SRC members. Decisions taken by the SRC 
will be documented and submitted to the HREC overseeing the study, along with supportive data.  
7.2 
Dose Halting Rules 
The following sections define halting rules, which are pre-defined criteria that halt the conduct of 
the study (either a single cohort or the entire study). These rules are to ensure the safety of study 
subjects. The following criteria including grading scales to be used in this study are based on the 
CBER (FDA) Guidance for Industry “Toxicity Grading Scale of Healthy Adult and Adolescent 
Volunteers Enrolled in Preventative Vaccine Clinical Trials”.4 Specific safety terms and reaction 
grading criteria are defined in Section 9.15. 
Dosing of all subjects in a cohort shall be halted for any event suggesting that there is a significant 
safety risk to other subjects of the cohort, or when a clinically significant pattern of toxicity is 
apparent in more than one subject. The following events will result in a temporary halt of dosing 
within that cohort: 
• The occurrence of a SAE assessed, as possibly or probably related to the study vaccine; 
• The occurrence of a clinically significant unsolicited severe AE (Grade 3 AE), including 
vital signs, and/or a laboratory abnormality assessed as possibly or probably related to the 
study vaccine in ≥2 subjects in the same cohort; or 
• 2 or more of the subjects enrolled in each cohort experience a severe (Grade 3):  

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o Allergic reaction (e.g., hives, angioedema, allergic asthma, systemic anaphylaxis) 
that is assessed as related to study vaccine; or 
o Vaccine-related injection site ulceration, abscess, or necrosis.  
If any of the above halting rules are met, dosing will be suspended for all subjects in that cohort, 
while continuation of other cohorts at lower or equivalent dose levels will be evaluated on a case-
by-case basis. The SRC will review details of the event(s) and/or additional data. If, after further 
review of the data, the SRC determines that no halting rules have been met e.g., AE determined to 
be unrelated to the study vaccine, then dosing of the cohort may resume. 
The Sponsor or the Investigator (after consultation with the Sponsor) has the right to discontinue 
the study at any time. If the clinical study is prematurely terminated, the clinical site must promptly 
inform the study subjects and must ensure that appropriate treatment and follow-up for the subjects 
is made available. The Sponsor must notify the HREC should the study be discontinued. 
8. 
Study Population 
8.1 
Rationale for the Study Population 
A healthy volunteer population has been selected for Part 1 of the study because healthy subjects 
with no clinically significant acute or chronic diseases or conditions represent a homogenous 
population allowing for proper evaluation of the safety and tolerability of a vaccine while 
minimising the impact of additional confounding factors. No reproductive studies in animals have 
been conducted with the study vaccine (SARS-CoV-2 Sclamp vaccine) so far. Since the risks to a 
developing human foetus, or a nursing infant, following exposure to SARS-CoV-2 Sclamp vaccine 
are unknown at this time, only males and non-pregnant, non-lactating females will be enrolled in 
this study. Female subjects of childbearing potential and non-surgically-sterile male subjects with 
female partners of childbearing potential will be required to use a double contraceptive method for 
the duration of the study and for 90 days following the last administration of the study treatment. 
A serum pregnancy test will be performed at screening for all women of child bearing potential, 
and urine pregnancy tests will also be performed prior to each dosing to confirm non-pregnant 
status.  
A healthy older adult population has been selected for Part 2 of the study because older adults have 
been identified to be at greatest risk of severe disease, hospitalisation and death from COVID-19 
(with risk increasing continuously from 60-years of age, and much higher over 70-years). 
However, it is important that these older adults have no medical co-morbidities associated with an 
increased risk of severe COVID-19. The ability to induce a robust immune response declines with 
age, therefore it is important to understand the profile of the immune response between young 
healthy and older adult populations to evaluate the immunogenicity of the doses tested for the 
vaccine. The inclusion of a healthy older adult population will enable a comparison of the 
preliminary immunogenicity and safety characteristics between the two age groups in the study to 
inform the selection of dose, prior to progression of further clinical development of the vaccine. 
As the study will not be assessing pharmacokinetic parameters, there is no anticipated impact of 
including smokers in the population, and smoker status is considered unlikely to impact the aims 
of the study. It is recognised, however that smokers tend to have higher rates of respiratory and 

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cardiovascular issues, as well as a higher chance of contracting lung and chest infections. The 
inclusion of smokers in the study will therefore, be limited only to social smokers, defined as those 
who smoke the equivalent of no more than 10 cigarettes per week. Ex-heavy smokers (heavy 
smoking defined as the equivalent of 25 or more cigarettes per day) may be admitted to the study 
if they have quit, or reduced their cigarette intake to the defined level of social smoking, for a 
period of at least 12 months. Further, smokers will be required to abstain from smoking for a 
minimum of 2 hours prior to each visit to the clinical site, and for at least 4 hours post each study 
treatment administration.  
8.2 
Sample Size 
It is planned to enroll approximately  216 male and female volunteers for participation in this 
study. 
This study will consist of 6 cohorts (2 cohorts of a lower dose, 2 cohorts of an intermediate dose 
and 2 cohorts of a higher dose, examining both a single and two dose vaccination regimen). Cohort 
1 will include 32 subjects (8 receiving placebo and 24 subjects receiving a low-dose of SARS-
CoV-2 Sclamp vaccine administered in a two dose regimen 28 days apart).  
Cohort 2 will include 32 subjects (8 receiving placebo and 24 subjects receiving an intermediate 
dose of SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days apart).  
Cohort 3 will include 56 subjects (8 subjects receiving placebo, 24 subjects receiving a higher dose 
of SARS-CoV2 Sclamp vaccine administered in a two dose regimen 28 days apart, and 24 subjects 
receiving a single dose of the high-dose of SARS-CoV-2 Sclamp vaccine dosed once followed by 
placebo 28 days later). 
Cohort 4 will include 32 subjects (8 receiving placebo and 24 subjects receiving a lower dose of 
SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days apart).  
Cohort 5 will include 32 subjects (8 receiving placebo and 24 subjects receiving an intermediate 
dose of SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days apart).  
Cohort 6 will include 32 subjects (8 subjects receiving placebo, 24 subjects receiving a higher dose 
of SARS-CoV-2 Sclamp vaccine administered in a two dose regimen 28 days apart). 
No prospective calculations of statistical power have been made. The sample size of 24 subjects 
per treatment group has been selected to provide information on safety and estimates related to the 
primary and secondary endpoints. 
8.3 
Inclusion Criteria 
Subjects enrolled in this study will be members of the community at large. The recruitment 
advertisements may use various media types (e.g., radio, newspaper, the clinical site Web site and 
volunteer database).  
Part 1 Subjects must meet all of the following criteria to be included in the study: 

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1. Healthy male or non-pregnant female, ≥18 and ≤55 years of age, with BMI >18 and <34.0 
kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.  
2. Healthy as defined by: 
a. The absence of clinically significant illness and surgery within 28 days prior 
to dosing. Subjects displaying signs or symptoms of an acute and/or febrile 
illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days 
required) will be carefully evaluated for upcoming illness/disease. Inclusion 
pre-dosing is at the discretion of the Investigator, and the subject may have 
their scheduled dosing postponed until the condition resolves. 
b. The absence of clinically significant history of neurological, endocrine, 
cardiovascular, respiratory, haematological, immunological, psychiatric, 
gastrointestinal, renal, hepatic, and metabolic disease. 
3. Non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per 
week). Ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more 
cigarettes per day) may be admitted if they have quit,or reduced their cigarette intake to 
the defined level of social smoking, for a period of at least 12 months. 
4. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP 
must be able and willing to use at least 2 highly effective methods of contraception  
commencing at enrolment, during the study and for 3 months after last treatment 
administration. A female subject is considered to be a WOCBP following menarche and 
until she is in a post-menopausal state for 12 consecutive months (without an alternative 
medical cause) or otherwise permanently sterile (for which acceptable methods include 
hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). A follicle-stimulating 
hormone (FSH) test may be used to confirm post-menopausal state. Examples of acceptable 
methods of contraceptive methods (for female subjects) to be used throughout the study 
include: 
a. Simultaneous use of hormonal contraceptives, started at least 28 days prior to first 
study treatment administration and must agree to use the same hormonal 
contraceptive throughout the study, and condom for the male partner; 
b. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior 
to first study treatment administration, and condom for the male partner; 
c. Simultaneous use of diaphragm or cervical cap and male condom for the male 
partner, started at least 28 days prior to first study treatment administration; 
d. Sterile male partner (vasectomized since at least 6 months prior to first study 
treatment administration); 
e. True abstinence, defined as no sexual intercourse with a male partner, (for 
heterosexual couples) for at least 28 days prior to first study treatment 
administration and for at least the duration of the study. Periodic abstinence and 
withdrawal are not acceptable methods. 

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5. WOCBP must have a negative urine pregnancy test prior to receiving each dose. 
6. Male subjects (including men who have had a vasectomy) with a pregnant partner, a female 
partner not of childbearing potential, or a same sex partner, must agree to use a condom 
from the first study treatment administration until at least 90 days after the last study 
treatment administration. 
7. Male subjects must be willing not to donate sperm until 90 days following the last study 
treatment administration. 
8. Must be able to attend all visits for the duration of the study and to comply with all study 
procedures according to the study schedule. 
9. Capable of, and have given, written informed consent. 
 
Part 2 Subjects must meet all of the following criteria to be included in the study: 
1. Healthy male or non-pregnant female, ≥56 years of age, with BMI >18 and <34.0 kg/m2 
and body weight ≥50.0 kg for males and ≥45.0 kg for females.  
2. Healthy as defined by: 
a. The absence of clinically significant illness and surgery within 28 days prior 
to dosing. Subjects displaying signs or symptoms of an acute and/or febrile 
illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days 
required) will be carefully evaluated for upcoming illness/disease. Inclusion 
pre-dosing is at the discretion of the Investigator, and the subject may have 
their scheduled dosing postponed until the condition resolves. 
b. The absence of clinically significant history of  a pre-existing medical 
condition that is not stable (neurological, endocrine, cardiovascular, 
respiratory, haematological, immunological, psychiatric, gastrointestinal, 
renal, hepatic, and metabolic disease). A stable medical condition is defined 
as disease not requiring significant change in therapy or hospitalization for 
worsening disease during the 3 months before enrolment. 
3. Non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per 
week). Ex-heavy smokers (heavy smoking defined as the equivalent of 25 or more 
cigarettes per day) may be admitted if they have quit,or reduced their cigarette intake to 
the defined level of social smoking, for a period of at least 12 months. 
4. Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP 
must be able and willing to use at least 2 highly effective methods of contraception  
commencing at enrolment, during the study and for 3 months after last treatment 
administration. A female subject is considered to be a WOCBP following menarche and 
until she is in a post-menopausal state for 12 consecutive months (without an alternative 
medical cause) or otherwise permanently sterile (for which acceptable methods include 
hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). A follicle-stimulating 

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hormone (FSH) test may be used to confirm post-menopausal state. Examples of acceptable 
methods of contraceptive methods (for female subjects) to be used throughout the study 
include: 
a. Simultaneous use of hormonal contraceptives, started at least 28 days prior to first 
study treatment administration and must agree to use the same hormonal 
contraceptive throughout the study, and condom for the male partner; 
b. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior 
to first study treatment administration, and condom for the male partner; 
c. Simultaneous use of diaphragm or cervical cap and male condom for the male 
partner, started at least 28 days prior to first study treatment administration; 
d. Sterile male partner (vasectomized since at least 6 months prior to first study 
treatment administration); 
e. True abstinence, defined as no sexual intercourse with a male partner, (for 
heterosexual couples) for at least 28 days prior to first study treatment 
administration and for at least the duration of the study. Periodic abstinence and 
withdrawal are not acceptable methods. 
5. WOCBP must have a negative urine pregnancy test prior to receiving each dose. 
6. Male subjects (including men who have had a vasectomy) with a pregnant partner, a female 
partner not of childbearing potential, or a same sex partner, must agree to use a condom 
from the first study treatment administration until at least 90 days after the last study 
treatment administration. 
7. Male subjects must be willing not to donate sperm until 90 days following the last study 
treatment administration. 
8. Must be able to attend all visits for the duration of the study and to comply with all study 
procedures according to the study schedule. 
9. Capable of, and have given, written informed consent.  
 
8.4 
Exclusion Criteria 
Part 1:  
Subjects to whom any of the following applies will be excluded from the study: 
1. Any clinically significant abnormality or vital sign abnormality at physical examination 
(including baseline high blood pressure [140/90] after 3 repeated measurements or high 
random blood sugar [non-fasting]), clinically significant abnormal laboratory test results 
or positive test for HIV, hepatitis B, or hepatitis C found during medical screening. 

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2. Any acute or chronic ongoing illness which, in the judgement of the investigator, may 
preclude the subject’s participation.  
3. Any subject that has an active COVID-19 infection (positive COVID-19 test: 
nasal/oropharyngeal swab and/or positive serum antibody response) at screening, or Day 1, 
or has been in close contact with someone who has an active COVID-19 infection, or has 
recovered from a previous COVID-19, SARS-CoV--1, or MERS infection. 
4. Positive pregnancy, urine drug screen, or alcohol breath test at screening. 
5. Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in 
the formulation (including the adjuvant, MF59C.1). 
6. Presence of a known, or suspected, impairment of the immune system including, but not 
limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. 
7. History of a known, or suspected, respiratory system disorder including, but not limited to, 
cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic 
obstructive pulmonary disease (COPD), or asthma, excluding childhood asthma. 
8. History of significant alcohol abuse within 12 months year prior to screening. 
9. Positive test for drugs of abuse (such as marijuana/tetrahydrocannabinol [THC] products, 
amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, 
opiates, methylenedioxymethamphetamine [MDMA], or phencyclidine [PCP]) at 
screening, prior to dosing, or a history of drug abuse within 12 months prior to screening. 
10. Participation in a clinical research study involving the administration of an investigational, 
or marketed, drug or device within 30 days prior to receiving the first treatment 
administration, or administration of a biological product in the context of a clinical research 
study within 90 days prior to the first dosing, or concomitant participation in an 
investigational study involving no drug, vaccine, or device administration, or intent to 
participate in another clinical study at any time during the conduct of the study. 
11. Use of medications for the timeframes specified below, with the exception of hormonal 
contraceptives and medications exempted by the Investigator on a case-by-case basis 
because they are judged to interfere with subject safety e.g., topical drug products without 
significant systemic absorption are permissible:  
a. Prescription medication within 14 days prior to the first dosing; 
b. Any medication, or treatments, that may affect the immune system such as allergy 
injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or 
other drugs known to be frequently associated with significant major organ toxicity 
within 90 days prior to enrolment; 
c. Any registered vaccine administered within 30 days prior to enrolment in the study, 
or who plan to receive any non-study vaccines within 28 days of the second dose 
of the study vaccine 

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d. Any other investigational coronavirus vaccine i.e. SARS--CoV-1, SARS--CoV-2, 
MERS etc. at any time prior to, or during, the study.  
e. Over-the-counter products within 7 days prior to the first dosing, with the exception 
of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins. 
 
12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding 
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 
499 mL within 56 days prior to the first dosing. 
13. Receipt of blood products within 2 months prior to the first study treatment administration 
(Day 1), or planned receipt of blood products during the study period. 
14. Breast-feeding subject, or subject who plans to breastfeed from the time of first dose 
through 60 days after last study treatment administration. 
15. Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the 
injection site which, in the opinion of the Investigator, may inhibit the ability to effectively 
perform an injection site assessment.  
16. Employee or immediate relative of an employee of the clinical site, any of its affiliates or 
partners, or Syneos Health. 
17. Any reason which, in the opinion of the Investigator, would interfere with the primary 
study objectives or prevent the subject from participating in the study. 
 
Part 2  
Subjects to whom any of the following applies will be excluded from the study: 
1. Any clinically significant abnormality or vital sign abnormality at physical examination, 
or uncontrolled hyertension in adults aged ≥ 56 years and older ,or high random blood 
sugar [non-fasting]), clinically significant abnormal laboratory test results or positive test 
for HIV, hepatitis B, or hepatitis C found during medical screening. 
2. Any acute or chronic ongoing illness which, in the judgement of the investigator, may 
preclude the subject’s participation.  
3. Any subject that has an active COVID-19 infection (positive COVID-19 test: 
nasal/oropharyngeal swab and/or positive serum antibody response) at screening, or Day 1, 
or has been in close contact with someone who has an active COVID-19 infection, or has 
recovered from a previous COVID-19, SARS-CoV-1, or MERS infection. 
4. Positive pregnancy, urine drug screen, or alcohol breath test at screening. 
5. Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in 
the formulation (including the adjuvant, MF59C.1). 

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6. Presence of a known, or suspected, impairment of the immune system including, but not 
limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus. 
7. History of a known, or suspected, or currently unstable medical condition that may expose 
the participant to an increased risk for severe SARS-CoV-2 disease, such as a respiratory 
system disorder including, but not limited to, cystic fibrosis, reactive airway disease, 
emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or 
asthma, excluding childhood asthma, uncontrolled hypertension, ischemic or structural 
heart disease, chronic kidney disease,  chronic liver disease, endocrine disorder and 
neurological illness. 
8. History of significant alcohol abuse within 12 months prior to screening. 
9. Positive test for drugs of abuse (such as marijuana/tetrahydrocannabinol [THC] products, 
amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, 
opiates, methylenedioxymethamphetamine [MDMA], or phencyclidine [PCP]) at 
screening, prior to dosing, or a history of drug abuse within 12 months prior to screening. 
10. Participation in a clinical research study involving the administration of an investigational, 
or marketed, drug or device within 30 days prior to receiving the first treatment 
administration, or administration of a biological product in the context of a clinical research 
study within 90 days prior to the first dosing, or concomitant participation in an 
investigational study involving no drug, vaccine, or device administration, or intent to 
participate in another clinical study at any time during the conduct of the study. 
11. Use of medications for the timeframes specified below, with the exception of hormonal 
contraceptives and medications exempted by the Investigator on a case-by-case basis 
because they are judged to interfere with subject safety e.g., topical drug products without 
significant systemic absorption are permissible:  
a. Prescription medication within 14 days prior to the first dosing that in the opinion 
of the Investigator could impact the subjects safe participation in the study; 
b. Any medication, or treatments, that may affect the immune system such as allergy 
injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or 
other drugs known to be frequently associated with significant major organ toxicity 
within 90 days prior to enrolment; 
c. Any registered vaccine administered within 30 days prior to enrolment in the study, 
or who plan to receive any non-study vaccines within 28 days of the second dose 
of the study vaccine 
d. Any other investigational coronoavirus vaccine i.e. SARS-CoV-1, SARS-CoV-2, 
MERS etc. at any time prior to, or during, the study.  
e. Over-the-counter products within 7 days prior to the first dosing, that in the 
opinion of the investigator could impact the subjects safe participation in the 
study. Paracetamol (up to 2 g daily) and standard dose vitamins will be permitted. 

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12. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding 
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 
499 mL within 56 days prior to the first dosing. 
13. Receipt of blood products within 2 months prior to the first study treatment administration 
(Day 1), or planned receipt of blood products during the study period. 
14. Breast-feeding subject, or subject who plans to breastfeed from the time of first dose 
through 60 days after last study treatment administration. 
15. Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the 
injection site which, in the opinion of the Investigator, may inhibit the ability to effectively 
perform an injection site assessment.  
16. Employee or immediate relative of an employee of the clinical site, any of its affiliates or 
partners, or Syneos Health. 
17. Any reason which, in the opinion of the Investigator, would interfere with the primary 
study objectives or prevent the subject from participating in the study. 
18. Permanent resident in an aged care facility (nursing or aged care home. 
9. 
Clinical Procedures 
Unless otherwise specified, procedures, data collection and evaluation will be conducted as per the 
clinical site SOPs. 
9.1 
Screening Procedures 
Subject screening procedures will be performed within 28 days preceding administration of study 
medication. Subjects must provide written informed consent prior to initiation of any screening 
procedures. The consent to perform some general screening procedures may be obtained on a 
consent document other than the Informed Consent Form (ICF) specific to this study, and 
therefore, some screening test results could be obtained before signature of the ICF specific to this 
study. The study-specific ICF must be signed and dated by the subject before participation to study-
specific procedures. 
Screening procedures will include: demographic data, medical and medication histories, such as 
history of diabetes mellitus, hypertension and asthma, excluding childhood asthma, physical 
examination, body measurements, vital signs (BP, HR, RR, and TT), ECG, oxygen saturation 
(SpO2), haematology, biochemistry, random blood sugar (non-fasting), coagulation (PT, APTT, 
and fibrinogen), serology (HIV, hepatitis B and C tests), SARS-CoV-2 test (nasal/oropharyngeal 
swab and RT-PCR, and serum antibodies by ELISA), urinalysis, serum pregnancy test, alcohol 
breath test, and urine drug screen. 
Women not of childbearing potential must be post-menopausal, defined as cessation of regular 
menstrual periods for at least 12 months and  confirmed by  FSH level  at screening, unless 
documented FSH and estradiol tests performed at the clinical site within 6 months prior to 
administration of the study medication are available. For women using hormone replacement 

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therapy and in whom FSH level have to be confirmed, this test will be performed at least one week 
following the withdrawal of the therapy, but before the first dosing. 
For eligibility purposes, abnormal laboratory or vital signs results may be repeated at the discretion 
of the PI if an abnormal result is observed at the initial reading, however this discretion should be 
exercised on the side of caution. In the event that the participation of a subject in the study is 
delayed and some screening procedures had been performed outside of the prescribed screening 
window, outdated screening procedures may be repeated. 
9.2 
Clinical Visits and Follow-Up 
Each subject will come for a visit to the clinical facility on Days 1 and 29 to be dosed with the 
study vaccine or placebo, according to their assigned randomised treatment.  
Subjects will return on Days 2, 8, 29, 30, 36, and 57 for safety, including clinical laboratory safety, 
and immunological assessments.  
Subjects will return on Days 15 and 43 for immunological assessments only.  
Subjects will also return on Days 2 and 30, and 8 and 36 for a 24-hour and 7-day post-dose 
(respectively) safety assessment only.  
In addition, subjects will be asked to return to the clinic at approximately 6 and 12 months post 
second dose (approximately Days 209 and 394) for a safety follow-up and blood draws for 
assessment of the duration of the immune response to the vaccine. 
Subjects will be asked to return for an adhoc visit in early November where they will be informed 
of findings related to vaccine related HIV diagnostic interference. Subjects will receive written 
and verbal information on the potential for vaccination to elicit a reactive HIV results on some 
diagnostics and assured that this result does NOT indicate a HIV positive result. 
A subset of subjects will also be asked to return at 3 months after their last dose (Day 120) for 
additional immunology assessment to evaluate the duration of HIV diagnostic cross-reactivity 
9.3 
Randomisation and Blinding 
Subjects will be administered either a cohort specific SARS-CoV-2 Sclamp vaccine or placebo 
(Treatment A, B, C, or D, see Section 9.5), according to the randomisation scheme produced by 
Syneos Health. Eligible subjects will be allocated a randomisation number associated with a 
randomised treatment prior to dosing, as close to dosing as feasible (Day 1) in order to minimise 
the number of subject withdrawals in the period between randomisation allocation and dosing.  
The subjects and the clinical personnel involved in the collection, monitoring, revision, or 
evaluation of AEs, or personnel who could have an impact on the outcome of the study will be 
blinded with respect to the subject’s treatment assignment (SARS-CoV-2 Sclamp vaccine or 
placebo). Except for circumstances related to subject safety (see Section 7.1), blinding will be 
maintained at least until data collection of all subjects in each cohort up to Day 57 i.e., when 
reporting and evaluation of all AEs have been completed up to 28 days post-second dose.  

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After data is collected for all subjects up to Day 57 the collected data will be locked and the 
treatment assignment will be unblinded to all study team members for the purpose of data analysis 
and generation of the Clinical Study Report (CSR) Part 1 and Addendum to the CSR Part 2. 
Subjects will remain blinded for the remaining duration of the study, thus the study will adopt a 
single-blind design after Day 57. 
Designated pharmacy personnel at the clinical site not directly involved with the clinical aspects 
of the trial will prepare and dispense the study medication and will be aware of the randomisation 
code and the treatment.  
In the event of an emergency for an individual subject in which knowledge of the study treatment 
is critical to the subject’s medical management, or for the decision of dose escalation, the 
Investigator, or another attending study physician, will break the blind for that subject. An 
envelope for each subject containing their treatment assignment will be available from the 
pharmacy personnel. The Investigator, or other attending study physician, will make every effort 
to contact the Sponsor prior to unblinding a subject’s treatment assignment and will record the 
date and reason for unblinding in the study source documents. In the event the Sponsor cannot be 
contacted prior to unblinding, the Sponsor will be contacted at the earliest feasible time after the 
unblinding has occurred.  
9.4 
Allocation of Subjects to Treatment 
Subjects will be randomly assigned a 4-digit randomisation number beginning by “1”, “2”, “3”, 
“4”, “5” and “6” for Cohorts 1, 2, 3, 4, 5 and 6 respectively. Each subject number corresponds to 
a treatment assignment on the generated randomisation scheme.  
For Part 1 (healthy adults), the two sentinel subjects of each cohort will have the first two subject 
numbers of their cohort e.g. 1001 and 1002 for Cohort 1, and 2001 and 2002 for Cohort 2 and 3001 
and 3002 for Cohort 3. In the case where a subject is replaced (following specifications described 
in Section 9.13), the replacement volunteer will take the same treatment and the same subject 
number added with 100. For example, if the subject number 1001 withdrew, the replacement 
subject will have the subject number 1101, with the treatment planned for the randomization 
number 1001. 
For Part 2 (healthy older adults), subjects will be randomly assigned to treatment groups in a 3:1 
ratio of Active to Placebo. The randomisation will be stratified by age (≥56 to ≤65 years, and ≥ 66 
years respectively). 
For subjects who are replaced, the replacements should take the same treatment assignment as the 
original subject to ensure that the planned treatment allocation ratio is retained. 
9.5 
Study Medication 
Drug Product (DP) will be provided as separate single-use vials containing each, the SARS-CoV-
2 Sclamp antigen (CSIRO Manufacturing, Clayton VIC 3168, Australia). Squalene adjuvant 
material, MF59C.1, will be supplied in pre-filled syringes each containing a total volume of 0.25 
mL (Seqirus). DP and adjuvant will be mixed at the clinical site, and 0.5 mL of the vaccine 

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suspension will be drawn into a syringe for IM injection as the final investigational medicinal 
product (IMP). 
Placebo will be provided in a single-use vial containing sterile saline for injection (Pfizer, 
Mulgrave VIC 3170). 0.5 mL of the placebo will be drawn into a syringe for injection.  
All vaccine and placebo materials will be received and handled while observing aseptic techniques. 
After preparation, the vaccination dose will be transported in a blinding bag placed in a box, and 
unblinded dosers will be used to preserve the blinding, as physical masking of the syringe to 
preserve the blind is not possible. 
Subjects will receive two single IM doses (5, 15, or 45 mcg) of the following 3 study treatments 
at 28 days apart as follows:  
• Treatment A (Cohorts 1 & 4): SARS-CoV-2 Sclamp vaccine 1 x 5 mcg in 0.5 mL 
suspension, or placebo, administered in a two dose regimen at least 28 days apart. 
• Treatment B (Cohorts 2 & 5): SARS-CoV-2 Sclamp vaccine 1 x 15 mcg in 0.5 mL 
suspension, or placebo administered in a two dose regimen at least 28 days apart. 
• Treatment C (Cohorts 3 & 6): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL 
suspension, or placebo administered in a two dose regimen at least 28 days apart. 
• Treatment D (Cohort 3 only): SARS-CoV-2 Sclamp vaccine 1 x 45 mcg in 0.5 mL 
suspension, or placebo administered as a single dose, followed by placebo as the second 
dose, at least 28 days apart. 
• Placebo: 0.5 mL solution (Sterile saline for injection)  
9.6 
Treatment Supplies and Accountability 
It is the responsibility of the Sponsor to ensure that the study vaccine, adjuvant and placebo 
provided for this study are suitable for human use. The active vaccine and placebo products will 
be provided by the Sponsor, packed and labelled in accordance with GMP and Annex 13 
requirements. The Sponsor is responsible for shipping a sufficient amount of dosage units to allow 
the clinical site to maintain an appropriate sampling for the study, according to TGA regulation. 
Study medication will be stored at the clinical site as per applicable requirements. SARS-CoV-2 
Sclamp antigen will be stored in a locked, environmentally-controlled medication room (at 2-8 °C) 
with restricted access, and the MF59C.1adjuvant will be stored in a locked, enviromentally-
controlled medication room (at 2-8 °C) with restricted access. The individual dosage units and 
outer container(s) will bear a label containing at least the name of the study treatment, lot and/or 
batch number, and manufacturing and/or expiry/retest date. The management of investigational 
vaccines is under the supervision of the Investigator. 
Individual doses for each subject and period will be dispensed at the clinical site, as per the 
appropriate local SOP. Individual doses will be dispensed according to the randomization scheme 
in appropriate containers indicated with at least the project number and the subject number. 
Whenever possible, dispensing and study treatment administration should be conducted within 3 

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hours of preparation of each dose, which will be stored at ambient temperature in a locked 
medication room prior to use. If stored refrigerated, syringes must be allowed to acclimatise to 
room temperature for at least 10 minutes prior to use. 
All study vaccine materials received at the clinical site will be inventoried and accounted for 
throughout the study, and the result recorded in the drug accountability/retention record according 
to the clinical site appropriate SOP. Upon completion of the study, the remaining test and reference 
products will be maintained at the clinical site, discarded or returned to the Sponsor, as per 
Sponsor's request. 
9.7 
Study Treatment Administration 
The study vaccine, or placebo, will be administered to the deltoid region of the subjects 
non-dominant arm(or deltoid region of other arm should a tattoo be present) via IM injection 
observing aseptic techniques. Detailed instructions for study vaccine administration will be 
included in the pharmacy manual. 
Prior to treatment administration, subjects must be determined to be eligible for study vaccination 
and it must be clinically appropriate in the judgement of the Investigator, or another attending 
study physician, to vaccinate. Eligibility for study treatment administration prior to first 
administration is determined by evaluating the eligibility criteria outlined in Sections 8.3 and 8.4. 
For second dosing (Day 29), subjects who may fall outside of the bounds of eligibility criteria may 
still be dosed if it is deemed safe to continue in the opinion of the Investigator, or other attending 
study physician.Those subjects who fall outside the bounds of eligibility and who are not dosed 
will be withdrawn from the study and the reason for discontinuance documented.  
Standard immunisation practices are to be observed, and care should be taken to administer the 
injection intramuscularly. Before administering vaccine, the vaccination site is to be disinfected 
with an appropriate skin disinfectant (e.g. 70% alcohol) and allowed to dry. 
As with all injectable vaccines, trained medical personnel and appropriate medical interventions 
should be readily available in case of anaphylactic reactions following vaccine administration e.g. 
adrenaline (epinephrine), diphenhydramine, and/or other medications for treating anaphylaxis 
should be available). 
The time of injection of each subject will be recorded in the source documents. Time of dosing 
will be set as the time of start of injection. 
9.8 
Study Restrictions 
9.8.1 Food and Fluids 
No food or fluid intake restrictions will be in place for the duration of the study. 

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9.8.2 
Tobacco, Alcohol, and Illicit Drugs 
Subjects will be required to abstain from using soft or hard drugs from screening and throughout 
the study or any tobacco or nicotine products from at least 2 hours prior to each dosing until 4 hours 
post-dose. Subjects will be required to abstain from food containing poppy seeds within 24 hours 
prior to each treatment administration. 
Consumption of alcohol-based products will be prohibited from 24 hours prior to each visit on 
Days 1, 2, 8, 15, 29, 30, 36, 43, 57, 209, and 394. 
9.8.3 Prior and Concomitant Medications 
Subjects will be required to avoid using excluded prescription, over-the-counter (OTC) (other than 
those specified in the protocol), immunosuppressant treatments and related coronavirus vaccines 
i.e. SARS-CoV-1, SARS-CoV-2, MERS-CoV etc. for the periods of time specified in exclusion 
criterion #11 and throughout the study.  
All medications and vaccinations taken by subjects after screening until the last study day will be 
documented as concomitant medications. Concomitant medications will be documented by 
treatment group, therapeutic area, and preferred drug name. Additionally, prior medical history of 
vaccinations, especially recent history of immunization boosters or influenza vaccinations, may be 
categorized as concomitant medications. If it is unclear whether a subject’s use of medication is to 
be classified as a prior or concomitant medication i.e. falling within the screening period or periods 
of time specified in exclusion criterion #11, it is to be assumed that its use is concomitant. 
Medications will be coded using the WHO Drug dictionary, and a listing will be presented for all 
concomitant medication data for all subjects. 
9.8.4 Posture and Physical Activity 
Subjects will be allowed to engage in normal activity. 
9.9 
Sample Collection and Processing 
Over the course of the study, a blood sample will be collected at each visit (total of no more than 
36 blood samples from each subject) for screening, safety laboratory and immunological 
assessments. Sample volume collected will vary between 15 mL and a maximum of 73 mL with 
individual samples collected into multiple tubes to facilitate disparate immunological tests (see 
table below for details). 
A total of 8 blood samples will be collected for safety laboratory assessments from each subject, 
one sample at screening, pre-dose (within 60 minutes pre-dose), and 1, 7, and 14 days post dose 
for each dose (Days 1, 2, 8, 29, 30, 36). Each sample will consist of 15 mL of whole blood.  
PD samples collected for immunogenicity assessment will 4 mL for T-cell analysis, 10 mL for 
ELISA, Luminex assay, virus neutralisation assay, and ADCC analysis, and 20 mL for isolation 
and cryopreservation of PBMCs. Pre-dose samples should be taken within 60 minutes of dosing, 
but all other samples may be taken within the visit window specified in Section 9.2.  

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Sample collections performed outside the pre-defined time windows are protocol deviations, 
however will be used for immunological, safety and statistical analyses. Unless otherwise 
specified, or for subject safety, when blood draws and other procedures coincide, blood draws will 
have precedence. Blood samples will be collected by direct venipuncture. 
The total volume of blood including that collected for eligibility screening and safety purposes 
should not exceed 500 mL for the whole study, with up to 400 mL collected at visits between Day 
1 and Day 57±2, and up to 100 mL collected at the Day 209±5 and 394±5 visits. All blood samples 
will be collected and processed as per the supplementary study specific laboratory manuals. 
Table 1: Summary of all blood samples collected over the study Part 1 (Cohorts 1-3) 
 
Visit 
Total 
Collection 
Volume 
(mL) 
Number of Samples Collected and Purpose of Sample 
Safety Lab 
(15 mL) 
  PD  
(3-4 ml 
Whole blood) 
PD 
(8-10 mL 
Serum) 
PD  
10-20 mL 
PBMCs) 
Screening 
29 
1 
1 
1 
0 
Day 1 (first dose) 
63 
1 
2 
2 
1 
Day 2 
15 
1 
0 
0 
0 
Day 8 
39 
1 
1 
0 
1 
Day 15 
34 
0 
1 
1 
1 
Day 29 (second dose) 
49 
1 
1 
1 
1 
Day 30 
15 
1 
0 
0 
0 
Day 36 
43 
1 
2 
0 
1 
Day 43 
34 
0 
1 
1 
1 
Day 57 
59 
1 
1 
2 
1 
Day 120 
10 
0 
0 
1 
0 
Day 209 
40 
0 
0 
2 
1 
Day 394 
20 
0 
0 
2 
0 
Total volume 
450 
 
 
Table 2: Summary of all blood samples collected over the study Part 2 (Cohorts 4-6) 
 
Visit 
Total 
Collection 
Volume 
(mL) 
Number of Samples Collected and Purpose of Sample 
Safety Lab 
(15 mL) 
  PD  
(3-4 ml 
Whole blood) 
PD 
(8-10 mL 
Serum) 
PD  
10-20 mL 
PBMCs) 
Screening 
25 
1 
0 
1 
0 
Day 1 (first dose) 
63 
1 
2 
2 
1 
Day 2 
15 
1 
0 
0 
0 
Day 8 
39 
1 
1 
0 
1 
Day 15 
34 
0 
1 
1 
1 
Day 29 (second dose) 
45 
1 
0 
1 
1 
Day 30 
15 
1 
0 
0 
0 
Day 36 
39 
1 
1 
0 
1 
Day 43 
34 
0 
1 
1 
1 
Day 57 
55 
1 
0 
2 
1 
Day 209 
30 
0 
0 
1 
1 
Day 394 
10 
0 
0 
1 
0 
Total volume 
404 
 

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9.9.1 Samples Storage 
Samples collected for safety assessments will be retained by the central laboratory for 60 days 
after which they will be destroyed. 
 
Samples collected for immunogenicity analysis will be retained by the bioanalytical labs for a 
maximum of 15 years after the study completion date.  
 
9.10 Subject Monitoring 
Subjects will be monitored throughout the study by the clinical staff for adverse events. A 
physician will be on site for treatment administration and until at least 2 hours post-dose, and 
available on call for the remainder of the study. If necessary, a physician, either at the clinical site 
or in a nearby hospital will administer treatment for any adverse event(s). A crash cart or 
emergency bag containing the necessary rescue material and appropriate medications will be 
available in the clinic to allow rapid intervention in case of emergency. 
Subjects will be closely monitored by a medical team in the hours following dosing for the 
presence of symptoms of allergic or hypersensitivity reactions. Subjects will be also encouraged 
to quickly report any symptoms at any time they occur during the study period. The necessary 
rescue material, equipment, and appropriate medications will be available in the in the clinic to 
allow rapid intervention in case of emergency including, but not limited to: 
• Oxygen; 
• Adrenaline 1:1000 solution for IV or endotracheal injection; 
• Antihistamines; 
• Corticosteroids; and 
• IV infusion solutions, tubing, catheters, and tape. 
The following procedures will be followed in the event of a suspected anaphylactic reaction after 
dosing: 
• Maintain an adequate airway. 
• Administer antihistamines, adrenaline (epinephrine), or other medications as required by 
patient status and directed by the PI or a Medical Sub-Investigator. 
• Continue to observe the patient and document observations. 
• Emergency medical services may be called as needed. 
Safety parameters, including laboratory results and ECG, will be assessed by a physician, using 
the clinical site's criteria for biomedical laboratory and ECG acceptance ranges as suggested 
guidelines in making the medical assessment. Abnormal safety laboratory results will be graded 
as mild, moderate or severe. 

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Scheduled safety measurements will be repeated according to the clinical site SOPs or upon request 
from a physician. Any abnormal repeated measurement will be evaluated by a physician and 
repeated if judged necessary. Further action may be taken upon physician's request. 
Subjects will be advised to notify their health care professional(s) (e.g., physician, dentist, and/or 
pharmacist) that they are participating in a clinical research study on a treatment called SARS-
CoV-2 Sclamp Vaccine, which is being developed for potential clinical use in the prevention of 
COVID-19 before taking any medicines or undergoing any medical procedure. 
9.10.1 Vital Signs 
BP, HR, RR, TT, and SpO2 will be measured in a sitting position (except for safety reasons), at 
screening, pre-dose (each dose, Days 1 and 29), 24 hours post-dose (each dose, Days 2 and 30). 
Vital signs measurements should be performed before the blood collection whenever possible. 
Subjects should be seated for at least 5 minutes prior to taking measurements to allow for 
acclimatisation. 
9.10.2 ECG 
ECG will be performed at screening, before dosing (each dose, Days 1 and 29), and approximately 
24 hours post-dose (each dose, Days 2 and 30). Subjects should recline in supine position for at 
least 5 minutes prior to taking measurements to allow for acclimatisation. 
9.10.3 Physical Examination  
 A complete physical examination will be performed at screening. A complete physical 
examination includes assessments of the following: head, eyes, ears, nose, throat (HEENT), neck, 
chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and 
general neurological examination. 
A brief physical examination will be done at pre-dose (each dose, Days 1 and 29). A brief physical 
examination includes assessments of the following: HEENT, chest, lungs, abdomen, 
dermatological, cardiovascular/peripheral vascular, and areas of note elicited from the subject.  
9.10.4 Drug and Alcohol Screen 
A urine drug screen (amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, 
cocaine, opiates, MDMA, PCP, and THC) and an alcohol breath test will be performed at screening 
and prior to each dosing. 
9.10.5 Pregnancy Test 
Where applicable i.e. for WOCBP, a serum pregnancy test will be performed at screening, and a 
urine pregnancy test will be performed pre-dose (each dose, Days 1 and 29). Where a positive 
urine pregnancy test is returned on Days 1 or 29, a serum pregnancy test will be undertaken for 
confirmation. 

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9.10.6 Laboratory Assessments 
9.10.6.1 
Tolerable Windows 
Assessment value ranges, including those pertaining to haematology, biochemistry, coagulation, 
serology, and urinalysis are defined in Section 9.15.2. Subjects with values outside of these 
tolerable ranges will be assessed on a case-by-case basis by the PI to determine if follow-up is 
required for safety reasons. 
To accommodate the various assessments a time window of ±1 hour and ±30 minutes will be 
allowed for pre and post-dose assessments respectively. Where applicable, blood collections will 
be prioritised ahead of other assessments (with an exception for vital signs, described in 
Section 9.10.1).  
9.10.6.2 
Haematology 
Haematology will be performed at screening, before dosing (each dose, Days 1 and 29±2), 
approximately 24 hours after each dosing(Day 2, Day 30±1), Day 8±1,  Day 36±2, Day 57±2. The 
following will be assessed: haemoglobin, haematocrit, RBC count, WBC count, neutrophils, 
lymphocytes, monocytes, eosinophils, basophils, platelet count. 
9.10.6.3 
Biochemistry 
Biochemistry will be performed at screening, before dosing (each dose, Days 1 and 29±2), 
approximately 24 hours after each dosing(Day 2, Day 30±1), Day 8±1, Day 36±2, Day 57±2. The 
following will be assessed: albumin, amylase, lipase, creatine kinase, cholesterol, alkaline 
phosphatase, AST, ALT, GGT, urea, calcium, glucose random, magnesium, phosphate, potassium, 
creatinine, sodium, total bilirubin, LD, total protein, serum pregnancy (at screening and 
confirmation if a positive urine pregnancy test is returned on Days 1 and 29±2), urine pregnancy 
Days 1 and 29±2,  and FSH (at screening only). 
9.10.6.4 
Coagulation 
Coagulation tests will be performed at screening, before dosing (each dose, Days 1 and 29±2), 
approximately 24 hours after dosing(Day 2, Day 30±1), Days 8±1, 36±2, and 57±2. The following 
will be assessed: prothrombin time (PT), partial prothrombin time (APTT), and fibrinogen. 
9.10.6.5 
Serology 
Serology will be performed at screening. The following will be assessed: HIV 1 /2 and P24  antigen 
and antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. 
9.10.6.6 
Urinalysis 
Urinalysis will be performed at screening, before dosing (each dose, Days 1 and 29±2), 
approximately 24 hours after each dosing(Day 2, Day 30±1), Day 8±1, Day 36±2, Day 57±2. The 

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following will be assessed: microscopic examination, pH, specific gravity, protein, glucose, 
ketones, bilirubin, occult blood, nitrite, urobilinogen, and leukocytes.  
9.10.6.7 
SARS –CoV-2 Test 
A SARS-CoV-2 test (nasal/oropharyngeal swab and RT-PCR and serum antibodies by ELISA) 
will be performed at screening, and Days 1  29 (nasal/oropharyngeal swab and RT-PCR only) and 
may also be performed on an ad hoc basis for subjects displaying, or reporting, symptoms 
characteristic of COVID-19 i.e. fever, dry cough, shortness of breath etc. at any time up to day 
394. 
9.10.7 Subject Self-Reporting 
Subject self-reporting will occur throughout the study and will involve subjects being provided 
with access to an electronic diary(eDiary), or paper diary card(Diary), an oral thermometer, and a 
transparent, circular measuring device to provide safety information during periods when the 
subject is not present at the clinical site.  
The electronic diary will be used from the time of first dose (Day 1) to 28 days post-second dose 
(Day 57±2), but may also be used during the 12 month follow-up period (up to Day 394±5) on an 
ad hoc basis if safety events arise. Subjects are required to complete daily reporting of solicited 
adverse events from Day 1 to Day 8, and Day 29 to Day 36. Subjects will use the diary to report 
spontaneous adverse events, concomitant medication use, doctor visits, and the COVID-19 
symptoms as these events arise during study participation. 
The oral thermometer will be used to provide subjects oral temperature, and the transparent, 
circular measuring device will be used to measure any local reactogenicity events i.e. redness, 
swelling etc. arising around the injection site. Training for the use of the oral thermometer and 
measuring device, as well as the electronic diary, will be provided on Day 1 following dosing.  
When measuring oral temperature, subjects will be required to abstain from eating or drinking hot 
or cold foods and drinks for 30 minutes prior to each reading. 
Examples of information captured via self-reporting will include both local (pain, swelling, 
redness etc.) and systemic events (fever, nausea, diarrhoea, fatigue, headache , muscle aches), as 
well as a prompt for symptoms of COVID-19, or potential recent exposure to SARS-CoV-2, or 
acquaintances diagnosed with COVID-19. 
9.10.8 Injection Site Examination 
An injection site examination will be performed at screening, pre-dose (each dose, Days 1 and 29), 
30 minutes, and 24 hours post-dose (each dose, Days 2 and 30) to document the  appearance. 
Subjects will be provided instructions on how to self-assess at home daily (from Days 1-8 and 29-
36). An injection site examination site at screening will consist of examining the injection site 
(deltoid area of the subjects non-dominant arm), and making note of any skin reactions, 
disturbances, tattoos (on the deltoid area of the arm), or discolourations, for subject eligibility 
purposes. An injection site examination pre-dose will consist of examining the injection site and 
making note of the presence of any skin reactions, disturbances, or discolourations to establish a 

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baseline for assessment. An injection site examination post-dose will consist of examining the 
injection site and making note of the presence of any skin reactions, disturbances, or 
discolourations, such that they may be compared to the pre-dose examination. For each dose at 
pre-dose, 30 minutes, 24 hours, and 7 days post-dose, a trained observer, whom is blinded to the 
randomization scheme, will check and, as appropriate, record any local dermal reactions at the 
application site of note and review the eDiary/Diary with the subject.. When possible, the same 
evaluator will follow the subject throughout the study. In the event that more than one evaluator is 
required to follow the subject throughout the study, then every precaution should be taken to limit 
the number of evaluators. 
9.11 Study Exit Procedures 
Blood draws for immunogenicity assessments, and AE monitoring will be performed on the last 
study day (Day 394±5). In the event of discontinuance of a study subject leading to withdrawal 
from the study, all efforts will be made to complete study exit procedures within 14 days after the 
last participation of the subject in the study. 
9.12 Data Collection and Evaluation 
The clinical study site will use a validated EDC system to enter subject data onto electronic case 
report forms (eCRFs). Data will be collected using the EDC system and entered into a quality 
controlled clinical database. Prior to the commencement of the study, items to be included in the 
clinical database will be determined, and suitable paper source documents will be created to ensure 
the appropriate collection of all required data. 
Clinical staff conducting the study will enter the required data promptly, accurately, legibly, and 
indelibly onto source documents. All entries, corrections, and alterations will be made by the 
Investigator or other authorized study personnel, and all data entries will be verified for accuracy 
and correctness. The EDC system is optimized for manual keying and review (including review 
by independent monitors) and maintains a full audit trail. All source documents will be conserved 
in order to maintain data integrity. 
Clinical laboratory, PD, safety, and/or immunogenicity data will be transmitted electronically from 
external vendors to Data Management and reconciled against the clinical database. Further details 
of data management processes will be detailed in the data management plan. 
9.13 Subject Withdrawal and Replacement 
Subjects will be advised that they are free to withdraw from the study at any time. Over the course 
of the study, the Sponsor and the Investigator or a delegate may withdraw any subject from the 
study for one of the reasons described below; subject withdrawal will be done in accordance with 
the clinical site’s SOP: 
• Safety reason; 
• Non-compliance with protocol requirements; 
• Significant protocol deviation; or 

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• Positive alcohol breath test, urine drug screen, or pregnancy test; 
Haematology, coagulation, and biochemistry results will be reviewed by the Investigator prior to 
dosing; subjects will be withdrawn from the study if it is deemed that the subject’s safety may be 
at risk on the basis of these test results. 
Subjects who withdraw, or are withdrawn, from the study prior to dosing, but after randomization, 
may be replaced. Subjects who withdraw, or are withdrawn, from the study after dosing will not 
be replaced. However, in the event that individual subjects drop out early into the study or the 
number of drop-outs exceeds initial expectations, subjects who withdraw, or are withdrawn, may 
be replaced at the discretion of the Sponsor. Such replacement resulting in dosing more subjects 
than planned in this protocol would be documented in a protocol amendment. 
Subjects who withdraw, or are withdrawn, will be asked to remain at the clinic until the 
Investigator or a delegate agrees that the subject is fine and can be discharged. As soon as subject 
withdrawal is confirmed, blood sampling will be stopped. A PD blood draw may be collected at 
the time of withdrawal if deemed required by the Investigator. Study exit procedures will be 
performed at the time of withdrawal from the study, or as soon as possible thereafter.  
9.14 Early Termination Visit 
In the event that a subject withdraws, or is withdrawn, from the study, the PI will notify the Sponsor 
and, when possible, will invite the subject to return to the clinical site for an early termination visit. 
When applicable, the visit will include the procedures listed below: 
• Review the subject’s solicited and unsolicited safety data; 
• Perform an injection site inspection (if terminated within the reactogenicity reporting 
period for either dose); 
• Review of concomitant medications/vaccinations since last visit; and 
• Draw blood samples for safety laboratory and immunogenicity assessments; 
9.15 Adverse Events 
9.15.1 Definition of Adverse Events 
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study 
or, if present at screening, worsens during the study, regardless of the suspected cause of the event. 
All medical and psychiatric conditions (except those related to the indication under study) present 
at screening will be documented in the medical history eCRF. Changes in these conditions and 
new symptoms, physical signs, syndromes, or diseases should be noted on the AE eCRF during 
the rest of the study. Clinically significant laboratory abnormalities should also be recorded as 
AEs. Surgical procedures that were planned before the subject enrolled in the study are not 
considered AEs if the conditions were known before study inclusion; the medical condition should 
be reported in the subject’s medical history. 

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Adverse events are collected as either solicited or unsolicited AEs. Solicited events are those 
collected in the eDiary Study Symptoms Form, which subjects are prompted to enter daily for 7 
days following each vaccinaton. Unsolicited AEs are those that are reported spontaneously by the 
subject, either in the eDiary Adverse Events form, during a study visit, or by contacting the study 
site between visits. 
Any vital sign abnormality that is judged to be clinically significant by the investigator must be 
recorded as an AE. 
Any abnormal laboratory test finding that is judged by the investigator as clinically significant 
must be recorded as an AE or an SAE, if it meets the definition of an SAE (Section 9.15.3). 
9.15.2 Recording of Adverse Events 
Adverse events will be recorded and evaluated for their seriousness, severity, and relationship to 
the study medication. Adverse events will be collected and documented during the course of the 
study by appropriately trained and delegated medical staff in the clinic, as well as via self-reporting 
from subjects using the electronic diary. For a period of 12 months following the last study vaccine 
administration, adverse events will also be documented, if reported. Adverse events will be 
followed-up until complete resolution, or until the Investigator judges it to be safe to discontinue 
follow-up.  
The term “reactogenicity” refers to solicited signs and symptoms (“solicited AEs”) occurring in 
the hours and days following vaccination, to be collected by the subject or legal representative(s) 
for 7 consecutive days, using an electronic Diary (eDiary) or paper Diary card (Diary). 
The following solicited local and systemic AEs are included in the e-Diary. Solicited local 
reactions include erythema, swelling, and pain at the injection site. Solicited systemic reactions 
include fatigue, fever, headache, myalgia/arthralgia, chills, diarrhoea, nausea/vomiting. 
Upon review of the subject ediary, if a solicited local or systemic AE has been reported with a 
severity Grade=3 (severe), then the site is to confirm with the subject whether medical assistance 
was sought, was concomitant medication taken, and collect information around the event and 
outcome to document a safety assessment. In the event that the additional information leads to a 
determination that the solicited AE is deemed a Serious Adverse Event (SAE), the site will record 
the solicited AE as an SAE and report the event following the SAE reporting guidelines and time 
frames. 
Each solicited AE is to be assessed using the toxicity grading provided in the scoring system 
adapted from the FDA Guidance for Industry -Toxicity Grading Scale for Healthy Adults and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.4 Solicited AEs will be 
recorded as mild, moderate or severe by study subjects. 
 
 

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Table 2. 
Toxicity Grading for Solicited Local (Administration Site) Adverse 
Events 
Local Reactions to 
Injection 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Pain (at the vaccination 
site) 
Does not interfere with 
activity 
Repeated use of 
non-narcotic pain reliever 
>24 hours or interferes 
with activity 
Any use of narcotic pain 
reliever or prevents daily 
activity 
Tenderness 
Mild discomfort to touch 
Discomfort with 
movement 
Significant discomfort at 
rest 
Erythema/Redness 
2.5 – 5 cm 
5.1 – 10 cm 
>10 cm 
Induration/Swelling 
2.5 – 5 cm and does not 
interfere with activity 
5.1 – 10 cm or interferes 
with activity 
>10 cm or prevents daily 
activity 
 
Table 3. 
Toxicity Grading Scales for Solicited Systemic Adverse Events 
Systemic Solicited 
Adverse Event 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Fever °C 
(Oral*) 
 
38.0 – 38.4 
. 
38.5 – 38.9 
39.0 - 40 
Chills 
Present, but does not 
interfere with activity 
Interferes with activity 
Prevents daily activity 
Nausea 
Nausea present but not 
interfering with daily 
activity 
Nausea present 
leading to decreased 
oral intake 
Nausea present leading 
to minimal to no oral 
intake 
Vomiting 
No interference 
with activity or 1 – 2 
episodes in 24 hours 
Some interference 
with activity or >2 
episodes in 24 hours 
Prevents daily activity, 
≥4 episodes in 24 
hours, or 2 or more per 
day prolonged on 
several days 
Muscle pain 
Present, but does not 
interfere with activity 
Interferes with activity, 
or some use of non- 
narcotic pain 
reliever 
Prevents daily activity; 
use of narcotic pain 
reliever 
Joint pain 
Present, but does not 
interfere with activity 
Interferes with activity, 
or some use of non- 
narcotic pain 
reliever 
Prevents daily activity; 
use of narcotic pain 
reliever 
Headache 
Present, but does not 
interfere with activity 
Interferes with activity, 
or some use of non- 
narcotic pain 
reliever 
Prevents daily activity; 
use of narcotic pain 
reliever 

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Systemic Solicited 
Adverse Event 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Fatigue/Somnolence 
Present, but does not 
interfere with activity 
Interferes with activity, 
Prevents daily activity; 
Diarrhoea 
2 – 3 loose stools or 
<400 g / 24 hours 
4 – 5 stools or 
400 – 800 g / 24 
hours 
6 or more watery stools 
or 
>800 g / 24 hours or 
requires outpatient IV 
hydration 
Malaise (general 
discomfort) 
No interference with 
activity 
Some interference with 
usual and social activity, 
no treatment 
Significant, prevents 
usual daily and social, 
activity or requires 
treatment 
* Oral temperature; no recent hot or cold beverages or smoking 
 
Subjects will be instructed to report the local and systemic solicited AEs in the electronic Diary 
(eDiary)/Diary card on a daily basis, preferably about the same time each day. The eDiary/Diary 
card will be reviewed and the subject interviewed by the investigator or designee at each study 
visit regarding the AEs. All AEs are to be followed up until resolution or a stable clinical endpoint 
is reached. Any solicited AE that meets the following criteria must be entered into the Adverse 
Event eCRF: 
• Solicited local or systemic AEs leading to a subject withdrawing or being 
withdrawn from the study by the PI, 
• Solicited local or systemic AEs that last beyond 7 days duration, 
• Solicited local or systemic AEs that lead to the decision not to further vaccinate a 
subject, 
• Solicited local or systemic AEs that meet the definition of an SAE. 
Each AE is to be documented in the eCRF with reference to date of onset, duration, frequency, 
severity, relationship to study treatment, action taken with study treatment, treatment of event, and 
outcome. Furthermore, each AE is to be classified as being serious or non-serious. Changes in AEs 
and resolution dates are to be documented on the eCRF. 
For the purposes of this study, the period of observation for collection of AEs extends from the 
time the subject gives informed consent until the last follow-up visit (Day 394). Follow-up of the 
AE, even after the date of therapy discontinuation, is required if the AE persists until the event 
resolves or stabilizes at a level acceptable to the investigator. An AE that occurs in the period from 
informed consent until vaccination is a non-treatment emergent AE. An AE that occurs in the 
period from vaccination until study exit is a Treatment Emergent AE (TEAE).  

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When changes in the intensity of an AE occur more frequently than once a day, the maximum 
intensity for the event should be noted. If the intensity category changes over a number of days, 
then those changes should be recorded separately (with distinct onset dates). 
Specific guidelines for classifying AEs by intensity and relationship to study drug are given in 
Table 4 and Table 5. 
 
Table 4. 
Classification of Adverse Events by Intensity 
 
MILD: An event that is easily tolerated by the subject, causing minimal discomfort and not 
interfering with everyday activities. 
MODERATE: An event that is sufficiently discomforting to interfere with normal everyday 
activities. 
SEVERE: An event that prevents normal everyday activities. 
 
Table 5. 
Classification of Adverse Events by Relationship to Study Vaccine 
 
UNRELATED: This category applies to those AEs that are clearly and incontrovertibly due to 
extraneous causes (disease, environment, etc.) 
UNLIKELY:  This category applies to those AEs that are judged to be unrelated to the test vaccine 
but for which no extraneous cause may be found. An AE may be considered unlikely to be related to 
study vaccine if or when it meets 2 of the following criteria: (1) it does not follow a reasonable temporal 
sequence from administration of the test vaccine; (2) it could readily have been produced by the 
subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the 
subject; (3) it does not follow a known pattern of response to the test vaccine; or (4) it does not reappear 
or worsen when the study vaccine is readministered. 
POSSIBLY: This category applies to those AEs for which a connection with the test vaccine 
administration appears unlikely but cannot be ruled out with certainty. An AE may be considered 
possibly related if or when it meets 2 of the following criteria: (1) it follows a reasonable temporal 
sequence from administration of the vaccine; (2) it could not readily have been produced by the 
subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the 
subject; or (3) it follows a known pattern of response to the test vaccine. 
PROBABLY:  This category applies to those AEs that the investigator feels with a high degree of 
certainty are related to the test vaccine. An AE may be considered probably related if or when it meets 
3 of the following criteria: (1) it follows a reasonable temporal sequence from administration of the 
vaccine; (2) it could not be reasonably explained by the known characteristics of the subject’s clinical 
state, environmental or toxic factors, or other modes of therapy administered to the subject; (3) it 
disappears or decreases on cessation or reduction in dose (note that there are exceptions when an AE 
does not disappear upon discontinuation of the vaccine, yet treatment-relatedness clearly exists; for 
example, as in bone marrow depression, fixed drug eruptions, or tardive dyskinesia); or (4) it follows a 
known pattern of response to the test vaccine. 
Abbreviation: AE = adverse event. 

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9.15.2.1 
Unsolicited Adverse Events 
An unsolicited AE is an AE that was not solicited using the subject’s eDiary and that was 
spontaneously reported by a subject. Unsolicited AEs include serious and non-serious AEs. 
 
9.15.2.2 
Medically-Attended Events and Significant New Medical Conditions 
Potentially unsolicited AEs may be medically attended. The subjects will be instructed to contact 
the site as soon as possible to report any Medically Attended AE (MAAE) or significant new 
medical condition (SNMC). Details about all unsolicited AEs will be collected by qualified study 
personnel, reviewed by the investigator and documented in the subject’s source document. 
The subject e-diary will include prompts for symptoms of respiratory disease that could be 
COVID-19 (table below), to encourage subjects to contact the site or their medical practitioner for 
a confirmatory COVID-19 laboratory test (see Section 9.10.6.7).  
Table 6:  COVID-19 Symptoms Prompt 
Systemic Solicited Adverse Event 
Fever ≥37.5°C 
(Oral*) 
Or history of fever eg. Night sweats, chills 
Cough 
Sore throat 
Shortness of Breath 
* Oral temperature; no recent hot or cold beverages or smoking 
In the event that a laboratory confirmation of COVID-19 is not undertaken and a diagnosis of 
COVID-19 is suspect, a tool to aid diagnosis of COVID-19 in subjects is included in Appendix I 
Checklist for Medical History Follow-Up for Persons Who Meet the Protocol Defined COVID-19 
Case Definition. Study personnel will follow-up to assess the medical history against the COVID-
19 diagnostic categories, signs and symptoms that meet the COVID-19 case definition as per 
Appendix I. 
9.15.3 Serious Adverse Events 
A serious AE (SAE) is any untoward medical occurrence, in the view of either the investigator or 
Sponsor, that: 
• Results in death; 
• Is life-threatening; 
• Results in inpatient hospitalization or prolongation of existing hospitalization; 

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• Results in persistent or significant disability/incapacity; and/or 
• Is a congenital anomaly/birth defect. 
Other important medical events that may not be immediately life-threatening or result in death or 
hospitalization, based upon appropriate medical judgment, are considered serious AEs (SAEs) if 
they are thought to jeopardize the subject and/or require medical or surgical intervention to prevent 
one of the outcomes defining an SAE. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, 
or convulsions that do not result in in-patient hospitalization. Events which could have led to the 
above outcomes had they occurred with greater severity are not SAEs, but should be reported as 
AEs, MAAEs, or SNMCs, as appropriate. 
Serious AEs are critically important for the identification of significant safety problems; therefore, 
it is important to take into account both the investigator’s and the Sponsor’s assessment. If either 
the Sponsor or the investigator believes that an event is serious, the event must be considered 
serious and evaluated by the Sponsor for expedited reporting. 
Any serious adverse event (SAE) will be reported to the Sponsor via telephone, fax, e-mail, or in 
person, within 24 hours of occurrence or knowledge by the Investigator or designee. The 
notification must be directed to: 
Syneos Health Safety and Pharmacovigilance 
Fax Number: 001-877-464-7787 
Local Toll-Free Fax Number Australia: 1800 256 952 
Email: safetyreporting@syneoshealth.com 
Information on SAEs will be recorded on the SAE Report Form. Blank copies are included in the 
study Investigator’s file. It is not acceptable for the Investigator to send photocopies of the patient’s 
medical records to the Sponsor company or its representative in lieu of completion of the 
appropriate AE eCRF page or SAE Report Form. However, there may be instances when copies 
of medical records for certain cases are requested by the Sponsor or its representative. In this 
instance, all subject identifiers will be blinded on the copies of the medical records before 
submission to the Sponsor or its representative.  
The completed SAE Form and SAE cover sheet should be sent via fax or e-mail immediately upon 
completion to Syneos Health Safety and Pharmacovigilance. If the Investigator does not have all 
information regarding an SAE, they will not wait to receive additional information before 
completing and sending the form.  
Additional relevant information or clinical follow-up should be sent via fax or e-mail to Syneos 
Health Safety and Pharmacovigilance as soon as it becomes available. The Investigator should 
follow the subject with the event until resolution or stabilization of the condition. Follow-up 
reports (as many as required) should be completed and faxed/e-mailed following the same 
procedure above.  

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A final report is required once the condition is resolved or stabilized and no more information 
about the event is expected. The final report should be completed and faxed/e-mailed following 
the same procedure above.  
The Investigator must keep a copy of all documentation related to the event in the study site’s files.  
If the Investigator learns of any SAE, including death, at any other time after a subject completes 
the study, and they consider the event reasonably related to the study drug, the Investigator will 
promptly notify the Sponsor/Medical Monitor. 
9.15.4 Suspected Unexpected Serious Adverse Reactions 
AEs that meet all of the following criteria will be classified as suspected unexpected serious 
adverse reactions (SUSARs) and reported to the appropriate regulatory authorities in accordance 
with applicable regulatory requirements for expedited reporting: 
• Serious; 
• Unexpected (i.e., the event is not consistent with the safety information in the IB); or 
• There is at least a reasonable possibility that there is a causal relationship between the event 
and the study treatment 
The investigator will assess whether an event is causally related to study treatment. The Sponsor 
(or Syneos Health) will consider the investigator’s assessment and determine whether the event 
meets the criteria for being reportable as a 7-day or 15-day safety report. SUSARs that are fatal or 
life-threatening must be reported to the regulatory authorities and the HREC(where required) 
within 7 days after the Sponsor (or Syneos Health) has first knowledge of them, with a follow-up 
report submitted within a further 8 calendar days. Other SUSARs must be reported to the relevant 
regulatory authorities and the HREC within 15 calendar days after the Sponsor (or Syneos Health) 
first has knowledge of them. 
The Sponsor (or Syneos Health) is responsible for reporting SUSARs and any other events required 
to be reported in an expedited manner to the regulatory authorities and for informing investigators 
of reportable events, in compliance with applicable regulatory requirements within specific 
timeframes. Investigators will notify the relevant HREC of reportable events within the applicable 
timeframes. 
9.16 Pregnancy 
In the event a dosed female subject (or the female partner of a dosed male subject) becomes 
pregnant during or shortly after participation in the study, this pregnancy will be reported to the 
Sponsor within 24 hours of first knowledge of the event. Any subject who becomes pregnant 
during the study will be immediately withdrawn. Follow-up information regarding the course and 
outcome of the pregnancy will be documented (after obtaining the consent of the female partner, 
when applicable) as per clinical site’s SOP. If the outcome of the pregnancy meets the criteria for 
classification as an SAE, reporting of the event to the HREC and regulatory agency(ies) will be 
performed as per clinical site’s SOP. 

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Any pregnancy will be reported to the Sponsor via telephone, fax, e-mail, or in person, within 
24 hours of knowledge by the Investigator or designee. The notification must be directed to: 
Syneos Health Safety and Pharmacovigilance 
Fax Number: 001-877-464-7787 
Local Toll-Free Fax Number Australia: 1800 256 952 
Email: safetyreporting@syneoshealth.com 
Information on the pregnancy will be recorded on the Pregnancy Report Form. 
9.17 Reportable Disease 
In the case a subject has, or manifests, any clinical signs characteristic of a reportable disease or 
condition (e.g., HIV, tuberculosis, SARS, COVID-19), it is the responsibility of the Principal 
Investigator to notify the Sponsor after becoming aware of the information. 
9.18 Premature Termination of the Study 
The study may be prematurely terminated by the Investigator following consultation with the 
Sponsor, by the Sponsor or by the regulatory authorities. Following a decision to discontinue the 
trial, the Investigator will promptly inform the active study subjects and the HREC responsible for 
this trial, stating the reasons for discontinuation of the study and, furthermore, advise them in 
writing of any potential risks to the health of study subjects or other persons. It is the Sponsor’s 
responsibility to report the premature termination of the study to the regulatory authority(ies), 
when required by the applicable regulatory requirement(s).  
10. Analytical Methodology 
When applicable, samples will be transported to the bioanalytical facilities in at least two separate 
shipments, with each set of aliquots in separate shipments. Once the bioanalytical laboratory 
confirms receipt of the first shipment, the second set of aliquots may be sent. The samples should 
be packed on sufficient dry ice to keep them frozen for at least 72 hours. 
Tetra-Q will analyse SARS-CoV-2 specific antigen in serum samples using a validated method. 
The Peter Doherty Institute for Infection and Immunity will analyse live virus neutralisation in 
serum samples using a validated method. 
The University of Queensland will perform T-cell analysis via multi-colour cell cytometry which 
will include assessment of markers of a Th2 immune response (CD3, CD4, CD8, TFN-γ, TNF-α, 
IL-2, IL-4, IL-13, IL-17a, CD107a, and Granzyme B) in whole blood samples and cryopreserved 
peripheral blood mononuclear cells (PBMCs) using a validated method. 
The bioanalytical work in support of the study will be conducted in compliance with the GCP, 
using the SOPs in place each respective laboratory. These SOPs are in accordance with applicable 
regulations in the industry: Guidelines on Bioanalytical Method Validation, Good Laboratory 
Practice (GLP), and Guideline for GCP ICH E6 (R2). 

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Samples from subjects included in the Safety Population (see Section 11.4.3) and from subjects 
who were withdrawn from the study due to adverse events will be analysed. 
11.  Statistical Analyses 
A complete description of the statistical analyses and methods to be performed will be presented 
in a statistical analysis plan (SAP) to be finalised prior to database lock. This document will 
provide further details regarding the definition of analysis variables and analysis methodology to 
address all study objectives. The SAP will serve as a complement to the protocol and supersedes 
it in case of differences. 
An interim analysis will be performed once all Part 1 subjects (Cohorts 1,2 &3) have completed 
Day29, and immunology assays for all samples up to Day 29 are completed. A brief study status 
report will be prepared and will discuss the safety, tolerability and immunogenicity data following 
a single vaccination dose. A further interim analysis will be performed once all Part 1 subjects 
(Cohorts 1,2 &3) have completed Day 57, and immunology assays for all samples up to Day 57 
are completed. The Final CSR will be written following the completion of the Active Study Period 
Evaluation Visit (Day 57) and will discuss the safety/tolerability and immunogenicity data 
collected during the Active Study Period. 
The immunology assessments to be included for the Active Study Period in the CSR are the GMT 
of the serum antibody response (ELISA) to the Sclamp antigen and the serum NAb response by 
MN assay at Days 29 and 57 i.e. 28 days after the first and second dose respectively, the proportion 
of subjects with a ≥4 fold increase in titre above baseline by ELISA at Days 15, 29, 43 and 57 
compared to placebo, and the proportion of subjects with a ≥4 fold increase in titre above baseline 
by MN assay at Days 15, 29, 43 and 57 compared to placebo.  
Statistical assessments will include comparisons between the four treatment groups (A-D), as 
appropriate for each cohort and comparison of each treatment to the placebo group.  
An interim analysis will be performed once all Part 2 subjects (cohorts 4,5 and 6) have completed 
Day 57, and immunology assays for all samples up to Day 57 are completed. An addendum to the 
Final CSR will be written following the completion of the Active Study Period Evaluation Visit 
(Day 57) for Part 2 subjects and will discuss the safety, tolerability and immunogenicity data 
collected during the Active Study Period.  
Addenda to the final study report will be prepared following the 6 month follow-up visit (Day 209) 
and the 12 month follow-up visit (Day 394). These addenda will discuss the safety, tolerability, 
and immunogenicity data collected at the 6 month follow-up visit (the period between the Active 
Study Period and the 6 month follow-up visit) and the 12 month follow-up visit (the period 
between the 6 month follow-up visit and the 12 month follow-up visit). 
Demographic parameters will be summarized descriptively. TEAEs and injection site reaction data 
will be tabulated by study treatment for all subjects who were dosed (Safety Population). Safety 
and tolerability data will be reported using descriptive statistics. Changes from baseline values in 
vital signs and clinical laboratory parameters will be evaluated and tabulated by study treatment. 
No inferential statistical analysis of safety data is planned. 

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Descriptive statistics will be used to present all safety and immunogenicity results; number of 
observations (n), mean, standard deviation (SD), median, minimum (min), maximum (max), 
(including geometric mean, and CV% for immunogenicity data) for continuous data. For 
categorical variables, data will be tabulated with the number and proportion of subjects for each 
category by treatment group. 
Binary data i.e. percentages of subjects with seroconversion, will be tabulated for each group using 
unadjusted estimates and will be reported together with two-sided exact 95% confidence intervals 
(CIs), Clopper-Pearson. No multiplicity adjustment to the CI levels will be implemented. 
The difference between the proportions of treatment groups will be determined and the 
corresponding two-sided 95% CIs calculated using the exact uconditional CI based on the 
Farringont-Manning score statistic. Geometric means and 95% CIs will be calculated by taking 
the anti-logs of the means and the 95% CI of the log-transformed immunogenicity parameters. 
Exact CIs based upon the binomial distribution will be calculated for percentages. 
The analysis model for the Sclamp antibody, or the MN GMTs, will be performed using a general 
linear model on log-transformed (base 10) post-GMT titres as the outcome variable and as 
covariates such as treatment groups (dose) and log-transformed pre-vaccination titre. Model 
adjusted differences in means (on the log scale) will be produced with 95% confidence limits. The 
estimated difference between treatment groups and the confidence limits will be back-transformed 
to obtain an adjusted GMT ratio with 95% confidence limits. 
The measure of the unadjusted GMT ratio based on post-vaccination GMT only will also be 
presented. 
In addition, reverse cumulative distribution plots will be generated to display the distribution of 
the antibody response at Days 29 and 57 for the active study phase, and will be explored for Days 
209 and 396 (follow-up phase). Baseline titres for serum antibody to Sclamp, and MN titres to 
SARS-CoV-2 virus, will be less than or equal to the lower limit of quantitation (≤LLOQ) and will 
be imputed as ½ LLOQ. 
Bioanalysis of all samples up to, at least, Day 57 should be completed prior to the initiation of the 
immunogencity and statistical analyses. 
As the SARS-CoV-2 Sclamp study vaccine does not contain novel adjuvants nor excipients, and 
it is not administered via a novel delivery system nor route of administraition, no pharmacokinetic 
analyses will be conducted in agreement with the EMA Guideline on Clinical Evaluation of New 
Vaccines.5 
11.1 Safety Measurements 
Safety will be assessed by measuring the frequency and intensity of local and systemic solicited 
adverse events (AEs), unsolicited AEs, serious adverse events (SAEs), and safety laboratory data 
for all subjects. All solicited adverse events will be summarised according to the protocol defined 
severity grading scales. The proportion of subjects experiencing each adverse event will be 
presented for each symptom severity. Summary tables showing the occurrence of any local or 
systemic adverse event overall and at each time point will be presented. 

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Reactogenicity will be assessed by the proportion of subjects with solicited local and solicited 
systemic AEs up to 7 days after each vaccination and calculated for 3 time intervals after each 
vaccination: Days 1--3, Days 4--7, and Days 1--7. Post-administration solicited adverse events 
reported from Days 1-7 will be summarised by time interval, maximal severity and by vaccine 
group. The severity of solicited local adverse events, including injection site redness, swelling and 
induration will be summarised according to categories based on linear measurement: 2.5 to 5.0 
cm, 5.1 to 10.0 cm and >10 cm. 
Injection site pain and systemic reactions (except fever) occurring up to 7 days after each 
vaccination dose will be summarised according to “mild”, “moderate” or “severe”. Body 
temperature will be summarised by 0.5 °C increments from 36.0 °C up to ≥40 °C and will be 
reported by route of measurement. 
Unsolicited AEs will be assessed by the proportion of subjects with any unsolicited AEs for 28 
days after each vaccination. 
The proportion of subjects with SAEs, TEAS, non-scheduled GP visits, unsolicited medically 
attended AEs, unsolicited AEs leading to study withdrawal or decision by the PI to discontinue 
with the second dose, will be collected from study start until study completion.  
All spontaneously reported adverse events occurring during the study assessed by the Investigator 
as probably related, possibly related, or not related to vaccination will be recorded. 
The original terms used by the Investigator in the CRFs will be assigned to preferred terms using 
the MedDRA dictionary. The adverse events will then be grouped by MedDRA preferred terms 
into frequency tables according to system organ class and preferred terms within each system organ 
class then presented by vaccination group. Where an adverse event occurs more than once for a 
subject, the maximal severity and strongest relationship to the vaccine group will be counted. 
Separate summaries will be prepared as follows: 
• Serious adverse events 
• Adverse events that are probably or possibly related to the vaccine 
• Adverse events leading to a medically attended visit  
Safety parameters, ie.laboratory parameters, ECG and  vital signs, will be assessed by the PI or 
delegate, using the clinical site’s criteria for acceptance ranges as guidelines in making the medical 
assessment. Abnormal safety blood and urinalysis laboratory measurements will be assessed for 
severity in accordance with the scoring system described in the FDA Guidance for Industry –
Toxicity Grading Scale for Healthy Adults and Adolescent Volunteers Enrolled in Preventive 
Vaccine Clinical Trials(4) using the reference ranges specified by the testing laboratory, SydPath 
in accordance with the Laboratory Manual. 
Safety measurements which in the opinion of the investigator are deemed clinically significant will 
be recorded as adverse events 

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11.2 Immunogenicity 
Various approaches will be used in this study to assess the immunogenic response of the 
SARS--CoV--2 Sclamp vaccine in subjects: analysis of SARS-CoV-2 specific immune response 
via ELISA, analysis of domain specificity and immunoglobulin isotype induction via Luminex 
Assay, analysis of MN assessed via virus neutralisation, and ADCC via a bioluminescent reporter 
assay. Additionally, induction of poly-functional T-cells will be assessed via stimulation of 
PBMCs with vaccine specific antigen, and further analysed via various staining techniques coupled 
with multi-flow cytometry. While analysis of safety and tolerability is the primary outcome of this 
study, the combination of immunogenicity data collected will provide some indication of the 
potential efficacy of the vaccine for future studies to investigate further. 
Seroconversion rate is defined as a minimum 4-fold rise in post-vaccination titre at Days 29 and 
57 relative to Day 1. The baseline titres for serum antibody to Sclamp and MN titres to 
SARS-CoV-2 virus will be ≤ LLOQ and will be imputed as ½ LLOQ. 
Blood samples will be collected at specified visits according to the Schedule of Assessments 
included in Section 4, and blood volumes will be collected according to Section 9.9. 
The immunogenicity analyses will evaluate immunogenicity of SARS-CoV-2 Sclamp vaccine as 
measured by ELISA and MN assay.  
Additional immunologic assays, including ADCC reporter assay and Luminex assay will be used 
to conduct further exploratory analysis to determine antibody isotypes, domain specificities and 
functions that may be correlated with protection. 
Potential for seroconversion to trigger false positives on HIV testing will be assessed by assessing 
blood samples in a panel of point of care and investigative HIV detection diagnostics. 
Serum samples will be analysed by Sponsor designated qualified laboratory personnel blinded to 
the treatment assignment and the visit. Please see Laboratory Manual for complete details. 
11.3 Success Criteria 
In the absence of formal statistical hypotheses, the study will not be declared positive or negative 
according to pre-determined rules. The selection of an appropriate vaccine dosage and regimen for 
future studies will be determined by the joint evaluation of the safety and immunogenicity profiles 
of each dosage group and dosage regimen. 
11.4 Analysis Populations 
11.4.1  Intent-to-Treat (ITT) Population (Full Analysis Set, FAS) 
Includes all trial subjects that:  
- 
Provide consent; and 
- 
Are randomized. 

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The ITT Population will be used for all listings and demographic summaries, and will be listed 
according to the planned treatment. 
11.4.2 Safety Population 
Includes all trial subjects that:  
- 
Provide consent; and 
- 
Are randomized; and 
- 
Receive at least one dose of the study treatment, and 
- 
Provided any evaluable safety data.  
The Safety Population will be used for all safety analyses and will be analysed as actually treated. 
11.4.3  Immunogenicity Population up to Day 57 
Includes all subjects in the Safety Population that: 
- 
Have immunological results for Days 1, 15, 29, 36, 43, and 57 (subjects who withdraw 
early and do not complete all assessment days will still be included for analyses); and 
- 
Did not experience a laboratory confirmed COVID-19 illness between Day 1 and Day 57; 
and 
- 
Did not receive any prohibited medication during the study to Day 57 that is medically 
assessed to potentially impact the immune response (and immunogenicity results); and 
- 
Have no major protocol deviations affecting the primary immunogenicity outcomes as 
determined by the Sponsor prior to database lock and unblinding. 
The Immunogenicity Population will be the primary population used for immunogenicity analyses 
for the Day 57 analyses for each of Part 1 and Part 2.  
11.4.4 Full Immunogenicity Population 
Includes all subjects in the Immunogenicity Population that:  
- 
Have also completed follow-up examinations on Days 209 and 394; and 
- 
Did not experience a laboratory confirmed COVID-19 illness between Day 1 and Day 394. 
The Full Immunogenicity Population will be the primary population used for follow-up analyses. 
11.5 Immunogenicity Analysis 
For the evaluation of immunogenicity, vaccine antibody titres will be analysed using the 
Immunogenicity Population and the methodology described previously in Section 11: 

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• Geometric Mean Titres (GMT) on Days 1, 15, 29, 43 and 57, and 209 and 394 will be 
summarized using descriptive statistics by treatment group compared to placebo; 
• Seroconversion on Days 15, 29, 43, 57, 209 and 394, compared to placebo. Seroconversion 
is defined as the percentage of subjects with a ≥4 fold increase in post-vaccination titre 
compared to Day 1; 
• Geometric Mean Fold increases on Day 15 / Day 1, Day 29 / Day 1, Day 43 / Day 1, and 
Day 57 / Day 1, Day 209 / Day 1, and Day 394 / Day 1, compared to placebo; 
• Fold increase in antigen specific CD4+ T-cells at Days 8, 15, 29, 36, 43, and 57 compared 
to Day 1 for vaccine antigen dose versus placebo; 
• Fold increase in antigen specific CD8+ T-cells at Days 8, 15, 29, 36, 43, and 57 compared 
to Day 1 for vaccine antigen dose versus placebo; 
• Fold increase in antibody dependent cellular cytotoxicity (ADCC) at Days 15, 29, 43, 57, 
209, and 394 compared to Day 1 for vaccine antigen dose versus placebo; 
• Fold increase in antibodies elicited to the Receptor Binding Domain (RBD), N-Terminal 
Domain (NTD), and clamp trimerization domain on Days 15, 29, 43, 57, 209, and 394 
compared to Day 1 for vaccine antigen dose versus placebo; and 
• Fold increase in antigen specific humoral immune responses including isotypes IgM, IgA, 
IgE, and subtypes IgG1, IgG2, IgG3 and IgG4 at Days 15, 29, 43, 57, 209, and 394 
compared to Day 1 for vaccine antigen dose compared to placebo. 
Once all subjects have completed Day 57, an interim analysis will be performed. The 
immunogenicity analysis will be included as part of this interim analysis. 
12. Final Report 
A final report including clinical, bioanalytical, and statistical sections will be the responsibility of 
Delve Medical Writing and will be signed and approved by at least the Sponsor. 
An interim analysis will be performed once all Part 1 subjects (Cohorts 1,2 &3) have completed 
Day 29, and immunology assays for all samples up to Day 29 are completed. A brief study status 
report will be prepared and will discuss the safety, tolerability and immunogenicity data following 
a single vaccination dose. A further interim analysis will be performed once all Part 1 subjects 
(Cohorts 1,2 & 3) have completed Day 57, and immunology assays for all samples up to Day 57 
are completed. The Final CSR will be written in an unblinded manner following the completion of 
the Active Study Period Evaluation Visit (Day 57) and will discuss the safety, tolerability and 
immunogenicity data collected during the Active Study Period. (The period from first dose up until 
completion of the Day 57 assessments defines the Active Study Period). The immunology 
assessments to be included for the Active Study Period in the CSR are the GMT of the serum 
antibody response (ELISA) to the Sclamp antigen and the serum NAb response by MN assay at 
Days 29 and 57 i.e. 28 days after the first and second dose respectively, the proportion of subjects 
with a ≥4 fold increase in titre above baseline by ELISA at Days 15, 29, 43 and 57 compared to 

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placebo, and the proportion of subjects with a ≥4 fold increase in titre above baseline by MN assay 
at Days 15, 29, 43 and 57 compared to placebo. 
An interim analysis will be performed once all Part 2 subjects (cohorts 4,5 and 6) have completed 
Day 57, and immunology assays for all samples up to Day 57 are completed. An addendum to the 
Final CSR will be written following the completion of the Active Study Period Evaluation Visit 
(Day 57) for Part 2 subjects and will discuss the safety, tolerability and immunogenicity data 
collected during the Active Study Period.  
Addenda to the final study report will be written following the 6 month follow-up visit (Day 209) 
and the 12 month follow-up visit (Day 394). These addenda will discuss the safety and 
immunogenicity data collected at the 6 month follow-up visit (the period between the Active Study 
Period and the 6 month follow-up visit) and the 12 month follow-up visit (the period between the 
6 month follow-up visit and the 12 month follow-up visit). 
In the event that the study is prematurely terminated, Delve Medical Writing will produce an 
abbreviated safety report. In such an event, raw data will not be submitted with the abbreviated 
report but will be archived at the clinical site, unless requested by the Sponsor. 
13. Regulatory Considerations and Quality Assurance 
13.1 Independent Ethics Committee Approval of Protocol and Other Study Documents 
The Investigator(s) agree to provide the HREC with all appropriate documents, including a copy 
of the protocol/amendments, ICFs, advertising text (if any), Investigator’s Brochure and any other 
written information provided to study subjects. The trial will not begin until the Investigators have 
obtained the HREC favourable written approvals for the above-mentioned study documents. A 
properly executed written ICF shall be read, signed, and dated by each subject prior to entering the 
trial or prior to performing any study procedure. The original signed and dated ICF will be kept at 
the clinical site, and a copy will be given to the subject.  
In the event that the protocol is amended, the revised protocol must be approved by the HREC 
prior to its implementation, unless the changes involve only logistical or administrative aspects of 
the trial. If a revised ICF is introduced during the study, each subject’s further consent must be 
obtained. The new version of the ICF must be approved by the HREC, prior to subsequently 
obtaining each subject’s consent. 
The Investigator and the Sponsor’s representative must sign the protocol and its amendments (if 
any) before initiating the study. 
It is the Sponsor’s responsibility to submit the protocol and its amendments (if any), and the ICFs 
to regulatory authorities when necessary. 
13.2 Compliance 
This study will be conducted in compliance with the protocol, GCP, the requirements of Directive 
2001/83/EC Annex I, as amended by Directive 2003/63/EC and Directive 2001/20/EC, and all 
applicable regulations. The study will also be conducted in compliance with the recommendations 

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laid down in the most recent version of the Declaration of Helsinki, with the exception that 
registration of such Phase 1 trials in a publicly accessible database is not mandatory.  
13.3 Quality Assurance Program 
Syneos Health has established Quality Control (QC) and Quality Assurance (QA) systems with 
written SOPs to ensure that the study will be conducted and data will be generated, recorded, and 
reported in compliance with the protocol, GCP, and applicable regulatory requirements. A rigorous 
QC program is applied to ensure accuracy of all data and reports. QA oversees a complementary 
risk-based program of audits to assure compliance with applicable regulations and Syneos Health's 
prescriptive documentation. 
13.4 Audits, Inspections and Monitoring 
In accordance with the principles of GCP and GLP, the study may be inspected by regulatory 
authorities, the Sponsor and Syneos Health. The Sponsor is entitled to access information about 
the status of the study and to review the original documents of the study. 
14. Confidentiality and Retention of Study Records 
This document contains trade secrets and commercial information that is confidential and may not 
be disclosed to third parties. Persons to whom this study protocol is disclosed must be informed 
that all the information herein is confidential and may not be further divulged. These restrictions 
will apply as well to all future communications if deemed privileged or confidential. Publication 
of the study results may only be allowed with written permission from the Sponsor. 
All information on a subject obtained during the conduct of the study will be kept confidential. 
Subjects will be identified by an anonymized identifier on all samples and study records provided 
to the Sponsor or designee. In compliance with ICH GCP, the Sponsor’s authorized 
representatives, monitor(s), auditor(s), HREC, and regulatory authority(ies) will be granted direct 
access to the subject’s original trial-related records for verification of clinical trial procedures 
and/or data, without violating the confidentiality of the subject, to the extent permitted by the 
applicable laws and regulations. Consent from the subject for disclosure of such information will 
be obtained in writing in the ICF. In addition, should a subject require medical care or 
hospitalization during the course of the study, the clinical site may contact the treating physician 
with the subject’s consent, except that consent may not be requested if there is an emergency 
situation. If the results of the study are published, the subject’s identity will remain confidential. 

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15. References 
1 World Health Organisation: Coronavirus Disease 2019 (SARS-CoV-2): Situation Report-
-51. WHO website. Published March 11, 2020. Accessed March 27, 2020. 
https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-
51-covid-19.pdf 
2 Guan, WJ. et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J 
Med. 2020. 382; 1708-1720. 
3 Huang, C. et al. Clinical features of patients infected with 2019 novel coronavirus in 
Wuhan, China. Lancet. 2020. 395(10223); 497–506. 
4 FDA Guidance for Industry – Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventative Vaccine Clinical Trials. Revised date 17 May 2019. 
Accessible online: https://www.fda.gov/media/73679/download 
5 Committee for Medicinal Products for Human Use (CHMP), EMA. Guideline on 
strategies to identify and mitigate risks for first-in-human and early clinical trials with 
investigational medicinal products. EMEA/CHMP/SWP/28367/07 Rev. 1. 20 July 2017. 
Accessible online: https://www.ema.europa.eu/en/documents/scientific-
guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-
investigational_en.pdf 
 
 

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Appendix I Checklist for Medical History Follow-Up for Persons Who Meet the Protocol 
Defined COVID-19 Case Definition. 
Clinical Diagnostic 
Category 
Sign/symptom 
Outcome (please check box) 
A.  
At least one sign or 
symptom of lower 
respiratory tract disease: 
New onset persistent dry 
(non-productive) cough 
 
New onset tachypnoea or 
dyspnoea or low oxygen 
saturation 
 
At least one 
sign/symptom for 
Category A 
 
B.  
Fever or history of fever 
(defined as body 
temperature of >38.0 °C 
irrespective of method) 
Fever as per definition 
 
Fever as defined in 
Category B 
 
C.  
At least one sign or 
symptom of viral illness: 
New onset myalgia 
 
New onset chills 
Sore throat 
New onset loss of smell or 
taste 
Diarrhoea 
 
 
At least one 
sign/symptom for 
Category C 
 
Meets Criteria for 
COVID-19 Clinical 
Disease 
 
At least 2 of 3 
clinical diagnostic 
categories checked