A Double Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate Safety, Tolerability and Immunogenicity of a Mycobacterium Bovis BCG (Bacillus Calmette-Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 Years of Age
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Pontificia Universidad Catolica de Chile

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1. 
TITLE PAGE 
 
A Double-Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate 
Safety, Tolerability and Immunogenicity of a Mycobacterium bovis BCG (Bacillus Calmette-
Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of 
Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 
Years of Age 
Final Integrated Clinical/Statistical Report 
 
Trial Number code:  
1) Public Health Institute of Chile Registry (Nº 4060). 
2) Clinicaltrials.gov identifier: NCT03213405.  
Development Phase: 
Phase I 
Indication Studied: 
Respiratory Syncytial Virus Infections 
Product: 
rBCG-N-hRSV 001 
Form/Route: 
Intradermal 
Sponsor: 
Pontificia Universidad Católica de Chile 
Principal Investigator: 
Alexis M. Kalergis, PhD 
Clinical/Medical Monitor: 
Katia Abarca, MD 
Laboratory Monitor: 
Susan Bueno, PhD 
Biostatistician: 
Jaime Cerda, MD 
Pharmacovigilance (Safety 
Narratives): 
Jose Vicente Gonzalez, PhD  
Clinical Trial Initiation 
Date: 
June 27 2017 
Clinical Trial Completion 
Date: 
January 8 2018 
Date of the report: 
January 8 2018 
Version Number: 
0.2  
This study was performed in compliance with Good Clinical Practice 

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2. 
TABLE OF CONTENTS 
Page 
1. 
TITLE PAGE  
 
 
 
 
 
 
 
 
I 
2. 
TABLE OF CONTENTS 
 
 
 
 
 
 
 
II 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
VI 
4. 
LIST OF TABLES  
 
 
 
 
 
 
 
          VII 
5. 
LIST OF FIGURES  
 
 
 
 
 
 
 
IX 
6. 
ETHICS 
 
 
 
 
 
 
 
 
 
1 
6.1. 
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) 1 
6.2. 
Ethical Conduct of the Study  
 
 
 
 
 
 
1 
6.3. 
Subject Information and Consent 
 
 
 
 
 
 
1 
7. 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
 
2 
7.1. 
Administrative Structure at the Clinical Sites 
 
 
 
 
2 
7.2 
Administrative Structure for the Trial 
 
 
 
 
 
2 
8. 
INTRODUCTION 
 
 
 
 
 
 
 
 
3 
9. 
STUDY OBJECTIVES 
 
 
 
 
 
 
 
5 
10. 
INVESTIGATIONAL PLAN 
 
 
 
 
 
 
6 
10.1. Overall Study Design and Plan Description  
 
 
 
 
6 
10.2. Rationale for Study Design 
 
 
 
 
 
 
 
7 
10.3. Selection of Study Population 
 
 
 
 
 
 
8 
10.3.1. Inclusion Criteria 
 
 
 
 
 
 
 
 
8 
10.3.2. Exclusion Criteria 
 
 
 
 
 
 
 
 
8 
10.3.3. Removal of Subjects from Therapy or Assessment  
 
 
 
10 
10.4. Vaccinations/Treatments 
 
 
 
 
 
 
 
11 
10.4.1. Vaccinations/Treatments Administered 
 
 
 
 
 
11 
10.4.2. Identity of Investigational Product(s)  
 
 
 
 
 
11 
10.4.3. Method of Assigning Subjects to Study Groups 
 
 
 
 
11 
10.4.4. Selection of Doses in the Study 
 
 
 
 
 
 
11 
10.4.5. Selection and Timing of Dose for Each Subject 
 
 
 
 
12 
10.4.6. Blinding 
12 
10.4.7. Prior and Concomitant Therapy 
12 

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10.4.8. Treatment Compliance 
 
 
 
 
 
 
 
12 
10.5. Efficacy/Immunogenicity and Safety Variables 
 
 
 
 
12 
10.5.1. Efficacy/Immunogenicity and Safety Measurements Assessed and Flow Chart 
12 
10.5.2. Appropriateness of Measurements 
 
 
 
 
 
 
13 
10.5.3. Primary Efficacy/Immunogenicity Endpoints 
 
 
 
 
13 
10.5.4. Primary Safety Endpoints 
 
 
 
 
 
 
 
13 
10.5.5. Secondary Efficacy/Immunogenicity and Safety Endpoints  
 
 
14 
9.5.6. Drug Concentration Measurements  
 
 
 
 
 
14 
10.6. Data Quality Assurance 
 
 
 
 
 
 
 
14 
10.6.1. Data Collection and Management 
 
 
 
 
 
 
14 
10.6.1.1. 
Data Recording Methods 
 
 
 
 
 
 
15 
10.6.1.2. 
Subject Identifiers 
 
 
 
 
 
 
 
15 
10.6.2. Monitoring, Auditing, and Archiving  
 
 
 
 
 
15 
10.6.3. Database Lock 
 
 
 
 
 
 
 
 
16 
10.7. Statistical Methods Planned in the Protocol and Determination of Sample Size 
16 
10.7.1. Sample Size  
 
 
 
 
 
 
 
 
16 
10.7.2. Statistical Analysis Plan 
 
 
 
 
 
 
 
17 
11. 
STUDY SUBJECTS  
 
 
 
 
 
 
 
18 
11.1. Disposition of Subjects 
 
 
 
 
 
 
 
18 
11.1.1 Demographic Data by Study Group  
 
 
 
 
 
18 
11.1.2. Summary of Prior and Concurrent Medical Conditions 
 
 
 
18 
11.1.3. Visit Schedule  
 
 
 
 
 
 
 
 
18 
11.1.4. Vital Signs Grading 19 
11.2. Protocol Deviations 20 
12. 
EFFICACY/IMMUNOGENICITY EVALUATION 21 
12.1. Analysis Populations 21 
12.2. Demographics and Other Baseline Characteristics 
21 
12.2.1. Prior and Concurrent Medical Conditions 
22 
12.2.2. Prior and Concomitant Medications 22 
12.3. Measurements of Treatment Compliance 
22 
12.4. Efficacy/Immunogenicity Results and Tabulations of Individual Subject Data 
22 
12.4.1. Methodology and Primary Statistical Analysis of Efficacy/ Immunogenicity Data 22 

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12.4.1. 1 Handling of Dropouts or Missing Data 23 
12.4.2. Tabulation of Individual Response Data 
23 
12.4.3. Efficacy/Immunogenicity Conclusions 
24 
13. 
SAFETY EVALUATION 
25 
13.1. Extent of Exposure 
25 
13.2. Adverse Events (AEs) 25 
13.2.1. Brief Summary of Adverse Events 
25 
13.2.2. Display of Adverse Events 
26 
13.2.2.1. 
Solicited AEs 28 
12.2.2.2. 
Unsolicited AEs 
28 
13.2.3. Analysis of Adverse Events 30 
13.3. Deaths, Other Serious Adverse Events, and Other Significant Adverse Events 30 
13.3.1. Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events 
 
 
30 
13.3.1.1. Deaths 
31 
13.3.1.2. Serious Adverse Events 
31 
13.3.1.3. 
Other Significant Adverse Events 
 
31 
13.3.2. Narratives of Deaths, Other Serious Adverse Events, and Other Significant Adverse 
Events  
 
 
 
 
 
31 
13.3.3. Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events 
32 
13.4. Clinical Laboratory Evaluation 
32 
13.4.1. Individual Laboratory Measurements and Abnormal Laboratory Values 
32 
133.4.2. 
Evaluation of Each Laboratory Parameter 
34 
12.4.2.1. 
Laboratory Values over Time 34 
13.4.2.2. 
Individual Subject Changes 34 
13.4.2.3. 
Display of Laboratory Results 
36 
13.4.2.4. 
Chemistry Results 
 
 
36 
13.4.2.5. 
Hematology Results  
 
36 
13.4.2.6. 
Urinalysis Results 
 
38 
13.5. Vital Signs, Physical Exam Findings, and Other Observations Related to Safety 
38 
13.5.1. Vital Signs Grading 39 
13.5.2. Abnormal Vital Signs  
39 

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13.6. Concomitant Medications 
40 
12.7. Pregnancies (if applicable) 
40 
12.8. Safety Conclusions 
40 
14. 
DISCUSSIONS AND OVERALL CONCLUSION 41 
15. 
TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE 
TEXT 44 
16. 
REFERENCE LIST 70 
 
 
 

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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
AE: Adverse Events 
ARTIs: Acute Respiratory Tract Infections 
BCG: Bacillus Calmette-Guérin 
BCG-WT: Nonrecombinant, wild type Bacillus Calmette-Guérin 
CFU: Colony Forming Units 
IC: Informed Consent DSMB: Data and Safety Monitoring Board 
FI-rRSV: Formalin-inactivated vaccine 
ID: Identification Number 
HRP: Horseradish Peroxidase 
hRSV: Human Respiratory Syncytial Virus 
IFN-γ: Interferon Gamma 
IL-2: Interleukin 2 
NA: Not Applicable 
N-RSV: Respiratory Syncytial Virus Nucleoprotein 
PPD: purified protein derivative of Mycobacterium tuberculosis 
rBCG-N-hRSV: recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein 
of hRSV 
Th: T helper cells 
TNF-α: Tumor necrosis factor alpha 
 
 

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4. 
LIST OF TABLES  
Page 
1.- Table I: Study design …………………………………………………………………………7 
2.- Table II: Safety and Efficacy/Immunogenicity evaluation…………………………………...13 
3.- Table III: Subjects receiving investigational product………………………………………...17 
4.- Table IV: Protocol deviation by each subject………………………………………………...19 
5.- Table V: Immunogenicity individual response………………………………………………..22 
6.- Table VI: SAE from the three cohorts, to date January 3, 2018………………………………25 
7.- Table VII: Cohorts A, B and C, at day 30……………………………………………………25 
8.- Table VIII: Cohorts A, B and C, to date January 8th, 2018……………………………………26 
9.- Table IX: Listing of local adverse events by subjects…………………………………………27 
10.- Table X: Listing of general adverse events by subjects……………………………………...32 
11.- Table XI: Serious adverse events……………………………………………………….……48 
12.- Table XII: Laboratory adverse events from cohort A, B and C at day 30…………………...50 
13.- Table XIII: Vital signs grading………………………………………………………………52 
14.- Table XIV: Abnormal vital signs……………………………………………………………53 
15.- Table XV: Cohort by subject’s number……………………………………………………...58 
16.- Table XVI: Demographic data by study group………………………………………………59 
17.-Table XVII. Study Visit Schedule……………………………………………………………59 
18.- Table XVIII: Immunogenicity individual response………………………………………….61 
19.- Table XIX: Solicited general adverse events grade 3………………………………………64 
20.- Table XX: Number of Non-Solicited clinical adverse events………………………………64 

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21.- Table XXI: Grade 3 laboratory adverse events and follow-up (to date)……………………..66 
22.- Table XXII: Biochemistry results from the 3 laboratory cohorts…………………………….68 
23.- Table XXIII: Haematology results from all laboratory cohorts……………………………..69 
24.- Table XXIV: Haematology results from all 3 clinical cohorts…………………………...…70 
25.- Table XXV: Urinalysis results from all laboratory cohorts……………………………..….70 
26.- Table XXVI: Urinalysis results from all clinical cohorts…………………………………....71 
27.- Table XXVI: Vital signs from all clinical cohorts…………………………………………...71 
 
 

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5. 
LIST OF FIGURES  
Page 
1.- Figure 1: Clinical study flow diagram…………………........................................................17 
The phase 1 study was a double blind, dose escalation trial performed in healthy male 
adults. Each cohort included 6 volunteers vaccinated with escalating doses of rBCG-N-hRSV 
(5x103 CFU; 5x104 CFU; 1x105 CFU) and 2 volunteers vaccinated with the standard BCG 
(BCG-WT) (2x105 CFU). Furthermore, the safety data for each cohort were evaluated after all 
subjects in each group had reached 30 days post-vaccination to determine whether the dose 
escalation could continue. 
2.- Figure 2: Measurement of specific cellular immune responses by flow cytometry against PPD 
antigens (in black) and hRSV-N protein (in white)…..57 
The results are expressed as fold changes (log2)  compared with visit 1 (day 0) for CD4+ 
and CD8+ T cells that secreted IL-2 and TNF-a at 14 and 30 days post-vaccination for the three 
dose groups receiving rBCG-N-hRSV (5x103 CFU, 5x104 CFU, 1x105 CFU) and for BCG-WT 
(2x105 CFU). 
3.- Figure 3: Measurement of specific cellular immune responses by ELISPOT against PPD 
antigens (in black) and hRSV-N protein (in white)............................59 
The results are expressed as fold changes (log2)  compared with visit 1 (day 0) for CD4+ 
and CD8+ T cells that secreted IFN-g and IL-2 at times 14, 30 and 180 days post-vaccination 
for the three dose groups receiving rBCG-N-hRSV (5x103 CFU, 5x104 CFU, 1x105 CFU) and 
for BCG-WT (2x105 CFU). 
4.- Figure 4: Measurement of PPD- and hRSV-N-specific humoral immune responses (in black or 
white 
bars, 
respectively) 
by 
indirect 
ELISA 
assay.............................................................................................................................................60 
The results are expressed as fold changes (log10) compared with visit 1 (day 0) at 60, 120 
and 180 days post-vaccination for the three dose groups of rBCG-N-hRSV (5x103 CFU, 5x104 
CFU, 1x105 CFU) and for BCG-WT (2x105 CFU).

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6. 
ETHICS 
6.1. 
Independent Ethics Committee (IEC) or Institutional Review Board 
(IRB) 
The first signed informed consent was provided to the Institutional Ethics Committee on 
June 19th, 2017. The trial was approved by both, the Institutional Ethical Committee of the 
Pontificia Universidad Católica de Chile (document number 15-216) and the Chilean Public Health 
Institute (Instituto de Salud Pública de Chile, document number EC819077/16). 
6.2. 
Ethical Conduct of the Study 
The trial (clinicaltrials.gov NCT03213405) was conducted in Santiago of Chile, in a single 
center (Clinical Research Center of Pontificia Universidad Católica de Chile (CICUC)). The 
protocol was conducted according to the current Tripartite Guidelines of Good Clinical Practice, 
Declaration of Helsinki (17) and local regulations (Instituto de Salud Pública). Written informed 
consent was obtained from each participant prior to study entry. A Data Safety Monitoring Board 
(DSMB) evaluated safety data for each dose cohort after all subjects of the group reached day 30 
of follow up to determine whether the dose escalation could continue. 
6.3. 
Subject Information and Consent 
The Informed Consent (IC) document version 3.0 dated March 10th of 2017 was used.  
During the screening visit, the study was explained to each individual and each subject signed the 
consent form in duplicate. One copy was provided to the subject and the other copy was archived 
in the subject file for this study. The identity of each participant was confirmed and documented 
using a unique, study-specific identification number (ID) which was archived in the study file. 
All the volunteers signed the IC approved by the Institutional Ethic Committee of the 
Facultad de Medicina of the Pontificia Universidad Católica de Chile, before starting the first 
screening visit. 
 
 
 

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7. 
INVESTIGATORS AND STUDY ADMINISTRATIVE 
STRUCTURE 
7.1. 
Administrative Structure at the Clinical Sites 
Lead Site 
Principal Investigator: 
Alexis M. Kalergis, PhD 
Clinic Manager: 
 
Katia Abarca, MD 
Laboratory Manager:  
Susan Bueno, PhD 
Study Coordinator: 
 
Carolina Iturriaga, RN 
Laboratory Supervisor: 
Susan Bueno, PhD and Alexis M. Kalergis, PhD 
 
7.2. 
Administrative Structure for the Trial 
Principal Investigator:  
Alexis M. Kalergis, PhD 
Scientific Lead:  
Alexis M. Kalergis, PhD 
Medical Monitor: 
Katia Abarca, MD 
Laboratory Supervisor 
Susan Bueno, PhD 
Clinical Project Manager: 
Carolina Iturriaga, RN 
Biostatistician: 
Jaime Cerda, MD, Pontificia Universidad 
Católica de Chile. 
Pharmacovigilance (Safety Narratives): 
 Jose Vicente Gonzalez, PhD 
Report Author: 
Alexis M. Kalergis, PhD 
Statistical and Data Coordinating Center:  
Pontificia Universidad Católica de Chile  
Clinical Monitoring: 
SMOLAM LTDA 
 
 
 

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8. 
INTRODUCTION 
The human respiratory syncytial virus (hRSV) is of great public health significance causing 
acute respiratory tract infections (ARTIs) in children worldwide (1). hRSV can cause mild 
manifestations such as rhinorrhea, cough and congestion, to severe manifestations such as 
alveolitis, bronchiolitis and pneumonia (2). Importantly, worldwide hRSV infections are 
responsible for more than 3 million hospitalizations and more than 33 million ARTI episodes each 
year among children up to five years (1).  
 
No licensed vaccine is currently available to prevent hRSV infection. The only current 
hRSV treatment is a humanized monoclonal antibody that targets the F protein of the virus. This 
approach is only used as a prophylactic treatment, mainly for high-risk infants to prevent the most 
severe symptoms of hRSV infection (4). An early hRSV vaccine attempt utilized a formalin-
inactivated vaccine (FI-hRSV) in the 1960s (5). Unfortunately, the administration of this vaccine 
caused hospitalization in up to 80% of vaccinated children, triggering an exacerbation of the 
disease upon exposure to natural infection (6, 7). Therefore, there is a need to develop a safe and 
effective hRSV vaccine that induces a protective immunological response, but without enhancing 
pulmonary disease after hRSV infection. It has been shown that in children with acute hRSV 
bronchiolitis a predominantly T helper (Th)-2 cell biased response occurs and may be responsible 
for the pathologic outcomes (8). Further, a reduction in the frequency of γδ T cells producing IFN-
γ has also been observed in samples from children presenting hRSV disease (9). These previous 
studies suggest that immunologic protection against hRSV involves a type 1-biased immune 
response (including CD4+ Th1 cells producing IFN-γ, TNF-α and IL-2), whereas enhanced hRSV 
disease is associated with a type 2-biased immune response (including CD4+ Th2 cells producing 
IL-4, IL-5 and IL-13). Therefore, a current view is that optimal hRSV vaccines should induce 
potent CD4+ Th1 cell responses, and not CD4+ Th2 cell responses. According to the 2017 report 
from Program for Appropriate Technology in Health (PATH, www.path.org), multiple hRSV 
vaccine candidates are in clinical evaluation including live-attenuated, particle-based and 
adenovirus-vectored approaches (10). 
A vaccine candidate consisting on a recombinant Mycobacterium bovis (BCG) that 
expresses the nucleoprotein (N) of hRSV (rBCG-N-hRSV) has been developed by the team of Dr. 
Alexis Kalergis at the Pontificia Universidad Católica de Chile (11). BCG has been historically 

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used to prevent tuberculous meningitis and miliary TB disease and has been applied more than 4 
billon times since its introduction in most countries around the world (12). In addition, BCG 
induces strong Th1, and not Th2 immune responses in both, animal models and in humans, and 
therefore is hypothesized to be an ideal vector for a vaccine directed against hRSV infection (13). 
Importantly, immunization with rBCG-N-hRSV in mice prevented lung associated damage from 
hRSV infection, decreased inflammatory cell infiltrations and induced an early recruitment of 
CD4+ and CD8+ T cells to the lungs (11, 14, 15). In addition, rBCG-N-hRSV generated an effective 
neutralizing antibody response in RSV-infected mice (16).  
 
 

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9. 
STUDY OBJECTIVES 
The primary objective of this study was to characterize the safety and tolerability of 
escalating doses of the rBCG-N-hRSV vaccine, including doses of 5x103, 5x104 and 1x105 CFU 
in healthy adult males 18 to 50 years of age. 
The secondary objectives included characterization of the immune responses induced 
against the hRSV-N and against mycobacterial antigens with escalating doses of the rBCG-N-
hRSV vaccine. 
 

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10. 
INVESTIGATIONAL PLAN 
10.1. 
Overall Study Design and Plan Description 
This was a phase I, double blind trial to evaluate the safety, tolerability and 
immunogenicity of an investigational recombinant BCG vaccine expressing hRSV-N compared 
to a control, nonrecombinant wild type BCG vaccine (conventional BCG) within each cohort, 
performed in healthy adult males 18 to 50 years of age. 
After a full clinical and laboratory evaluation to exclude those with underlying diseases, 
immunodeficiency and latent tuberculosis infection per inclusion and exclusion criteria, the 
participants were enrolled into three cohorts. Within each cohort, the participants were randomly 
and in a blinded-manner assigned to receive the tested vaccine (rBCG-N-hRSV) or the control 
vaccine (conventional BCG). 
Each cohort was vaccinated according to their assigned groups followed by a period of 6 
months of follow-up.  Safety data was evaluated by a Data and Safety Monitoring Board (DSMB), 
that determined whether, according to previously defined parameters, the escalation to the next 
cohort was possible, or whether the study needed to be halted due to safety concerns. Blood, saliva 
and urine samples were obtained pre-vaccination and on days 14, 30 and 180 post-vaccination, 
and (peripheral blood mononuclear cells) PBMCs were purified from the blood for cellular 
immune assays and serum isolated for humoral immune assays.  The study design can be seen in 
Table I. 
 
Table I: Study design 
Cohort 
Number of 
vaccinated 
Safety analysis by 
CIMD 
Follow up 
Study completion 
A 
n=8 
6 rBCG-N-hRSV 
5x10^3 
2 BCG 2x10^5 
Day 30 
Until day 180 
n=8 per group 
TOTAL 
VACCINATED THAT 
COMPLETED THE 
STUDY=24 
B 
n=8 
6 rBCG-N-hRSV 
5x10^4 
2 BCG 2x10^5 

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C 
n=8 
6 rBCG-N-hRSV 
1x10^5 
2 BCG 2x10^5 
Samples were taken from all enrolled subjects at different time-points for the following purposes: 
Day 0:  
Venous blood for basal immunogenicity assays (cellular and humoral, 26 ml total). 
Day 7:  
Venous blood (16 ml) for laboratory adverse events study. Venous blood (4 ml), urine (10 ml) 
and saliva (>1 ml) for BCG excretion studies.  
Day 14:  
Venous blood (16 ml) for laboratory adverse events study. Venous blood immunogenicity 
assays (cellular and humoral, 26 ml total). Venous blood (4 ml), urine (10 ml) and saliva (>1ml) 
for BCG excretion studies. 
Day 30:  
Venous blood (16 ml) for laboratory adverse events study. Venous blood immunogenicity 
assays (cellular and humoral, 26 ml total). Venous blood (4 ml), urine (10 ml) and saliva (>1ml) 
for BCG excretion studies. 
Day 60:  
Venous blood (16 ml) for laboratory adverse events study. Venous blood immunogenicity 
assays (cellular and humoral, 26 ml total). Venous blood (4 ml), urine (10 ml) and saliva (>1ml) 
for BCG excretion studies. 
Day 120:  Venous blood (16 ml) for laboratory adverse events study. Venous blood immunogenicity 
assays (cellular and humoral, 26 ml total). Venous blood (4 ml), urine (10 ml) and saliva (>1ml) 
for BCG excretion studies. 
Day 180:  Venous blood (16 ml) for laboratory adverse events study.  Venous blood immunogenicity 
assays (cellular and humoral, 26 ml total). Venous blood (4 ml), urine (10 ml) and saliva (>1ml) 
for BCG excretion studies. 
10.2. 
Rationale for Study Design 
Because this was a first-in-human phase I trial to study a novel recombinant BCG vaccine 
designed to protect against both, hRSV and Mycobacterium tuberculosis infections, a careful dose 
escalation trial was designed with safety monitoring between escalation groups.  The specific doses 
were selected based on the standard dose of BCG utilized in Chile for infant vaccination to protect 
against TB. The first group received a recombinant RSV-BCG vaccine dose that was equivalent 
to 1/100th of the standard dose of non-recombinant BCG licensed for use in infants in Chile.  The 
second group received a recombinant RSV-BCG vaccine dose that was equivalent to 1/10th of the 
standard dose of non-recombinant BCG licensed for use in infants in Chile. The third group 
received a recombinant RSV-BCG vaccine dose that was equivalent to a full dose of non-
recombinant BCG licensed for use in infants in Chile.  The novel recombinant hRSV-BCG vaccine 

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could provide the advantage of inducing protective immunity against both, hRSV and TB infection 
and disease. If shown to be safe and effective, this one recombinant vaccine could replace standard 
BCG vaccination currently given to protect against TB. The reason to perform a double blind study 
was to assure that the study would not be biased. It is worth mentioning that, due that BCG 
vaccination is mandatory in Chile, all enrolled subjects were BCG-positive. 
 
10.3. 
Selection of Study Population 
10.3.1. 
Inclusion Criteria 
The inclusion criteria were as follows: 
- 
Chilean male between 18 and 50 years old. 
- 
Evidence of voluntary participation through documentation of informed 
consent. 
- 
Good health, according to the medical history, physical examination and normal 
laboratory test. 
- 
A history of vaccination with BCG once or twice during the participant’s life. 
In this population, the vaccine will work as a boost for BCG. 
10.3.2. 
Exclusion Criteria 
The exclusion criteria were as follows: 
- 
Symptoms or diagnosis suggesting any type of systemic disease including renal, 
liver, 
cardiovascular 
or 
pulmonary 
impairment, 
immunodeficiency, 
autoimmune diseases, malignancies, psychiatric or other conditions that could 
interfere with the interpretation of the results or compromise the health of the 
participants. 
- 
Body mass index lower than 19 and higher than 30 kg/m2 and/or weight under 
50 kg. 

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Not being able to attend all the study visits (face-to-face and telephone contacts) 
or follow the specified instructions (fasting, avoidance of intense physical 
exercise during the 24 hours preceding the study visits and 72 hours post-
vaccination). 
- 
Signs of latent or active infection with Mycobacterium tuberculosis: 
QuantiFERON-TB positive test or Chest X-ray suggesting Tuberculosis (TB). 
- 
Positive screening for the human immunodeficiency virus (HIV), hepatitis B 
surface antigen (HBsAG) and hepatitis C virus (HCV). 
- 
Evidence of primary or secondary immunodeficiency, determined by history, 
physical test and levels of serum immunoglobulins and lymphocytes sub-
populations at the screening. 
- 
Use of immunosuppressing drugs during the last 6 months prior to, or during 
the study. 
- 
Use of inhaled corticosteroids for bronchial hyper-reactivity during the last 
year. 
- 
History of close contact exposure to patients with Tuberculosis or other 
mycobacterial infections, even if under treatment. 
- 
History of substance abuse (drugs or alcohol), according to DMS IV (See 
footnote*). 
- 
Occurrence of any serious adverse events associated with previous BCG 
vaccination. 
- 
History of severe allergic reactions or anaphylaxis to vaccines. 
- 
History of severe infections (use of IV antibiotics, latent TB, herpes zoster) six 
months previous to screening. 
- 
Refusal of condom use during sexual contact or abstinence from sexual activity 
during the study (See footnote**). 
- 
Administration of immunoglobulins or blood-derived products six months 
previous to participation in the study or planned use of these products during 
the study. 
- 
Eczema at the vaccination site (deltoid zone). 
- 
Antecedents of keloid scar. 

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Being vaccinated with BCG during the last 10 years. 
- 
History of being vaccinated with BCG three or more times or the presence of 
three BCG scars. 
- 
Receipt of other investigational products 30 days previous to the study. 
- 
Administration of any vaccine 8 weeks prior to recruitment. 
- 
Administration of any other vaccine during the first 30 days after vaccination 
with the rBCG-hRSV. 
- 
Acute illness symptoms and/or feverish symptoms at the time, or during the last 
seven days prior to enrollment (fever defined as an oral or axillary temperature 
of >38°C). 
(*) Substance abuse (drugs or alcohol): Maladaptive pattern of substance abuse that leads to a 
clinically significant mental or physical deterioration during the previous twelve months.  
Clinically significant deterioration would include evidence of any of the following: inability to 
complete  personal and/or professional obligations; use of drugs or alcohol in dangerous situations, 
such as driving a vehicle; and legal problems related to drug or alcohol use. 
(**) Given the remote possibility of negative effects produced by the vaccination on sperm, only 
volunteers that are not planning on conceiving a child during the study duration were enrolled. 
During each visit, abstinence or the use of effective contraceptive device will be confirmed. 
10.3.3. 
Removal of Subjects from Therapy or Assessment 
18 subjects were not enrolled in the study because they presented one or more exclusion 
parameters, including: Gilbert Syndrome, hepatitis B and latent Mycobacterium tuberculosis 
infection, HIV infection, three (3) BCG scars and screening tests out of the normal range. All 
enrolled subjects completed the trial. This was due to good safety results. Subjects were not 
enrolled due to non-compatible clinical or laboratory screening results before enrollment for the 
trial. These data are in section 10.7.1 below. 

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10.4. 
Vaccinations/Treatments 
10.4.1. 
Vaccinations/Treatments Administered 
Two vaccines were administrated during this study. Two volunteers per cohort were 
vaccinated with conventional BCG full dose (2x105 CFU). Six volunteers per cohort were 
vaccinated with escalating doses of rBCG-N-hRSV (cohort A 5x103 CFU, cohort B 5x104  CFU, 
and cohort C 1x105 CFU). These vaccines were administered as an intradermal injection at study 
entry. 
10.4.2. 
Identity of Investigational Product(s) 
The study vaccine consisted of a novel, live attenuated,  recombinant Mycobacterium bovis 
BCG (Bacillus Calmette-Guérin), Danish strain 1331, expressing the nucleoprotein (N) from the 
human respiratory syncytial virus (hRSV serogroup A2, strain 13018-8, obtained from the Institute 
of Public Health of Chile (11)), called rBCG-N-hRSV. The vaccine was designed at the Pontificia 
Universidad Católica de Chile and manufactured under cGMP conditions at IDT Biologika (former 
AERAS TB Vaccine Foundation)(USA). 
10.4.3. 
Method of Assigning Subjects to Study Groups 
This phase I study was performed as a double blind, randomized trial. The study was 
organized in three groups, each including 8 subjects (total number of subjects was 24). Each group 
was created using the random.org software and the random-sequence-generator command for 8 
numbers (1 to 8). The first 6 numbers were assigned to the vaccine under study and the last 2 
numbers to the control vaccine. 
10.4.4. 
Selection of Doses in the Study 
The doses were selected according to the publications by Cautivo, K.M. et al and by 
Céspedes, P.C. et al. (14,15), which describe that 1x10^8 CFU and 3x10^5 CFU were used 
respectively to immunize mice, showing safety and efficacy in mice in both studies. Further, the 
current recommended dose for BCG was also considered as part of the dose selection 
(https://www.who.int/immunization_standards/vaccine_quality/118_bcg/en/). Because this was a 
first-in-human phase I trial to study a novel recombinant BCG vaccine designed to protect against 

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both, hRSV and Mycobacterium tuberculosis infections, a careful dose escalation trial was 
designed with safety monitoring between escalation groups. The dose escalation in the clinical 
trial began with 1/100th of the standard full dose licensed for infant BCG vaccination in Chile, then 
proceeded to 1/10th of the standard full dose licensed for infant BCG vaccination in Chile, and then 
proceeded to the standard full dose licensed for infant BCG vaccination in Chile.  
10.4.5. 
Selection and Timing of Dose for Each Subject 
This study followed a careful dose escalation strategy, with pauses by the DSMB to review 
the data after all subjects in each cohort had been evaluated for at least 30 days post-vaccination 
and before proceeding to the following escalation dose.  In cohorts A, B and C the doses of rBCG-
N-hRSV were 5x103 CFU, 5x104 CFU and 1x105 CFU, respectively. The BCG-WT dose for all 
control subjects was the same, which was the standard full dose (2x105 CFU) licensed for use in 
infants in Chile.  
10.4.6. 
Blinding 
This study was a double blinded study in which both, the participants and personnel were 
blinded to all the groups in the study. 
10.4.7. 
Prior and Concomitant Therapy 
NA 
10.4.8. 
Treatment Compliance 
N/A 
10.5. 
Efficacy/Immunogenicity and Safety Variables 
10.5.1. 
Safety Measurements Assessed and Flow Chart 
To assess the safety of the vaccine, a series of clinical tests to assess possible adverse events 
was performed. These tests can be seen in Table II. Adverse events (severe, local, general)  were 
recorded through day 180 and laboratory tests were performed at days 1, 2, 3, 7, 14, 30, 60, 120 
and 180 post-vaccination. 
 
 

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Table II: Safety and Efficacy/Immunogenicity evaluation. 
Safety test 
 
 
Clinical 
Local adverse events 
Pain, sensitivity (tenderness to touch) 
erythema, scab, induration, abscess 
and axillary lymphadenopathy 
General adverse events 
Fever, tachycardia, 
hypo/hypertension, headache, fatigue, 
myalgia, nausea/vomiting and 
diarrhea 
Laboratory 
Hematological 
Blood count (hemoglobin, 
leukocytes, neutrophils, lymphocytes 
and platelets count) 
Biochemical 
Transaminases, bilirubin, cholesterol, 
creatine, ureic nitrogen, plasmatic 
electrolytes, coagulation test, creatine 
phosphokinase and urine analyses 
 
10.5.2. 
Appropriateness of Measurements 
The above safety measurements were conducted to identify clinical symptoms or 
laboratory parameters that were uniquely related to the administration of the experimental rBCG-
N-hRSV vaccine. Unusual local systemic clinical reactions were documented, and laboratory 
evidence for renal, liver, hematologic disease adverse events were recorded.   
10.5.3. 
Primary Efficacy/Immunogenicity Endpoints 
NA 
10.5.4. 
Primary Safety Endpoints 
The primary safety endpoints of the study were the following: 

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Evaluation of reactogenicity (Local and systemics AE) 
- 
Evaluation of laboratory AE 
- 
Serious AE (SAE) 
- 
Evaluation of the presence of the BCG vaccine (wild-type and recombinant) in 
body fluids (blood, urine and saliva were cultured). 
10.5.5. 
 Secondary Efficacy/Immunogenicity and Safety Endpoints 
The secondary efficacy/immunogenicity and safety endpoints were the following: 
- 
Evaluation of the humoral and cellular immune responses against M. bovis 
BCG.  
- 
Evaluation of the humoral and cellular immune responses against hRSV. 
10.5.6. 
Drug Concentration Measurements 
NA 
10.6. 
Data Quality Assurance 
10.6.1. 
Data Collection and Management 
For the clinical and laboratory data collection, a handwritten and electronic Case Report 
File (CRF) was used for each visit. In addition, the local BCG lesion sites were photographed to 
document the local reactogenicity responses (pictures of the vaccine area were taken). 
To look for evidence of disseminated and/or persistent BCG infection vaccinated donors 
provided samples of blood, urine and saliva.  
For the cellular immunogenicity assays 20 ml of venous blood were collected in 
heparinized tubes (BD Vacutainer, New Jersey, USA), obtained from volunteers at day 0, 14, 30, 
60, 120 and 180 post-vaccination. The venous blood was purified by gradient centrifugation with 
Leukocyte Separation Medium (LSM, Corning, Virginia, USA) for 30 minutes at 20°C/300g. Cells 
were collected, washed twice with 1X PBS (Gibco, New York, USA), counted in a Neubauer 
chamber and then frozen with DMSO in liquid nitrogen. All samples were stored in a -150°C 
Ultrafreezer until the assays were performed. 

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For the humoral immunogenicity assays, 6 ml of venous blood were collected in non-
heparinized tubes (BD Vacutainer, New Jersey, USA), acquired from volunteers at day 0, 14, 30, 
60, 120 and 180 days post-vaccination. The venous blood was incubated vertically at room 
temperature for at least 30 minutes, then serum obtained by centrifugation for 15 minutes at room 
temperature in an Eppendorf centrifuge with a horizontal rotor at 1,500 g. 1.8 ml of serum were 
collected, aliquoted in 6 vials and frozen at -80°C (GlacierTM -86°C Ultra low Freezer) until the 
assays were performed. 
Assays to detect disseminated/persistent infection with the BCG vaccines included PCR 
and conventional culture, the cellular immunogenicity assays were assessed by ELISPOT and flow 
cytometry and the humoral immunogenicity assays were evaluated using indirect ELISA assays. 
These results were reported on specific study report forms 
10.6.1.1. Data Recording Methods 
The Source Documents used for documenting the clinical data were the institutional 
clinical records  at PUCC hospital and clinical evaluating unit and for the volunteers. In each study 
visit the anamnesis-clinical record/history for each subject, physical exam and all the study 
procedures as described above were collected on the CRF to properly inform the clinician about 
the individual health history. 
For the laboratory data, an electronic report issued by the clinical laboratory at PUCC 
hospital was generated. 
10.6.1.2. Subject Identifiers 
Each sample was identified with the number of each subject (i.e. the samples from RSV01 
were identified as RSV01) 
10.6.2. 
Monitoring, Auditing, and Archiving 
Once the healthy volunteers met the inclusion and exclusion criteria, the subjects received 
a single dose of the vaccine intradermally in the deltoid area. They were observed in the study 
clinic for the next 3 hours. Participants were evaluated at days 1, 2, 3, 7, 14, 30, 60, 120 and 180 
after vaccination. Follow-up phone calls were performed at days 4, 21, 45, 90 and 150 after 
vaccination. 

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10.6.3. 
Database Lock 
The staff of the clinical team entered information from each participant into an electronic 
CRF using a software called FMED (generated by the company “Brain Up”), which automatically 
organizes the data into a single coded excel file. 
10.7. 
Statistical Methods Planned in the Protocol and Determination of 
Sample Size 
10.7.1. 
Sample Size 
A total of 42 healthy males between ages 18 and 50 years of age were screened, and 24 
were enrolled and vaccinated with 8 participants in each cohort. Table III shows the number and 
age of participants that were screened and vaccinated. 
 
Table III: Subjects receiving investigational product. 
Subject number 
Age 
Received vaccine number 
Subject number 
Age 
Received vaccine number 
RSV01 
31 
CL01 
RSV22 
20 
NA 
RSV02 
32 
CL02 
RSV23 
25 
NA 
RSV03 
22 
CL03 
RSV24 
22 
CL12 
RSV04 
22 
NA 
RSV25 
44 
CL13 
RSV05 
21 
CL04 
RSV26 
25 
CL14 
RSV06 
35 
NA 
RSV27 
22 
CL15 
RSV07 
36 
CL05 
RSV28 
25 
NA 
RSV08 
26 
NA 
RSV29 
19 
NA 
RSV09 
22 
NA 
RSV30 
24 
CL16 
RSV10 
25 
CL06 
RSV31 
33 
NA 
RSV11 
27 
NA 
RSV32 
21 
CL17 
RSV12 
24 
NA 
RSV33 
21 
CL18 
RSV13 
20 
CL07 
RSV34 
21 
CL19 
RSV14 
34 
CL08 
RSV35 
20 
NA 
RSV15 
24 
NA 
RSV36 
25 
CL20 
RSV16 
24 
CL09 
RSV37 
29 
NA 
RSV17 
20 
CL10 
RSV38 
19 
CL21 
RSV18 
28 
CL11 
RSV39 
27 
NA 
RSV19 
48 
NA 
RSV40 
21 
CL22 
RSV20 
25 
NA 
RSV41 
21 
CL23 
RSV21 
21 
NA 
RSV42 
20 
CL24 
*NA: non applicable; CL-number: refers to the vaccine code received 
 
 
 

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10.7.2. 
Statistical Analysis Plan 
This was a phase I clinical trial to evaluate safety and was not statistically powered. For the 
clinical data obtained the Student´s t-test was used. For immunogenicity assays, statistical 
significance was assessed using One-way ANOVA with a posteriori Tukey test or Two-way 
ANOVA test with a posteriori Tukey test. 
 
11. 
STUDY SUBJECTS 
11.1. 
Disposition of Subjects 
Once inclusion criteria were met, volunteers were enrolled into three cohorts. Each cohort 
included 6 volunteers vaccinated with escalating doses of rBCG-N-hRSV (5x103 CFU; 5x104 
CFU; 1x105 CFU) and 2 volunteers vaccinated with the standard BCG (BCG-WT) (full dose of 
2x105 CFU). Figure 1 shows the clinical study flow diagram. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1: Clinical study flow diagram. The phase 1 study was a double blind dose ranging study. Each cohort included 6 
volunteers vaccinated with escalating doses of rBCG-N-hRSV (5 x 103 CFU; 5 x 104 CFU; 1 x 105 CFU) and 2 volunteers 
vaccinated with the standard BCG (BCG-WT) (2 x 105 CFU). Furthermore, the DSMB evaluated safety data of each cohort after 
the first 30 days of follow up and decided if escalation could continue. 
Cohort A 
7 screening failure 
Vaccinated  
n=8 
6 rBCG-N-hRSV 5x10^3  
2 BCG 2x10^5 
Cohort B 
7 screening failure 
Vaccinated 
n=8 
6 rBCG-N-hRSV 5x10^4  
2 BCG 2x10^5 
Cohort C 
4 screening failure 
Vaccinated 
n=8 
6 rBCG-N-hRSV 1x10^5  
2 BCG 2x10^5 
Day 30 safety analysis by 
CIMD 
Day 30 safety analysis by 
CIMD 
Day 30 safety analysis by 
CIMD 
180 days follow-up 
Study completion 
180 days follow-up 
180 days follow-up 
Study completion 
Study completion 

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Table IV show the disposition of subjects according to the cohort in which they were (from all the 
subjects including the ones that were excluded from the study). 
Table IV: Cohort by subject’s number. 
Cohort 
Subject number 
Cohort 
Subject number 
A 
RSV01 
B 
RSV22 
RSV02 
RSV23 
RSV03 
RSV24 
RSV04 
RSV25 
RSV05 
RSV26 
RSV06 
RSV27 
RSV07 
RSV28 
RSV08 
RSV29 
RSV09 
RSV30 
RSV10 
C 
RSV31 
RSV11 
RSV32 
RSV12 
RSV33 
RSV13 
RSV34 
RSV14 
RSV35 
RSV15 
RSV36 
B 
RSV16 
RSV37 
RSV17 
RSV38 
RSV18 
RSV39 
RSV19 
RSV40 
RSV20 
RSV41 
RSV21 
RSV42 
11.1.1. 
Demographic Data by Study Group 
The Table V show the demographic data of subjects according to study group (from all 
subjects including the ones that were excluded from the study). 
Table V: Demographic data by study group. 
Study group 
Age range 
Sex/Gender 
Cohort A 
20-36 
Male 
Cohort B 
20-44 
Cohort C 
19-25 
 
11.1.2. 
Summary of Prior and Concurrent Medical Conditions 
NA 
11.1.3. 
Study Visit Schedule 
 
The Table VI show the study visit schedule for the participants. 

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Table VI. Study visit Schedule 
 
11.1.4. 
Vital Signs Grading 
The vital signs were graded from 1 to 4. 
Table VII: Vital signs grading. 
Vital signs 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potential life risk 
(Grade 4) 
Fever (°C) (oral or 
axillary) 
38.0-38.4 
38.5-38.9 
39.0-40.0 
>40.0 
Tachycardia – beats 
per minute 
101-115 
116-130 
>130 
Emergency visit or 
hospitalization due to 
arrhythmia 

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Bradycardia – beats 
per minute 
50-54 
45-49 
< 45 
Emergency visit or 
hospitalization due to 
bradyarrhythmia  
Hypertension 
(systolic) – mmHg 
141-150 
151-155 
>155 
Emergency visit or 
hospitalization due to 
malignant 
hypertension 
Hypertension 
(diastolic) - mmHg 
91-95 
96-100 
>100 
Emergency visit or 
hospitalization due to 
malignant 
hypertension 
Hypotension 
(systolic) – mmHg 
85-89 
80-84 
< 80 
Emergency visit or 
hospitalization due to 
shock 
Respiratory 
frequency – breaths 
per minute 
17-20 
21-25 
>25 
Intubation 
 
11.2. 
Protocol Deviations 
Table VIII shows the protocol deviations for each subject, all of which took place during 
the eligibility exams. The deviations were reported to the institutional ethics committee and to the 
Data and Safety Monitoring Board (DSMB). 
The DSMB analyzed these deviations and requested additional information on the 
lymphocytic subpopulations. Upon review, the DSMB concluded that the protocol deviations did 
not have any impact on the safety of the subjects and recommended that the study continue.  
 
Table VIII: Protocol deviation by each subject 
Subject 
Deviation 
Corrective action 
RSV01 
Albumin at baseline (eligibility tests) out of the range indicated in 
amendment 2 (5.1 mg/dl, value indicated is 3.5-5.0) 
All study personnel were 
trained to rigorously adhere 

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RSV01 
Cholesterol at baseline (eligibility tests) out of the range indicated in 
amendment 2, 200 mg/dl (the amendment 2 indicated, by mistake, the 
normal value is <200, being ≤200 correct) 
to 
the 
values 
of 
the 
laboratory 
RSV01 
Missing values for CD16 or CD56/19 in the lymphocytic populations at 
baseline (eligibility tests) 
The laboratory was trained 
to report these values of the 
study subjects 
RSV02 
Missing values for CD16 or CD56/19 in the lymphocytic populations at 
baseline (eligibility tests) 
RSV03 
Missing values for CD16 or CD56/19 in the lymphocytic populations at 
baseline (eligibility tests) 
RSV05 
Missing values for CD16 or CD56/19 in the lymphocytic populations at 
baseline (eligibility tests) 
RSV07 
Missing values for CD16 or CD56/19 in the lymphocytic populations at 
baseline (eligibility tests) 
RSV25 
From day 9, the subject did not register appropriately the measurements for 
erythema and induration, but all of these were less than 25 mm 
The subject and study 
personnel were retrained to 
ensure these measurements 
were performed until day 30 
RSV27 
In Visit 6 (day 14 post-vaccination) the PT and PTT were not measured. 
Study 
personnel 
were 
retrained on the correct 
tubes to be used for these 
measurements 
RSV 36 
Visit 7, 1 day out of the window period 
 
 
The subject was further 
educated 
as 
to 
the 
importance of following 
study procedures 
12. 
EFFICACY/IMMUNOGENICITY EVALUATION 
12.1. 
Analysis Populations 
The population analyzed were healthy male adults, between 18 and 50 years of age. 
12.2. 
Demographics and Other Baseline Characteristics 
The participants were healthy Chilean males 18 to 50 years old, who were vaccinated with 
BCG once or twice during their life, prior to study participation. The information was recording 
by an objective evaluation of the BCG vaccination scar or scars in each subject. It is not possible 
to determine which BCG strain the participant received previous to this study, because the Chilean 
Government obtain different vaccines from different sources (Statens Serum Institut or Serum 
Institute of India) 

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12.2.1. 
Prior and Concurrent Medical Conditions 
The subjects were healthy and tested negative for human immunodeficiency virus (HIV), 
hepatitis B surface antigen (HBsAG) and hepatitis C virus (HCV), and had no evidence of primary 
or secondary immunodeficiency. 
12.2.2. 
Prior and Concomitant Medications 
The subjects had to meet the inclusion and exclusion criteria prior to enrolling in the trial. 
Prior to the study, the subjects were not allowed to use inhaled corticosteroids or 
immunosuppressors, had not received treatment for tuberculosis or other mycobacteria, had not 
used illegal drug substances and had not been administered immunoglobulins or blood-derived 
products. 
12.3. 
Measurements of Treatment Compliance 
Since the treatment is an immunization with a single dose of either, control BCG vaccine 
provided by the Ministry of Health in Chile (Serum Institute of India, Bacillus Calmette Guerin 
Moscow strain 361- I) or rBCG-N-hRSV, no measurements of treatment compliance were 
required. 
12.4. 
Efficacy/Immunogenicity Results and Tabulations of Individual 
Subject Data 
12.4.1. 
Methodology and Primary Statistical Analysis of Efficacy/ Immunogenicity Data 
The immune responses were measured as follows: Peripheral blood mononuclear cells 
(PBMC) and serum samples from twenty four subjects were collected on visits 1 (day 0), 6 (day 
14), 7 (day 30) and 10 (day 180) post-vaccination and stored.  The 24 subjects were divided in 
three groups of 8 according to the dose of rBCG-N-hRSV used: Cohort A (5x103 CFU), cohort B 
(5x104 CFU) and cohort C (1x105 CFU). To evaluate the cellular response, the cells obtained from 
peripheral blood were thawed, counted and stimulated in vitro with PPD and N-RSV antigens to 
measure the antigen-specific immune response. Total cells that secreted IL-2 and/or  IFN-γ were 
measured by ELISPOT and cellular subpopulations of CD4+ / CD8+ producers of IL-2+ IFN-γ were 
measured by flow cytometry. To evaluate the humoral response, sera were thawed and incubated 
in pre-activated ELISA plates with PPD and N-RSV antigens. Afterwards, they were incubated 

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with human anti-IgG secondary antibody conjugated to horseradish peroxidase (HRP). The 
specific immunoglobulins against PPD and N-RSV were quantified using a standard curve with 
the humanized anti-F antibody (Palivizumab). The results were obtained based on the absorbance 
of the product generated by the anti-IgG HRP antibody and TMB substrate (3,3′,5,5′-
Tetramethylbenzidine) in a spectrophotometer. 
All statistical analyses for the immunogenicity assays were performed using GraphPad 
Prism version 7.0 Software. Statistical significance was assessed using One-way ANOVA with a 
posteriori Tukey test, or two-way ANOVA test with a posteriori Tukey test. 
12.4.1.1. Handling of Dropouts or Missing Data 
Data for some time points for ELISPOT evaluation in cohort A was missing, as described 
in table V. 
12.4.2. 
Tabulation of Individual Response Data 
 
Table IX: Immunogenicity Individual Response 
  
  
  
  
  
  
  
  
  
IFN-y and IL-2 SFC/million cells against PPD 
IFN-y and IL-2 SFC/million cells against hRSV N protein 
  
BCG-WT 2x105 
  
VRS01 
VRS 13 
VRS18 
VRS24 
VRS34 
VRS38 
VRS01 
VRS 13 
VRS18 
VRS24 
VRS34 
VRS38 
0 dpi 
0 
23.3 
110 
10 
60 
123.3 
0 
0 
13.3 
0 
0 
0 
14 dpi 
23.3 
  
103.3 
3.3 
63.3 
196.7 
0 
* 
* 
0 
0 
6.7 
30 dpi 
120 
73.3 
140 
3.3 
86.7 
120 
10 
3.3 
0 
0 
0 
3.3 
60 dpi 
86.7 
130 
126.7 
33.3 
73.3 
110 
3.3 
3.3 
0 
0 
3.3 
0 
120 dpi 
70 
96.7 
256.7 
46.7 
6.7 
113.3 
10 
0 
6.7 
0 
0 
10 
180 dpi 
53.3 
6.7 
160 
93.3 
0 
56.7 
3.3 
0 
3.3 
3.3 
3.3 
0 
  
COHORT A 
  
VRS02 
VRS03 
VRS05 
VRS07 
VRS10 
VRS14 
VRS02 
VRS03 
VRS05 
VRS07 
VRS10 
VRS14 
0 dpi 
* 
36.7 
90 
20 
70 
266.7 
* 
3.3 
46.7 
0 
0 
16.7 
14 dpi 
* 
* 
* 
36.7 
  
200 
* 
* 
* 
3.3 
* 
13.3 
30 dpi 
* 
150 
33.3 
110 
263.3 
126.7 
* 
0 
16.7 
3.3 
0 
6.7 
60 dpi 
56.7 
50 
10 
33.3 
156.7 
66.7 
0 
0 
3.3 
10 
0 
3.3 
120 dpi 
6.7 
146.7 
40 
83.3 
83.3 
143.3 
0 
10 
20 
0 
0 
0 
180 dpi 
23.3 
70 
13.3 
46.7 
16.7 
43.3 
0 
0 
13.3 
6.7 
0 
0 
  
COHORT B 
  
VRS16 
VRS27 
VRS17 
VRS25 
VRS26 
VRS30 
VRS16 
VRS27 
VRS17 
VRS25 
VRS26 
VRS30 
0 dpi 
33.3 
0 
90 
20 
46.7 
10 
10 
0 
6.7 
0 
6.7 
10 
14 dpi 
106.7 
253.3 
236.7 
13.3 
63.3 
46.7 
6.7 
0 
3.3 
0 
0 
3.3 
30 dpi 
106.7 
306.7 
300 
60 
136.7 
46.7 
6.7 
0 
3.3 
3.3 
23.3 
6.7 
60 dpi 
180 
413.3 
216.7 
146.7 
106.7 
20 
6.7 
16.7 
3.3 
3.3 
10 
3.3 

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120 dpi 
93.3 
176.7 
143.3 
6.7 
90 
13.3 
10 
13.3 
0 
0 
3.3 
0 
180 dpi 
100 
100 
113.3 
73.3 
50 
13.3 
0 
0 
0 
3.3 
10 
0 
  
COHORT C 
  
VRS32 
VRS33 
VRS36 
VRS40 
VRS41 
VRS42 
VRS32 
VRS33 
VRS36 
VRS40 
VRS41 
VRS42 
0 dpi 
6.7 
43.3 
110 
46.7 
10 
440 
0 
6.7 
23.3 
46.7 
10 
0 
14 dpi 
66.7 
276.7 
180 
153.3 
26.7 
543.3 
0 
0 
56.7 
46.7 
10 
6.7 
30 dpi 
103.3 
126.7 
166.7 
106.7 
13.3 
340 
6.7 
3.3 
66.7 
33.3 
16.7 
10 
60 dpi 
50 
46.7 
20 
70 
16.7 
223.3 
3.3 
3.3 
3.3 
46.7 
6.7 
3.3 
120 dpi 
16.7 
36.7 
383.3 
103.3 
0 
76.7 
0 
3.3 
0 
46.7 
10 
23.3 
180 dpi 
36.7 
73.3 
280 
63.3 
0 
116.7 
6.7 
13.3 
3.3 
36.7 
13.3 
23.3 
*Missing data 
dpi: Days post-immunization. 
12.4.3. 
Efficacy/Immunogenicity Conclusions 
Cellular immunogenicity measurements showed that 14 days after vaccination all 
volunteers increased cellular production of IFN-γ and IL-2 upon in vitro stimulation with PPD 
antigen by ELISPOT (Figure 2). The cellular response against the RSV N protein was increased 
30 days after vaccination, indicating the induction of a specific immune response against antigens 
included in the vaccine. 
 
Figure 2: Measurement of the specific cellular response by ELISPOT against the PPD antigens (in black) and N protein (in 
white) of the human respiratory syncytial virus. The results are expressed as the fold change (log2) with respect to visit 1 (day 
0) for IFN-g and IL-2 secretory cells at times 14, 30 and 180 days after vaccination for the three doses of rBCG-N-hRSV (5x10^3 
CFU, 5x10^4 CFU, 1x10^5 CFU) and for BCG-WT (2x10^5 CFU). 
 

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Furthermore, the amount of specific IgG response against PPD and N in the serum 
increased 60 days post-vaccination (Figure 3). In summary, rBCG-N-hRSV showed a good safety 
profile in healthy adults and induced specific cellular and humoral immune responses. 
 
 
Figure 3: Measurement of the specific humoral immune response by indirect ELISA assay against the N protein (in white) 
and PPD antigens (in black) of the human respiratory syncytial virus. The result is expressed in fold change (log10) with 
respect to visit 1 (day 0) in the detection of specific IgG at times 60, 120 and 180 days after vaccination for the three doses of 
rBCG- N-hRSV (5x10^3 CFU, 5x10^4 CFU, 1x10^5 CFU) and for BCG-WT (2x10^5 CFU). 
 
13. 
SAFETY EVALUATION 
13.1. 
Extent of Exposure 
From the total of 24 participants, there were 524 adverse events. 
13.2. 
Adverse Events (AEs) 
13.2.1. 
Brief Summary of Adverse Events 
Overall, 524 adverse events were registered for the 24 participants: 244 local adverse 
events (46.6%), 157 general adverse events (30.0%) and 123 laboratory adverse events (23.5%). 
Importantly, no participants were discontinued due to an AE. The most frequent local solicited 
adverse events were abscess, scabbing and tenderness at the BCG injection sites, occurring in all 
participants. The most common solicited adverse events were headache, fatigue, diarrhea and 
myalgia. As for the laboratory adverse events (as defined by a significant deviation from normal 
ranges for laboratory tests), 56.9% were classified as not related to vaccine and 43.1% as possibly 
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
1
10
100
1000
10000
Fold change (log10) 
N
IgG 
60 Days
PPD
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
1
10
100
1000
Fold change (log10) 
N
PPD
IgG 
120 Days
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
BCG-WT
rBCG-N-103
rBCG-N-104
rBCG-N-105
1
10
100
316.2
1000
Fold change (log10) 
N
PPD
IgG 
180 Days

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related to vaccine because no definitive etiology was found. The most common laboratory adverse 
event was decreased hemoglobin (see Table XII). 
13.2.2. 
Display of Adverse Events 
A severe laboratory adverse event (SAE) G4 was presented during the study of cohort C. 
This event relates to subject RSV34 that on day 14 (December 06 2017), while being 
asymptomatic, presented a rise in CPK values (20.488 U/L). The subject did intense exercise at 
the gym on December 03th, 2017 for 1.5 hour, resulting in fatigue at the end of his exercise and 
myalgias for the next few days. This was accompanied by a grade 3 rise in SGOT (276 U/L). On 
December 11, 2017 the subject was found to have a CPK of 3.827 U/L and SGOT of 186 U/L. On 
visit day 30 (December 21, 2017), both values had normalized (CPK 134 U/L and SGOT 18 U/L). 
The SAE from this study are shown in Table VI. This event was considered to be unrelated to the 
study vaccine, by the investigator as well as the sponsor’s security delegate, Dr. Fernando 
Altermatt. The SAE was reported to the institutional ethics committee (CEC-MedCUC) and to the 
sponsor’s security delegate, who notified the Institute for Public Health of Chile (Instituto de Salud 
Pública de Chile). 
 
Table X: SAE from the three cohorts, at January 8 2018, completion of day 30 post vaccination Cohort C 
Cohort 
SAEs 
SAE type 
Relation with the 
vaccine 
Final Disposition 
A 
0 
None 
None 
None 
B 
0 
None 
None 
None 
C 
1 
Grade 4 rise of  CPK 
Not related 
Resolved 
Total 
1 
Laboratory abnormality 
Not related 
All resolved 
 
Clinical adverse events (CAE) were presented at day 30 and are shown in Table XI. A rise 
of local AEs was observed in cohort B as compared to cohort A, and in cohort C as compared to 
cohort B, being significant only for the difference between cohort A and C (p=0.04 test U Mann 
Whitney). As for the total AEs, there were no significant differences between cohorts.  

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Table XI: Clinical Adverse Events Cohorts A, B and C, at day 30 at January 8 2018, completion of day 30 post 
vaccination Cohort C 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Solicited local AE 
51 
70 
83 
204 
Non solicited local AE 
8 
6 
8 
22 
Subtotal local AE 
59 
76 
91 
226 
Solicited general AE 
21 
19 
28 
68 
Non solicited general AE 
15 
2 
11 
28 
Subtotal general AE 
36 
21 
39 
96 
Total AE 
95 
97 
130 
322 
 
Clinical adverse events (CAE)  identified by January 8th 2018, which is completion of 
day 30 post vaccination of Cohort C, are shown in table XII. 
 
Table XII: Clinical adverse events for Cohorts A, B and C at the day of the inform (January 8th 2018) , completion of 
day 30 post vaccination Cohort C. 
 
Event 
Cohort A 
Day 150-180 
Cohort B 
Day 60 
Cohort C 
Day 30 
Total 
Solicited local AE 
57 
72 
83 
212 
Non solicited local AE 
11 
6 
8 
25 
Subtotal local AE 
68 
78 
91 
237 
Solicited general AE 
22 
20 
28 
70 
Non solicited general AE 
38 
6 
11 
55 
Subtotal general AE 
60 
26 
39 
125 
Total AE 
128 
104 
130 
258 
 

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13.2.2.1. Solicited AEs 
Clinical solicited adverse events were followed through day 30 post-vaccination. Local 
solicited AE included pain, sensitivity, erythema, scab, induration, abscess and axillary 
lymphadenopathy. General solicited AE included fever, tachycardia, hypo/hypertension, 
headache, fatigue, myalgia, nausea/vomiting and diarrhea. Local solicited grade 3 AE were 
identified only in cohort C, and included 2 grade 3 reactions (1 pain and 1 sensitivity) at the 
vaccination site. Both events were resolved.  
Table XIII: Solicited general adverse events grade 3. The number of low, moderate and severe events per cohort and per 
type of event is shown in the Table. The vital risk events are not included in this Table. 
 
13.2.2.2. Unsolicited AEs 
Clinical unsolicited adverse events were recorded through day 30. The episodes of high 
blood pressure and tachycardia did not occur in the period immediately after vaccination, but at 
the beginning of subsequent visits. In Cohort A, these measurements were not repeated by the 
staff. In Cohort B, these measurements were repeated and the values were repeatedly high. 
 
 
 
Event 
Cohort A 
Cohort B 
 
Cohort C 
low 
moderate 
severe 
low 
moderate 
severe 
low 
moderate 
severe 
Headache 
3 
0 
0 
0 
0 
0 
9 
2 
0 
Fatigue 
2 
0 
0 
3 
0 
0 
4 
1 
0 
Nausea/vomiting 
7 
2 
0 
5 
1 
0 
4 
0 
0 
Diarrhea 
6 
0 
0 
4 
0 
0 
5 
0 
0 
Myalgia 
1 
0 
0 
 6 
0 
0 
3 
0 
0 
Fever 
0 
0 
0 
0 
0 
0 
0 
0 
0 
TOTAL 
19 
2 
0 
18 
1 
0 
25 
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0 

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Table  XIV: Number of Non-Solicited Clinical Adverse events. 
Event 
Cohorts A 
(5x10^3) 
Cohorts A 
(5x10^4) 
Cohorts A 
(1x10^5) 
Control BCG 
WT 
(2x10^5) 
TOTAL 
Viral upper respiratory 
infection 
4 
4 
7 
3 
18 
Headache 
1 
2 
0 
14 
17 
Other events respiratory 
tract 
7 
0 
3 
1 
11 
Diarrhea/gastroenteritis 
1 
0 
4 
0 
5 
Toothache 
3 
0 
0 
0 
3 
Ecchymosis injection site 
1 
0 
1 
0 
2 
Bruise on hand 
1 
0 
1 
0 
2 
Contusion of hand/wrist 
0 
0 
1 
1 
2 
Cellulitis tight 
0 
1 
0 
1 
2 
Muscular contraction back 
0 
1 
0 
1 
2 
Abdominal pain 
0 
0 
0 
1 
1 
Arterial hypertension 
0 
0 
1 
0 
1 
Foot injury due to beat 
0 
0 
0 
1 
1 
General malaise 
0 
0 
1 
0 
1 
Urethritis 
0 
0 
1 
0 
1 
Urticaria 
0 
0 
1 
0 
1 
Sclap ache 
0 
0 
1 
0 
1 
Retro ocular ache 
1 
0 
0 
0 
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13.2.3. 
Analysis of Adverse Events 
There were more solicited local grade 2 and grade 3 clinical AEs (severe and moderate) in 
Cohort B and C compared to Cohort A (p = 0.012 and p = 0.001, respectively), but there were no 
significant differences between Cohort B and Cohort C (p = 0.362): Cohort A (3/51 = 5.9%), 
Cohort B (16/70 = 22.9%), Cohort C (25/83 = 30.1%). There were no significant differences in the 
solicited general AEs between cohorts, and therefore there was no association with increasing 
doses of the study vaccine. There were no significant differences in unsolicited clinical AEs 
between the groups.  
The listing of local adverse events by subjects, can be seen in Table XXV (annex). 
 
The listing of general adverse events by subjects, can be seen in Table XXVI (annex). 
 
13.3. 
Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events 
13.3.1. 
Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse 
Events 
No deaths occurred in any study subject during the trial observation period. 
Fever 
1 
0 
0 
0 
1 
Epistaxis 
0 
0 
0 
1 
1 
Nausea 
0 
0 
1 
0 
1 
Ansiety 
0 
0 
1 
0 
1 
Insomnia 
0 
0 
1 
0 
1 
Myalgia 
0 
0 
1 
0 
1 
Leg pain 
0 
0 
0 
1 
1 
Scratch in vaccination site 
1 
0 
0 
0 
1 
TOTAL 
20 
6 
25 
25 
76 

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Two Serious Adverse Events were registered during the study. 
13.3.1.1. Deaths 
No deaths were occurred in this study. 
13.3.1.2. Serious Adverse Events 
The listing of serious adverse events, can be seen in Table XV. 
Table XV: Serious adverse events. 
Subject 
Age 
Diagnosis 
Vaccination 
Date 
Start Date 
(days post-
vaccination) 
Resolution Date 
(days post-vaccination) 
Severity 
Criterion 
Vaccine 
Assigned 
Cause 
Related to 
vaccination
RSV34 
22 
Increase in CPK 
21-11-17 
17 
31 
Lab AE G4 
Control 
Intense 
exercises 
the day 
before 
No 
RSV42 
20 
Precordial pain 
secondary to 
Supraventricular 
Tachycardia 
04-12-17 
51 
53 
Hospitalization 
5x105 
Previous 
pre-
excitation 
syndrome 
No 
 
13.3.1.3. Other Significant Adverse Events 
NA 
13.3.2. 
Narratives of Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events 
There were no deaths.  
RSV34: 
One SAE laboratory grade 4 AE occurred in subject RSV34 enrolled in cohort C, who was 
vaccinated on day November 21st, 2017 and on day 14 (December 06th, 2017 17 days after 
vaccination) presented to the clinic and was found to have  an asymptomatic grade 4 increase in 
CPK (20,488 U/L). The subject had engaged in intense exercise at a gym on December 03, 2017 
for 1.5 hours, and experienced  marked fatigue at the end of the exercise and myalgia for the next 
few days. This was associated with a grade 3 increase in SGOT (276 U/L). At follow up on 

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December 11, 2017, the subject was found to have decreased levels of CPK (3,827 U/L) and SGOT 
(186 U/L). At his next scheduled visit on day 30 post-vaccination (December 21, 2017) both values 
had normalized (CPK of 134 U/L and SGOT of 18 U/L). The events were considered not to be 
related to the study vaccine by both, the investigator and the security delegate sponsor, Dr. 
Fernando Altermatt. The SAE was reported to the institutional ethic committee (CEC-MedUC) 
and the security delegate sponsor  notified the Instituto de Salud Pública de Chile (ISP). The event 
was not related to the vaccination. 
 
RSV42: 
A second subject was hospitalized on January 25th, 2018  (51 days post vaccination) when 
he presented precordial pain beginning the night before. At the hospital, his EKG was essentially 
normal (only abnormality was a delta wave compatible with pre-excitation, which was a previous 
condition identified in the patient). However, he was found to have elevated cardiac enzymes.  
Echocardiogram findings were normal. The physicians determined that the precordial pain was 
most likely secondary to a supra-ventricular tachycardia  due to a pre-existing pre-excitation 
pathway that had been diagnosed when the subject was an infant. The final diagnosis for this SAE 
was pre-cordial pain secondary to a supra-ventricular tachycardia due to a pre-existing pre-
excitation syndrome. The event was resolved the day of his medical release (January 26, 2018, day 
53 post-vaccination). The event was not related to the vaccination. 
13.3.3. 
Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other 
Significant Adverse Events 
According to the narrative, the Serious Adverse Events detected were not related to 
immunization. No deaths were reported in this study. 
13.4. 
Clinical Laboratory Evaluation 
13.4.1. 
Individual Laboratory Measurements and Abnormal Laboratory Values 
Laboratory adverse events (LAE) are presented in table XVI. No significant differences 
were observed comparing the 3 cohorts. 
 

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Table XVI: Laboratory adverse events from cohort A, B and C at day January 8th, 2018( 30 days after Cohort C 
vaccination) 
 
Cohort A 
Cohort B 
Cohort C 
Event 
Total 
Grade 
1/2/3 
Total 
Grade 
1/2/3 
Total 
Grade 
1/2/3 
Decrease of Hb 
7* 
5/1/1 
5** 
5/0/0 
8 
7/1/0 
Increase in CPK 
6 
3/2/1 
2 
2/0/0 
4 
2/2/0 
Leukopenia 
5# 
5/0/0 
1 
1/0/0 
0 
NA 
Increase in cholesterol 
2 
2/0/0 
1 
1/0/0 
0 
NA 
Proteinuria$ 
2 
0/2/0 
1 
1/0/0 
1 
1/0/0 
Leukocytosis 
1 
1/0/0 
0 
NA 
0 
NA 
Neutropenia 
1 
0/1/0 
0 
NA 
0 
NA 
Increased SGOT or SGPT 
1 
1/0/0 
1 
1/0/0 
1 
0/0/1 
Hypoproteinemia 
1 
1/0/0 
0 
NA 
0 
NA 
Hyperglycemia& 
1 
1/0/0 
0 
NA 
0 
NA 
Hypophosphatemia 
1 
1/0/0 
1 
1/0/0 
1 
1/0/0 
Increase in prothrombin 
1 
1/0/0 
0 
NA 
0 
NA 
Pyuria 
0 
NA 
1 
1/0/0 
2 
1/1/0 
Eosinophilia 
0 
NA 
1 
1/0/0 
1 
1/0/0 
Hematuria 
0 
NA 
0 
NA 
1 
0/1/0 
Increased LDH 
0 
NA 
0 
NA 
1 
1/0/0 
Hypokalemia 
0 
NA 
0 
NA 
1 
1/0/0 
Increase alkaline phosphatases 
0 
NA 
0 
NA 
1 
1/0/0 
Total 
29 
22/5/2 
14 
14/0/0 
22 
16/5/1 
*7 episodes in 6 subjects, **5 episodes in 4 subjects. Two recovered and presented again. 
#5 episodes in 4 subjects, one recovered and presented again. 
$Proteinuria +- is considered mild and +, moderate 
&Patient was not fasting 
There was no relation of frequency and intensity of some laboratory AE with the type of vaccine received. 

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13.4.2. 
Evaluation of Each Laboratory Parameter 
Hematological and biochemical parameters were measured at days 7, 14, 30, 60, 120 and 
180 post-vaccination. 
13.4.2.1. Laboratory Values over Time  
All grade 3 events reported decreased over time. 
13.4.2.2. Individual Subject Changes 
Subject RSV01 presented 3 grade 3 events and only 2 of them returned to normal values. 
Subject RSV14 presented 1 grade 3 event and at day 30 was back to normal. Subject RSV25 
presented 1 grade 3 events and at day 60 it continued as a grade 3. It normalized at visit 10 (day 
180 post vaccination). Finally, subject RSV34 presented 2 events which at day 30 were back to 
normal. 
Table XVII: Grade 3 laboratory adverse events and follow-up  
N 
Cohort 
Event 
(Subject) 
Association 
with the 
vaccine 
Visit 
when 
event 
presented 
Evolution over 
time 
Clinical 
Manifestation  
Observations  
1 
A 
Hb decreased 
(RSV01) 
Likely.  
Alternative 
cause: blood 
samples  
V5 
(Day 
7) 
Basal:    17.4 
Day 07:  15.9 (G1) 
Day 14:  15.1 (G3) 
Day 30:  15.2 (G3) 
Day 60:  16.7 (G1) 
None 
Initial Hb was 
above the upper 
limit (17.4) 
because of 
potential 
dehydration at 
enrollment.  
 
The participant 
did not have 
anemia. 
2 
A 
CPK increased 
(RSV14) 
Likely.  
Alternative 
cause: 
exercise in 
V5 
(Day 
7) 
Day 7:  972 (G3) 
Day 14: 168 (N) 
Day 30: 126 (N) 
None 
Limit values 
established by 
PUCC were twice 
those established 
by the USA and 
France. Taking 

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previous 
days 
this information 
into 
consideration, the 
AE corresponds 
to Grade 2. 
3 
A 
Hematuria 
(RSV01) 
Likely. 
Alternative 
cause: micro 
lithiasis 
V8 
(Day 
60) 
Day 60: 170 GR 
(G3) 
Day 62: 14 GR 
(G1) 
Day 120: 4 GR (N) 
None 
Family history of 
lithiasis. Culture 
negative. 
4 
A 
Hypernatremia 
Likely. 
Alternative 
cause: 
dehydration 
by fasting 
V9 
(Day 
120) 
Day 
60: 
150 
mEq/L (G3) 
Day 
62: 
143 
mEq/L (N)  
None 
Normal repeated 
fasting  
5 
B 
Hypophosphatemia 
(RSV25) 
Likely. 
Alternative 
cause: Low 
ingestion of 
phosphorus 
V8 
(Day 
60) 
Day 60: 1.8 mEq/L 
(G3) 
None 
At day 7 shows 
Grade 1, 
normalized at day 
14. 
6 
C 
CPK 
increased 
(RSV34) 
Unrelated. 
Alternative 
cause: 
extreme 
exercise 
V6 
(Day 
14) 
Day 14:20.488 U/L 
(G4) 
Day 19: 3.827 U/L 
(G3) 
Day 30: 134 U/L 
(N) 
None 
Normal at day 30 
(V7) 
7 
C 
SGTO 
increased 
(RSV34) 
Unrelated. 
Alternative 
cause: 
exercise 
in 
previous 
days 
V6 
(Day 
14) 
Day 14: 276 U/L 
(G3) 
Day 19: 186 U/L 
(G2) 
Day 30: 18 U/L (N) 
None 
Normal at day 30 
(V7) 

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13.4.2.3. Displays of Laboratory Results 
13.4.2.4.  Chemistry Results 
The biochemistry results from the 3 laboratory Cohorts, can be seen in Table XVIII. 
 
Table XVIII: Biochemistry results from all laboratory cohorts. The total number of non-solicited clinical adverse events is 
shown per cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-
moderate/3-severe) is shown in the Grades column. 
 
 
 
 
 
 
 
 
 
 
*7 episodes in 6 subjects, one recovered and presented again 
**6 episodes in 5 subjects, one recovered and presented again. 
 
13.4.2.5. Hematology Results 
The hematology results from the 3 laboratory Cohorts, can be seen in Table XIX. 
Table XIX: Hematology results from all laboratory cohorts. The total number of non-solicited clinical adverse events is 
shown per cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-
moderate/3-severe) is shown in the Grades column. 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
1/2/3 
Total 
Grades 
1/2/3 
Total 
Grades 1/2/3 
Hb decreased 
 7* 
5/1/1 
6** 
6/0/0 
8 
7/1/0 
CPK increased 
6 
3/2/1 
2 
2/0/0 
4 
2/2/0 
Alkaline phosphatases 
0 
NA 
0 
NA 
1 
1/0/0 
TOTAL 
13 
8/3/2 
8 
8/0/0 
13 
10/3/0 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
1/2/3 
Total 
Grades 
1/2/3 
Total 
Grades 1/2/3 
Leukopenia 
   5# 
5/0/0 
1 
1/0/0 
0 
NA 
Cholesterol increased 
2 
2/0/0 
1 
1/0/0 
0 
NA 

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 # 5 episodes in 4 subjects, one recovered and presented again 
 
The hematology results from the 3 clinical Cohorts, can be seen in Table XX. 
Table XX: Hematology results from all 3 clinical cohorts. The total number of non-solicited clinical adverse events is shown 
per cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-moderate) 
is shown in the Grades column.  
Leukocytosis  
1 
1/0/0 
0 
NA 
0 
NA 
Neutropenia 
1 
0/1/0 
0 
NA 
0 
NA 
SGOT 
or 
SGPT 
increased 
1 
1/0/0 
1 
1/0/0 
1 
0/0/1 
Hypoproteinemia 
1 
1/0/0 
0 
NA 
0 
NA 
Hyperglycemia & 
1 
1/0/0 
0 
NA 
0 
NA 
Hypophosphatemia 
1 
1/0/0 
1 
1/0/0 
1 
1/0/0 
Prothrombin 
time 
increased 
1 
1/0/0 
0 
NA 
0 
NA 
Leucocituria 
0 
NA 
1 
1/0/0 
2 
1/1/0 
Eosinophilia 
0 
NA 
1 
1/0/0 
1 
1/0/0 
LDH increase 
0 
NA 
0 
NA 
1 
1/0/0 
Hypokalemia 
0 
NA 
0 
NA 
1 
1/0/0 
TOTAL 
14 
13/1/0 
6 
6/0/0 
7 
5/1/1 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
Total 
Grades 
Total 
Grades 
Viral upper respiratory infection* 
5 
5/0 
1 
1/0 
2 
2/0 
Other events respiratory system 
and ORL 
3 
0/3 
0 
NA 
1 
1/0 
Lipothymia 
 
due 
to 
blood 
sampling 
1 
0/1 
0 
NA 
0 
NA 

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13.4.2.6. Urinalysis Results 
The urinalysis results from the 3 laboratory Cohorts, can be seen in Table XXI. 
Table XXI: Urinalysis results from all laboratory cohorts. The total number of non-solicited clinical adverse events is 
shown per cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-
moderate/3-severe) is shown in the Grades column.  
 
 
 
 
 
 
 
 
 
The urinalysis results from the 3 clinical Cohorts, can be seen in Table XXII. 
 
Table XXII: Urinalysis results from all clinical cohorts. The total number of non-solicited clinical adverse events is shown 
per cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-moderate) 
is shown in the Grades column.  
 
 
 
 
 
 
 
 
 
TOTAL 
9 
5/4 
1 
1/0 
3 
3/0 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
1/2/3 
Total 
Grades 
1/2/3 
Total 
Grades 1/2/3 
Proteinuria$ 
2 
0/2/0 
1 
1/0/0 
1 
1/0/0 
Hematuria 
0 
NA 
0 
NA 
1 
0/1/0 
TOTAL 
2 
0/2/0 
1 
1/0/0 
2 
1/1/0 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
Total 
Grades 
Total 
Grades 
Urethritis 
0 
NA 
0 
NA 
1 
1/0 
TOTAL 
0 
NA 
0 
NA 
1 
1/0 

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13.5. 
Vital Signs, Physical Exam Findings, and Other Observations 
Related to Safety 
13.5.1. 
Vital Signs Grading 
The vital signs from the 3 clinical Cohorts, can be seen in Table XXIII. 
Table XXIII: Vital signs from all clinical cohorts. The total number of non-solicited clinical adverse events is shown per 
cohort (“Total” column). Also, the number of subjects that were categorized under a specific grade (1-low/2-moderate) is 
shown in the Grades column. 
13.5.2. 
Abnormal Vital Signs 
The abnormal vital signs can be seen in table XXIV. 
Table XXIV: Abnormal vital signs.  
* rBCG-N-hRSV (1) or WT-BCG (2).  
**AE number indicates the relative total AE numbers registered up to the point of that AE.  
*** local solicited AE (1), local non-solicited AE (2), general solicited AE (3), general non-solicited AE (4), laboratory registered 
AE (5). 
Event 
Cohort A 
Cohort B 
Cohort C 
Total 
Grades 
Total 
Grades 
Total 
Grades 
Arterial hypertension 
2 
2/0 
1 
1/0 
0 
NA 
Tachycardia  
1 
1/0 
0 
NA 
0 
NA 
Systolic hypotension 
0 
NA 
0 
NA 
2 
1/1 
TOTAL 
3 
3/0 
1 
1/0 
2 
1/1 
Subject 
N° 
Cohort 
Vaccine 
Type* 
Vaccine 
Dose 
AE 
N°*
** 
Diagnosis 
AD 
Type 
*** 
 
Vaccination 
day 
AE 
Starts (day post 
vaccination) 
AE 
Ends(day post 
vaccination) 
RSV03 
Cohort A 
1 
5x103 
22 
Tachycardia 
3 
1 
1 
1 
RSV05 
Cohort A 
1 
5x103 
2 
Hypertension 
3 
2 
2 
2 
RSV07 
Cohort A 
1 
5x103 
6 
Hypotension 
3 
7 
7 
7 
RSV07 
Cohort A 
1 
5x103 
12 
Tachycardia 
3 
2 
2 
2 
RSV14 
Cohort A 
1 
5x103 
12 
Hypertension 
3 
2 
2 
2 
RSV30 
Cohort B 
1 
5x 104 
5 
Hypertension 
3 
2 
2 
2 
RSv38 
Cohort C 
2 
5x 105 
1 
Hypotension 
3 
0 
0 
0 
RSV42 
Cohort C 
1 
5x 105 
9 
Hypotension 
3 
1 
1 
1 

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13.6. 
Concomitant Medications 
The use of concomitant medications was recorded. The concomitant medications used were 
associated with general adverse events (eg-upper respiratory infections) and general discomfort. 
No subject used any forbidden medications (corticosteroids, other live attenuated vaccines) 
throughout the protocol period. 
13.7. 
Pregnancies (if applicable) 
NA 
13.8. 
Safety Conclusions 
Clinical results indicated that both vaccines, rBCG-N-hRSV and BCG-WT, were safe and 
well tolerated. A higher reactogenicity in terms of abscess and scab formation at the vaccination 
sites was noted with dose escalation of the vaccine study, but none of these reactions were 
unexpected in the context of normal reactogenicity related to licensed intradermal BCG vaccines. 
 
 

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14. 
DISCUSSIONS AND OVERALL CONCLUSION 
The rBCG-N-hRSV vaccine has shown to be safe, well tolerated and immunogenic in 
healthy male adult volunteers. In terms of safety and tolerability, no related SAE were reported 
through the 180 days of follow-up post-vaccination. A higher reactogenicity was observed with 
the dose escalation of the vaccine study in terms of time of appearance and severity of abscess and 
scabbing. Other local events were not increased in association with dose escalations of the study 
vaccine.  
In terms of immunogenicity, rBCG-N-hRSV elicited antigen-specific IgG and cellular 
immune responses against PPD and N-hRSV. Therefore, the rBCG-N-hRSV is a promising 
vaccine to prevent hRSV infection/disease as well as tuberculosis infection/disease in children and 
the elderly. 
 
HRSV may cause severe cases of pneumonia and bronchiolitis in young children and the 
elderly (2). Unfortunately, the only licensed treatment to date for use in preventing severe hRSV 
disease is the monoclonal antibody Palivizumab, mainly indicated for high-risk infants (4). 
However, such treatment is costly and requires repeated doses to be effective (19). Further, 
although high numbers of prototype vaccines against hRSV infection are under development, few 
of them are on clinical trials (10). In the current study, we present the results of a Phase I clinical 
trial of a recombinant BCG that expresses the nucleoprotein of hRSV. BCG is a safe and 
immunogenic vaccine, being a suitable vector for hRSV vaccine (12, 13). Because our vaccine 
was designed using BCG as the vector, as well as to provide Th1 cell-inducing adjuvant properties, 
we evaluated the cellular immune responses of participants against mycobacterial PPD antigens. 
As shown in the cellular immunogenicity assays (Figures 2 to 4), before vaccination all participants 
displayed a modest frequency of cells that secreted IFN-γ and IL-2 in response to PPD stimulation. 
These baseline modest levels of immune response were likely due to the fact that all enrolled 
participants had been vaccinated in childhood with BCG.  Therefore, we expected specific “recall” 
immune responses after in vitro cell stimulation with PPD (20). Once participants were vaccinated 
with the study vaccines (independently of the vaccine used), all demonstrated a sustained increase 
in IFN-γ and IL-2 secretion, starting from 14th day post-vaccination and persisting at least until 
day 30 post-vaccination. We also found that the number of Spot Forming Cells by ELISpot, and 
the frequency by flow cytometry of CD4+ and CD8+ T cells secreting IFN-γ, IL-2 and TNF-α 

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after PPD stimulation, increased as higher doses of the rBCG-N-hRSV vaccine were tested. These 
results indicate that the rBCG-N-hRSV vaccine can induce relevant antigen-specific T cell 
responses protective against TB, and suggest that these TB-specific responses are dose-dependent. 
In contrast to the conventional BCG vaccine, this phase I study was the first time that the 
rBCG-N-hRSV was tested in healthy volunteers, and hRSV-specific immune responses were 
measured to determine the cellular and  humoral immune responses directed against the N-hRSV 
protein. Prior to vaccination, we measured the baseline immune response to N protein and found 
that cells from all participants responded to N protein in vitro by secreting IFN-γ, IL-2 and/or TNF-
α (Figures 3, 4, and Suppl. Figure 1). These baseline N-RSV-specific responses are likely due to 
previous hRSV exposures (3). Similarly, increased anti-F IgG antibody responses were found in 
all subjects enrolled into Cohort A, also suggesting that those subjects had been previously exposed 
to hRSV. It is known that after hRSV infection, cellular and humoral immune responses can be 
increased against hRSV antigens, such as the N protein (21). However, these immune responses 
appear to be ineffective, as recurrent infections can occur (22). We previously described that low 
single doses of BCG-N-hRSV vaccine (3x105 CFUs) were enough to induce Th1 immune 
responses in mice that protected animals against hRSV challenge (15). This antiviral immune 
response was characterized by the secretion of high levels of IFN-γ and IL-17 from T cells after in 
vitro stimulation with hRSV antigens. In accordance with preclinical data, we found that all 
participants given BCG-N-hRSV vaccines increased the numbers of Spot Forming Cells  and the 
frequencies of CD4+ and CD8+ T cells producing IFN-γ after hRSV nucleoprotein antigen in vitro 
stimulation. These levels increased from 14th day post vaccination and remained high at least until 
day 60, and in some cases even until day 180 post-vaccination. As seen with PPD measurements, 
the hRSV-specific immune responses increased with dose escalation. Polyfunctional T cell 
responses (producing combinations of both IFN-γ and IL-2) were more pronounced at day 30 post-
vaccination. 
All available data to date suggest that protective hRSV immune responses must include 
strong CD4+ Th1 responses, and these Th1 responses are not associated with RSV disease 
exacerbation.  This latter point is important since the first FI-hRSV vaccine failed to prevent hRSV 
infection, and even worse vaccinated children had an increased risk of severe disease after hRSV 
infection (7). As described above, we have previously observed in our clinical work that rBCG-N-
hRSV is immunogenic without causing immune enhancement disease in mice (11, 15). Further, in 

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the present phase I clinical study, we did not find any related severe adverse events in response to 
the rBCG-N-hRSV in healthy adult donors. All subjects had a follow-up for 180 days, during 
which they could have been exposed to hRSV infection, and importantly, no severe disease was 
found in any subject.  

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15. 
TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT 
INCLUDED IN THE TEXT 
Table XXV: Listing of local adverse events by subjects.  
*Vaccine type : rBCG-N-hRSV (1), WT-BCG (2).  
**AE type:  local solicited AE (1), local non-solicited AE (2), general solicited AE (3), general AE (4), laboratory registered 
AE (5). 
Subject 
  
Vaccine 
  
AE 
Day post 
AE 
Total AE 
Number 
Cohort 
Type* 
Diagnosis 
type** 
Vaccine 
Start 
Duration 
RSV01 
Cohort A 
2 
Vaccine site sensitivity 
1 
27-06-2017 
27-06-2017 
9 
RSV01 
Cohort A 
2 
Pain vaccination site 
1 
28-06-2017 
28-06-2017 
1 
RSV01 
Cohort A 
2 
Erythema vaccination site 
1 
29-06-2017 
29-06-2017 
1 
RSV01 
Cohort A 
2 
Vaccination site abscess 
1 
18-07-2017 
18-07-2017 
65 
RSV01 
Cohort A 
2 
Vaccination site crust 
1 
18-07-2017 
18-07-2017 
123 
RSV02 
Cohort A 
1 
Vaccine site sensitivity 
1 
28-06-2017 
28-06-2017 
38 
RSV02 
Cohort A 
1 
Erythema vaccination site 
1 
01-07-2017 
01-07-2017 
2 
RSV02 
Cohort A 
1 
Induration vaccination site 
1 
30-06-2017 
30-06-2017 
1 
RSV02 
Cohort A 
1 
Pain vaccination site 
1 
07-07-2017 
07-07-2017 
5 
RSV02 
Cohort A 
1 
Vaccination site abscess 
1 
11-07-2017 
11-07-2017 
2 
RSV02 
Cohort A 
1 
Vaccination site crust 
1 
11-07-2017 
11-07-2017 
67 
RSV03 
Cohort A 
1 
Pruritus vaccination site 
2 
30-06-2017 
30-06-2017 
7 
RSV03 
Cohort A 
1 
Flaking vaccination site 
2 
02-07-2017 
02-07-2017 
25 
RSV03 
Cohort A 
1 
Vaccine site sensitivity 
1 
28-06-2017 
28-06-2017 
74 
RSV03 
Cohort A 
1 
Pain vaccination site 
1 
29-06-2017 
29-06-2017 
3 
RSV03 
Cohort A 
1 
Vaccination site crust 
1 
06-08-2017 
06-08-2017 
40 
RSV03 
Cohort A 
1 
Vaccination site abscess 
1 
27-07-2017 
27-07-2017 
10 
RSV05 
Cohort A 
1 
Erythema vaccination site 
1 
06-07-2017 
06-07-2017 
2 
RSV05 
Cohort A 
1 
Vaccine site sensitivity 
1 
05-07-2017 
05-07-2017 
10 
RSV05 
Cohort A 
1 
Pain vaccination site 
1 
07-07-2017 
07-07-2017 
5 
RSV05 
Cohort A 
1 
Vaccination site abscess 
1 
22-07-2017 
22-07-2017 
3 
RSV05 
Cohort A 
1 
Vaccination site crust 
1 
25-07-2017 
25-07-2017 
33 
RSV07 
Cohort A 
1 
Pain vaccination site 
1 
13-07-2017 
13-07-2017 
10 
RSV07 
Cohort A 
1 
Vaccine site sensitivity 
1 
16-07-2017 
16-07-2017 
11 
RSV07 
Cohort A 
1 
Pruritus vaccination site 
2 
13-07-2017 
13-07-2017 
15 
RSV07 
Cohort A 
1 
Vaccination site abscess 
1 
18-07-2017 
18-07-2017 
7 
RSV07 
Cohort A 
1 
Vaccination site crust 
1 
23-07-2017 
23-07-2017 
74 
RSV10 
Cohort A 
1 
Tiredness in vaccinated arm 
2 
10-07-2017 
10-07-2017 
1 
RSV10 
Cohort A 
1 
Vaccine site sensitivity 
1 
10-07-2017 
10-07-2017 
17 
RSV10 
Cohort A 
1 
Pruritus vaccination site 
2 
12-07-2017 
12-07-2017 
12 
RSV10 
Cohort A 
1 
Erythema vaccination site 
1 
12-07-2017 
12-07-2017 
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RSV10 
Cohort A 
1 
Pain vaccination site 
1 
12-07-2017 
12-07-2017 
15 
RSV10 
Cohort A 
1 
Vaccination site abscess 
1 
20-07-2017 
20-07-2017 
7 
RSV10 
Cohort A 
1 
Vaccination site crust 
1 
20-07-2017 
20-07-2017 
131 
RSV10 
Cohort A 
1 
Induration vaccination site 
1 
11-07-2017 
11-07-2017 
1 
RSV13 
Cohort A 
2 
Pruritus vaccination site 
2 
18-07-2017 
18-07-2017 
6 
RSV13 
Cohort A 
2 
Vaccine site sensitivity 
1 
18-07-2017 
18-07-2017 
2 
RSV13 
Cohort A 
2 
Erythema vaccination site 
1 
18-07-2017 
18-07-2017 
3 
RSV13 
Cohort A 
2 
Vaccination site abscess 
1 
27-07-2017 
27-07-2017 
15 
RSV13 
Cohort A 
2 
Vaccination site crust 
1 
27-07-2017 
27-07-2017 
137 
RSV13 
Cohort A 
2 
Pain vaccination site 
1 
24-07-2017 
24-07-2017 
3 
RSV14 
Cohort A 
1 
Pain vaccination site 
1 
19-07-2017 
19-07-2017 
17 
RSV14 
Cohort A 
1 
Vaccine site sensitivity 
1 
19-07-2017 
19-07-2017 
28 
RSV14 
Cohort A 
1 
Vaccination site abscess 
1 
02-08-2017 
02-08-2017 
1 
RSV14 
Cohort A 
1 
Vaccination site crust 
1 
03-08-2017 
03-08-2017 
11 
RSV14 
Cohort A 
1 
Pruritus vaccination site 
2 
22-07-2017 
22-07-2017 
5 
RSV14 
Cohort A 
1 
Flaking vaccination site 
2 
16-08-2017 
16-08-2017 
8 
RSV16 
Cohort B 
1 
Vaccine site sensitivity 
1 
02-10-2017 
02-10-2017 
11 
RSV16 
Cohort B 
1 
Induration vaccination site 
1 
03-10-2017 
03-10-2017 
20 
RSV16 
Cohort B 
1 
Pruritus vaccination site 
2 
06-10-2017 
06-10-2017 
1 
RSV16 
Cohort B 
1 
Left axillary lymphadenopathy 
1 
06-10-2017 
06-10-2017 
3 
RSV16 
Cohort B 
1 
Vaccination site crust 
1 
14-10-2017 
14-10-2017 
170 
RSV16 
Cohort B 
1 
Vaccination site abscess 
1 
15-10-2017 
15-10-2017 
4 
RSV17 
Cohort B 
1 
Erythema vaccination site 
1 
03-10-2017 
03-10-2017 
4 
RSV17 
Cohort B 
1 
Vaccine site sensitivity 
1 
03-10-2017 
03-10-2017 
13 
RSV17 
Cohort B 
1 
Induration vaccination site 
1 
03-10-2017 
03-10-2017 
4 
RSV17 
Cohort B 
1 
Pain vaccination site 
1 
03-10-2017 
03-10-2017 
13 
RSV17 
Cohort B 
1 
Vaccination site abscess 
1 
12-10-2017 
12-10-2017 
75 
RSV17 
Cohort B 
1 
Vaccination site crust 
1 
13-10-2017 
13-10-2017 
92 
RSV18 
Cohort B 
2 
Vaccine site sensitivity 
1 
04-10-2017 
04-10-2017 
13 
RSV18 
Cohort B 
2 
Erythema vaccination site 
1 
04-10-2017 
04-10-2017 
4 
RSV18 
Cohort B 
2 
Induration vaccination site 
1 
05-10-2017 
05-10-2017 
9 
RSV18 
Cohort B 
2 
Pain vaccination site 
1 
10-10-2017 
10-10-2017 
3 
RSV18 
Cohort B 
2 
Vaccination site abscess 
1 
09-10-2017 
09-10-2017 
7 
RSV18 
Cohort B 
2 
Vaccination site crust 
1 
14-10-2017 
14-10-2017 
142 
RSV24 
Cohort B 
2 
Pain vaccination site 
1 
03-10-2017 
03-10-2017 
12 
RSV24 
Cohort B 
2 
Vaccine site sensitivity 
1 
03-10-2017 
03-10-2017 
15 
RSV24 
Cohort B 
2 
Erythema vaccination site 
1 
04-10-2017 
04-10-2017 
7 
RSV24 
Cohort B 
2 
Induration vaccination site 
1 
04-10-2017 
04-10-2017 
6 
RSV24 
Cohort B 
2 
Vaccination site abscess 
1 
14-10-2017 
14-10-2017 
13 
RSV24 
Cohort B 
2 
Vaccination site crust 
1 
18-10-2017 
18-10-2017 
34 
RSV25 
Cohort B 
1 
Pain vaccination site 
1 
05-10-2017 
05-10-2017 
1 
RSV25 
Cohort B 
1 
Vaccine site sensitivity 
1 
05-10-2017 
05-10-2017 
1 

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RSV25 
Cohort B 
1 
Erythema vaccination site 
1 
06-10-2017 
06-10-2017 
8 
RSV25 
Cohort B 
1 
Vaccination site abscess 
1 
06-10-2017 
06-10-2017 
6 
RSV25 
Cohort B 
1 
Induration vaccination site 
1 
07-10-2017 
07-10-2017 
37 
RSV25 
Cohort B 
1 
Vaccination site crust 
1 
08-10-2017 
08-10-2017 
51 
RSV26 
Cohort B 
1 
Pain vaccination site 
1 
04-10-2017 
04-10-2017 
8 
RSV26 
Cohort B 
1 
Vaccine site sensitivity 
1 
04-10-2017 
04-10-2017 
13 
RSV26 
Cohort B 
1 
Erythema vaccination site 
1 
05-10-2017 
05-10-2017 
16 
RSV26 
Cohort B 
1 
Vaccination site abscess 
1 
11-10-2017 
11-10-2017 
5 
RSV26 
Cohort B 
1 
Ulcer vaccination site 
2 
17-10-2017 
17-10-2017 
2 
RSV26 
Cohort B 
1 
Vaccination site crust 
1 
15-10-2017 
15-10-2017 
91 
RSV27 
Cohort B 
1 
Induration vaccination site 
1 
18-10-2017 
18-10-2017 
11 
RSV27 
Cohort B 
1 
Erythema vaccination site 
1 
05-10-2017 
05-10-2017 
15 
RSV27 
Cohort B 
1 
Pain vaccination site 
1 
04-10-2017 
04-10-2017 
14 
RSV27 
Cohort B 
1 
Vaccine site sensitivity 
1 
04-10-2017 
04-10-2017 
11 
RSV27 
Cohort B 
1 
Pruritus vaccination site 
2 
09-10-2017 
09-10-2017 
2 
RSV27 
Cohort B 
1 
Vaccination site abscess 
1 
12-10-2017 
12-10-2017 
7 
RSV27 
Cohort B 
1 
Vaccination site crust 
1 
18-10-2017 
18-10-2017 
143 
RSV30 
Cohort B 
1 
Vaccine site sensitivity 
1 
10-10-2017 
10-10-2017 
10 
RSV30 
Cohort B 
1 
Pruritus vaccination site 
2 
11-10-2017 
11-10-2017 
7 
RSV30 
Cohort B 
1 
Left axillary pain 
2 
10-10-2017 
10-10-2017 
1 
RSV30 
Cohort B 
1 
Vaccination site crust 
1 
21-10-2017 
21-10-2017 
19 
RSV30 
Cohort B 
1 
Pain vaccination site 
1 
18-10-2017 
18-10-2017 
5 
RSV30 
Cohort B 
1 
Vaccination site abscess 
1 
19-10-2017 
19-10-2017 
3 
RSV32 
Cohort C 
1 
Pain vaccination site 
1 
21-11-2017 
21-11-2017 
15 
RSV32 
Cohort C 
1 
Vaccine site sensitivity 
1 
22-11-2017 
22-11-2017 
18 
RSV32 
Cohort C 
1 
Erythema vaccination site 
1 
22-11-2017 
22-11-2017 
12 
RSV32 
Cohort C 
1 
Vaccination site abscess 
1 
27-11-2017 
27-11-2017 
110 
RSV32 
Cohort C 
1 
Induration vaccination site 
1 
23-11-2017 
23-11-2017 
32 
RSV32 
Cohort C 
1 
Vaccination site crust 
1 
27-11-2017 
27-11-2017 
202 
RSV33 
Cohort C 
1 
Pain vaccination site 
1 
21-11-2017 
21-11-2017 
10 
RSV33 
Cohort C 
1 
Vaccine site sensitivity 
1 
21-11-2017 
21-11-2017 
10 
RSV33 
Cohort C 
1 
Erythema vaccination site 
1 
23-11-2017 
23-11-2017 
4 
RSV33 
Cohort C 
1 
Vaccination site abscess 
1 
26-11-2017 
26-11-2017 
5 
RSV33 
Cohort C 
1 
Vaccination site crust 
1 
28-11-2017 
28-11-2017 
67 
RSV33 
Cohort C 
1 
Induration vaccination site 
1 
28-11-2017 
28-11-2017 
1 
RSV34 
Cohort C 
2 
Pain vaccination site 
1 
21-11-2017 
21-11-2017 
18 
RSV34 
Cohort C 
2 
Vaccine site sensitivity 
1 
22-11-2017 
22-11-2017 
5 
RSV34 
Cohort C 
2 
Erythema vaccination site 
1 
22-11-2017 
22-11-2017 
3 
RSV34 
Cohort C 
2 
Induration vaccination site 
1 
23-11-2017 
23-11-2017 
1 
RSV34 
Cohort C 
2 
Pruritus vaccination site 
2 
24-11-2017 
24-11-2017 
17 
RSV34 
Cohort C 
2 
Vaccination site abscess 
1 
04-12-2017 
04-12-2017 
63 
RSV34 
Cohort C 
2 
Vaccination site crust 
1 
20-02-2018 
20-02-2018 
63 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 47 - 
RSV36 
Cohort C 
1 
Vaccine site sensitivity 
1 
27-11-2017 
27-11-2017 
55 
RSV36 
Cohort C 
1 
Erythema vaccination site 
1 
28-11-2017 
28-11-2017 
8 
RSV36 
Cohort C 
1 
Pain vaccination site 
1 
28-11-2017 
28-11-2017 
11 
RSV36 
Cohort C 
1 
Vaccination site abscess 
1 
01-12-2017 
01-12-2017 
5 
RSV36 
Cohort C 
1 
Vaccination site crust 
1 
04-12-2017 
04-12-2017 
44 
RSV36 
Cohort C 
1 
Ulcer vaccination site 
2 
15-12-2017 
15-12-2017 
14 
RSV38 
Cohort C 
2 
Vaccine site sensitivity 
1 
27-11-2017 
27-11-2017 
38 
RSV38 
Cohort C 
2 
Pain vaccination site 
1 
27-11-2017 
27-11-2017 
21 
RSV38 
Cohort C 
2 
Erythema vaccination site 
1 
28-11-2017 
28-11-2017 
2 
RSV38 
Cohort C 
2 
Pruritus vaccination site 
2 
29-11-2017 
29-11-2017 
7 
RSV38 
Cohort C 
2 
Vaccination site abscess 
1 
05-12-2017 
05-12-2017 
6 
RSV38 
Cohort C 
2 
Vaccination site crust 
1 
08-12-2017 
08-12-2017 
36 
RSV38 
Cohort C 
2 
Ulcer vaccination site 
2 
27-12-2017 
27-12-2017 
10 
RSV40 
Cohort C 
1 
Vaccine site sensitivity 
1 
28-11-2017 
28-11-2017 
19 
RSV40 
Cohort C 
1 
Pain vaccination site 
1 
04-12-2017 
04-12-2017 
11 
RSV40 
Cohort C 
1 
Erythema vaccination site 
1 
04-12-2017 
04-12-2017 
5 
RSV40 
Cohort C 
1 
Induration vaccination site 
1 
06-12-2017 
06-12-2017 
1 
RSV40 
Cohort C 
1 
Vaccination site abscess 
1 
04-12-2017 
04-12-2017 
28 
RSV40 
Cohort C 
1 
Vaccination site crust 
1 
05-12-2017 
05-12-2017 
27 
RSV40 
Cohort C 
1 
Ulcer vaccination site 
2 
01-01-2018 
01-01-2018 
15 
RSV41 
Cohort C 
1 
Vaccine site sensitivity 
1 
28-11-2017 
28-11-2017 
15 
RSV41 
Cohort C 
1 
Pain vaccination site 
1 
29-11-2017 
29-11-2017 
7 
RSV41 
Cohort C 
1 
Vaccination site abscess 
1 
30-11-2017 
30-11-2017 
8 
RSV41 
Cohort C 
1 
Induration vaccination site 
1 
01-12-2017 
01-12-2017 
1 
RSV41 
Cohort C 
1 
Vaccination site crust 
1 
03-12-2017 
03-12-2017 
185 
RSV41 
Cohort C 
1 
Erythema vaccination site 
1 
06-12-2017 
06-12-2017 
1 
RSV42 
Cohort C 
1 
Vaccine site sensitivity 
1 
04-12-2017 
04-12-2017 
14 
RSV42 
Cohort C 
1 
Pain vaccination site 
1 
05-12-2017 
05-12-2017 
6 
RSV42 
Cohort C 
1 
Erythema vaccination site 
1 
05-12-2017 
05-12-2017 
6 
RSV42 
Cohort C 
1 
Vaccination site abscess 
1 
06-12-2017 
06-12-2017 
7 
RSV42 
Cohort C 
1 
left axillary pain 
1 
07-12-2017 
07-12-2017 
7 
RSV42 
Cohort C 
1 
Vaccination site crust 
1 
11-12-2017 
11-12-2017 
103 
 
Table XXVI: Listing of general adverse events by subjects.  
*Vaccine type : rBCG-N-hRSV (1), WT-BCG (2).  
**AE type:  local solicited AE (1), local non-solicited AE (2), general solicited AE (3), general AE (4), laboratory registered 
AE (5). 
Subject 
  
Vaccine 
AE 
  
AE 
Day 
post 
AE 
AE 
N° 
Cohort 
Type* 
N° 
Diagnosis 
Type 
Vaccine 
Start 
End 
RSV01 
Cohort 
A 
2 
1 
Hypophosphate
mia 
5 
8 
05-07-
2017 
13-07-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 48 - 
RSV01 
Cohort 
A 
2 
2 
Hyperglycemia 
5 
8 
05-07-
2017 
13-07-
2017 
RSV01 
Cohort 
A 
2 
3 
Sickness 
3 
13 
10-07-
2017 
10-07-
2017 
RSV01 
Cohort 
A 
2 
4 
Left wrist 
contusion 
4 
9 
06-07-
2017 
22-09-
2017 
RSV01 
Cohort 
A 
2 
5 
Vaccine site 
sensitivity 
1 
0 
27-06-
2017 
29-06-
2017 
RSV01 
Cohort 
A 
2 
6 
Pain vaccination 
site  
1 
1 
28-06-
2017 
28-06-
2017 
RSV01 
Cohort 
A 
2 
7 
Erythema 
vaccination site 
1 
2 
29-06-
2017 
29-06-
2017 
RSV01 
Cohort 
A 
2 
8 
Decreased 
hemoglobin 
5 
8 
05-07-
2017 
Continu
es 
RSV01 
Cohort 
A 
2 
9 
Vaccination site 
abscess 
1 
21 
18-07-
2017 
20-09-
2017 
RSV01 
Cohort 
A 
2 
10 
Proteinuria 
5 
30 
27-07-
2017 
21-08-
2017 
RSV01 
Cohort 
A 
2 
11 
Leukocytosis 
5 
30 
27-07-
2017 
21-08-
2017 
RSV01 
Cohort 
A 
2 
12 
Vaccine site 
sensitivity 
1 
17 
14-07-
2017 
17-07-
2017 
RSV01 
Cohort 
A 
2 
13 
Abdominal pain 
4 
13 
10-07-
2017 
10-07-
2017 
RSV01 
Cohort 
A 
2 
14 
Vaccination site 
crust 
1 
21 
18-07-
2017 
17-11-
2017 
RSV01 
Cohort 
A 
2 
15 
Vaccine site 
sensitivity 
1 
23 
20-07-
2017 
21-07-
2017 
RSV01 
Cohort 
A 
2 
16 
Hematuria 
5 
55 
21-08-
2017 
24-10-
2017 
RSV01 
Cohort 
A 
2 
17 
Proteinuria 
5 
57 
23-08-
2017 
24-10-
2017 
RSV01 
Cohort 
A 
2 
18 
Diarrhea 
3 
12 
09-07-
2017 
09-07-
2017 
RSV01 
Cohort 
A 
2 
19 
Headache 
3 
12 
09-07-
2017 
09-07-
2017 
RSV01 
Cohort 
A 
2 
20 
Hypernatremia 
5 
119 
24-10-
2017 
26-10-
2017 
RSV02 
Cohort 
A 
1 
1 
Leukopenia 
5 
6 
04-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
2 
Neutropenia 
5 
6 
04-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
3 
Increase in CPK 
5 
6 
04-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
4 
Vaccine site 
sensitivity 
1 
0 
28-06-
2017 
04-08-
2017 
RSV02 
Cohort 
A 
1 
5 
Erythema 
vaccination site 
1 
3 
01-07-
2017 
01-07-
2017 
RSV02 
Cohort 
A 
1 
6 
Induration 
vaccination site 
1 
2 
30-06-
2017 
30-06-
2017 
RSV02 
Cohort 
A 
1 
7 
Pain vaccination 
site  
1 
9 
07-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
8 
Decrease 
hemoglobin 
5 
13 
11-07-
2017 
24-07-
2017 
RSV02 
Cohort 
A 
1 
9 
Vaccination site 
abscess 
1 
13 
11-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
10 
Diarrhea 
3 
13 
11-07-
2017 
11-07-
2017 
RSV02 
Cohort 
A 
1 
11 
Diarrhea 
3 
15 
13-07-
2017 
13-07-
2017 
RSV02 
Cohort 
A 
1 
12 
Erythema 
vaccination site 
1 
6 
04-07-
2017 
04-07-
2017 
RSV02 
Cohort 
A 
1 
13 
Leukopenia 
5 
26 
24-07-
2017 
Continu
es 
RSV02 
Cohort 
A 
1 
14 
Vaccination site 
crust 
1 
13 
11-07-
2017 
15-09-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 49 - 
RSV02 
Cohort 
A 
1 
15 
Lymphopenia 
5 
55 
22-08-
2017 
25-10-
2017 
RSV02 
Cohort 
A 
1 
16 
Diarrhea 
3 
11 
09-07-
2017 
09-07-
2017 
RSV02 
Cohort 
A 
1 
17 
Vaccination site 
crust 
1 
17 
15-07-
2017 
15-07-
2017 
RSV02 
Cohort 
A 
1 
18 
Increase in CPK 
5 
119 
25-10-
2017 
18-12-
2017 
RSV02 
Cohort 
A 
1 
19 
Hyperglycemia 
5 
173 
18-12-
2017 
26-12-
2017 
RSV02 
Cohort 
A 
1 
20 
Decreased 
hemoglobin 
5 
173 
18-12-
2017 
Continu
es 
RSV03 
Cohort 
A 
1 
1 
Pruritus 
vaccination site 
2 
3 
30-06-
2017 
06-07-
2017 
RSV03 
Cohort 
A 
1 
2 
Flaking 
vaccination site 
2 
5 
02-07-
2017 
26-07-
2017 
RSV03 
Cohort 
A 
1 
3 
Common cold 
4 
11 
08-07-
2017 
24-07-
2017 
RSV03 
Cohort 
A 
1 
4 
Increase in CPK 
5 
7 
04-07-
2017 
10-07-
2017 
RSV03 
Cohort 
A 
1 
5 
Hypoproteinemi
a 
5 
7 
04-07-
2017 
10-07-
2017 
RSV03 
Cohort 
A 
1 
6 
Vaccine site 
sensitivity 
1 
1 
28-06-
2017 
03-07-
2017 
RSV03 
Cohort 
A 
1 
7 
Pain vaccination 
site  
1 
2 
29-06-
2017 
30-06-
2017 
RSV03 
Cohort 
A 
1 
8 
Decrease 
hemoglobin 
5 
7 
04-07-
2017 
10-07-
2017 
RSV03 
Cohort 
A 
1 
9 
Fatigue 
3 
22 
19-07-
2017 
19-07-
2017 
RSV03 
Cohort 
A 
1 
10 
Fatigue 
3 
24 
21-07-
2017 
23-07-
2017 
RSV03 
Cohort 
A 
1 
11 
Headache 
3 
21 
18-07-
2017 
19-07-
2017 
RSV03 
Cohort 
A 
1 
12 
Headache 
3 
24 
21-07-
2017 
23-07-
2017 
RSV03 
Cohort 
A 
1 
13 
Myalgia 
3 
25 
22-07-
2017 
23-07-
2017 
RSV03 
Cohort 
A 
1 
14 
Vaccine site 
sensitivity 
1 
10 
07-07-
2017 
09-07-
2017 
RSV03 
Cohort 
A 
1 
15 
Vaccine site 
sensitivity 
1 
14 
11-07-
2017 
16-07-
2017 
RSV03 
Cohort 
A 
1 
16 
Vaccine site 
sensitivity 
1 
21 
18-07-
2017 
14-09-
2017 
RSV03 
Cohort 
A 
1 
17 
Decrease 
hemoglobin 
5 
34 
31-07-
2017 
31-08-
2017 
RSV03 
Cohort 
A 
1 
18 
Leukopenia 
5 
34 
31-07-
2017 
27-12-
2017 
RSV03 
Cohort 
A 
1 
19 
Vaccination site 
crust 
1 
40 
06-08-
2017 
14-09-
2017 
RSV03 
Cohort 
A 
1 
20 
Vaccination site 
abscess 
1 
30 
27-07-
2017 
05-08-
2017 
RSV03 
Cohort 
A 
1 
21 
Pain vaccination 
site  
1 
25 
22-07-
2017 
22-07-
2017 
RSV03 
Cohort 
A 
1 
22 
Tachycardia 
3 
1 
28-06-
2017 
28-06-
2017 
RSV03 
Cohort 
A 
1 
23 
Headache 
4 
148 
22-11-
2017 
22-11-
2017 
RSV05 
Cohort 
A 
1 
1 
Puncture site 
ecchymosis 
4 
1 
05-07-
2017 
10-07-
2017 
RSV05 
Cohort 
A 
1 
2 
Hypertension 
3 
2 
06-07-
2017 
06-07-
2017 
RSV05 
Cohort 
A 
1 
3 
Erythema 
vaccination site 
1 
2 
06-07-
2017 
07-07-
2017 
RSV05 
Cohort 
A 
1 
4 
Vaccine site 
sensitivity 
1 
1 
05-07-
2017 
08-07-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 50 - 
RSV05 
Cohort 
A 
1 
5 
Pain vaccination 
site  
1 
3 
07-07-
2017 
07-07-
2017 
RSV05 
Cohort 
A 
1 
6 
Decreased 
hemoglobin 
5 
8 
12-07-
2017 
19-07-
2017 
RSV05 
Cohort 
A 
1 
7 
Headache 
3 
8 
12-07-
2017 
13-07-
2017 
RSV05 
Cohort 
A 
1 
8 
Bilateral Otalgia 
4 
8 
12-07-
2017 
14-07-
2017 
RSV05 
Cohort 
A 
1 
9 
Retro ocular left 
pain 
4 
8 
12-07-
2017 
13-07-
2017 
RSV05 
Cohort 
A 
1 
10 
Fatigue 
3 
8 
12-07-
2017 
12-07-
2017 
RSV05 
Cohort 
A 
1 
11 
Increase in CPK 
5 
15 
19-07-
2017 
07-08-
2017 
RSV05 
Cohort 
A 
1 
12 
Tonsillitis 
4 
14 
18-07-
2017 
02-08-
2017 
RSV05 
Cohort 
A 
1 
13 
Pain vaccination 
site  
1 
16 
20-07-
2017 
23-07-
2017 
RSV05 
Cohort 
A 
1 
14 
Vaccine site 
sensitivity 
1 
16 
20-07-
2017 
25-07-
2017 
RSV05 
Cohort 
A 
1 
15 
Vaccination site 
abscess 
1 
18 
22-07-
2017 
24-07-
2017 
RSV05 
Cohort 
A 
1 
16 
Headache 
3 
18 
22-07-
2017 
23-07-
2017 
RSV05 
Cohort 
A 
1 
17 
Headache 
3 
23 
27-07-
2017 
28-07-
2017 
RSV05 
Cohort 
A 
1 
18 
Fatigue 
3 
18 
22-07-
2017 
23-07-
2017 
RSV05 
Cohort 
A 
1 
19 
Fatigue 
3 
23 
27-07-
2017 
28-07-
2017 
RSV05 
Cohort 
A 
1 
20 
Vaccination site 
crust 
1 
21 
25-07-
2017 
26-08-
2017 
RSV05 
Cohort 
A 
1 
21 
Sickness 
3 
8 
12-07-
2017 
12-07-
2017 
RSV05 
Cohort 
A 
1 
22 
Common cold 
4 
65 
07-09-
2017 
10-09-
2017 
RSV05 
Cohort 
A 
1 
23 
Decrease 
haemoglobin 
5 
113 
25-10-
2017 
Continu
es 
RSV05 
Cohort 
A 
1 
24 
Increase in CPK 
5 
113 
25-10-
2017 
29-12-
2017 
RSV05 
Cohort 
A 
1 
25 
Acute 
gastroenteritis 
4 
174 
25-12-
2017 
01-01-
2018 
RSV07 
Cohort 
A 
1 
1 
Common cold 
4 
0 
10-07-
2017 
12-07-
2017 
RSV07 
Cohort 
A 
1 
2 
Headache 
3 
0 
10-07-
2017 
10-07-
2017 
RSV07 
Cohort 
A 
1 
3 
Pain vaccination 
site  
1 
3 
13-07-
2017 
14-07-
2017 
RSV07 
Cohort 
A 
1 
4 
Headache 
3 
3 
13-07-
2017 
13-07-
2017 
RSV07 
Cohort 
A 
1 
5 
Vaccine site 
sensitivity 
1 
6 
16-07-
2017 
26-07-
2017 
RSV07 
Cohort 
A 
1 
6 
Hypotension 
3 
7 
17-07-
2017 
17-07-
2017 
RSV07 
Cohort 
A 
1 
7 
Proteinuria 
5 
7 
17-07-
2017 
26-07-
2017 
RSV07 
Cohort 
A 
1 
8 
Increase in CPK 
5 
7 
17-07-
2017 
26-07-
2017 
RSV07 
Cohort 
A 
1 
10 
Pruritus 
vaccination site 
2 
3 
13-07-
2017 
26-07-
2017 
RSV07 
Cohort 
A 
1 
11 
Hypercholestero
lemia 
5 
16 
26-07-
2017 
10-08-
2017 
RSV07 
Cohort 
A 
1 
12 
Tachycardia 
3 
2 
12-07-
2017 
12-07-
2017 
RSV07 
Cohort 
A 
1 
9 
Cough 
4 
6 
16-07-
2017 
22-07-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 51 - 
RSV07 
Cohort 
A 
1 
13 
Pain vaccination 
site  
1 
6 
16-07-
2017 
22-07-
2017 
RSV07 
Cohort 
A 
1 
14 
Fatigue 
3 
8 
18-07-
2017 
18-07-
2017 
RSV07 
Cohort 
A 
1 
15 
Vaccination site 
abscess 
1 
8 
18-07-
2017 
22-07-
2017 
RSV07 
Cohort 
A 
1 
16 
Vaccination site 
crust 
1 
13 
23-07-
2017 
04-10-
2017 
RSV07 
Cohort 
A 
1 
17 
Decreased 
haemoglobin 
5 
31 
10-08-
2017 
08-09-
2017 
RSV07 
Cohort 
A 
1 
18 
Vaccination site 
abscess 
1 
40 
19-08-
2017 
19-08-
2017 
RSV07 
Cohort 
A 
1 
19 
Pain vaccination 
site  
1 
40 
19-08-
2017 
19-08-
2017 
RSV07 
Cohort 
A 
1 
20 
Wisdom tooth 
pain 
4 
38 
17-08-
2017 
18-08-
2017 
RSV07 
Cohort 
A 
1 
21 
Pruritus 
vaccination site 
2 
3 
13-07-
2017 
13-07-
2017 
RSV07 
Cohort 
A 
1 
22 
Wisdom tooth 
pain 
4 
42 
21-08-
2017 
23-08-
2017 
RSV07 
Cohort 
A 
1 
23 
Wisdom tooth 
pain 
4 
54 
02-09-
2017 
06-09-
2017 
RSV07 
Cohort 
A 
1 
24 
Scratch in crust 
area 
4 
48 
27-08-
2017 
27-08-
2017 
RSV07 
Cohort 
A 
1 
25 
Vaccination site 
crust 
1 
48 
27-08-
2017 
27-08-
2017 
RSV07 
Cohort 
A 
1 
26 
Hypercholestero
lemia 
5 
60 
08-09-
2017 
08-01-
2018 
RSV07 
Cohort 
A 
1 
27 
Headache 
3 
9 
19-07-
2017 
20-07-
2017 
RSV07 
Cohort 
A 
1 
28 
Decreased 
hemoglobin 
5 
120 
07-11-
2017 
Continu
es 
RSV07 
Cohort 
A 
1 
29 
Pyuria 
5 
120 
07-11-
2017 
08-01-
2018 
RSV07 
Cohort 
A 
1 
30 
Increased TTPA 
5 
120 
07-11-
2017 
08-01-
2018 
RSV10 
Cohort 
A 
1 
1 
Tiredness in 
vaccinated arm 
(left) 
2 
0 
10-07-
2017 
10-07-
2017 
RSV10 
Cohort 
A 
1 
2 
Vaccine site 
sensitivity 
1 
0 
10-07-
2017 
10-07-
2017 
RSV10 
Cohort 
A 
1 
3 
Pruritus 
vaccination site 
2 
2 
12-07-
2017 
23-07-
2017 
RSV10 
Cohort 
A 
1 
4 
Vaccine site 
sensitivity 
1 
1 
11-07-
2017 
27-07-
2017 
RSV10 
Cohort 
A 
1 
5 
Erythema 
vaccination site 
1 
2 
12-07-
2017 
13-07-
2017 
RSV10 
Cohort 
A 
1 
6 
Pain vaccination 
site  
1 
2 
12-07-
2017 
15-07-
2017 
RSV10 
Cohort 
A 
1 
7 
Sickness 
3 
0 
10-07-
2017 
10-07-
2017 
RSV10 
Cohort 
A 
1 
8 
Vaccination site 
abscess 
1 
10 
20-07-
2017 
24-07-
2017 
RSV10 
Cohort 
A 
1 
9 
Decreased 
haemoglobin 
5 
14 
24-07-
2017 
07-08-
2017 
RSV10 
Cohort 
A 
1 
10 
Increase in CPK 
5 
14 
24-07-
2017 
07-08-
2017 
RSV10 
Cohort 
A 
1 
11 
Vaccination site 
crust 
1 
10 
20-07-
2017 
27-11-
2017 
RSV10 
Cohort 
A 
1 
12 
Pain vaccination 
site  
1 
7 
17-07-
2017 
27-07-
2017 
RSV10 
Cohort 
A 
1 
13 
Induration 
vaccination site 
1 
1 
11-07-
2017 
11-07-
2017 
RSV10 
Cohort 
A 
1 
14 
Acute 
rhinopharyngou
sitis 
4 
36 
15-08-
2017 
25-08-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 52 - 
RSV10 
Cohort 
A 
1 
15 
Fever 
4 
36 
15-08-
2017 
16-08-
2017 
RSV10 
Cohort 
A 
1 
16 
Vaccination site 
abscess 
1 
73 
21-09-
2017 
22-09-
2017 
RSV10 
Cohort 
A 
1 
17 
Acute 
pharyngitis 
4 
117 
04-11-
2017 
23-11-
2017 
RSV10 
Cohort 
A 
1 
18 
Hypoglycemia 
5 
120 
07-11-
2017 
06-01-
2018 
RSV10 
Cohort 
A 
1 
19 
Leukocytosis 
5 
120 
07-11-
2017 
06-01-
2018 
RSV10 
Cohort 
A 
1 
20 
Decreased 
hemoglobin 
5 
180 
06-01-
2018 
Continu
es 
RSV13 
Cohort 
A 
2 
1 
Pruritus 
vaccination site 
2 
1 
18-07-
2017 
23-07-
2017 
RSV13 
Cohort 
A 
2 
2 
Vaccine site 
sensitivity 
1 
1 
18-07-
2017 
19-07-
2017 
RSV13 
Cohort 
A 
2 
3 
Erythema 
vaccination site 
1 
1 
18-07-
2017 
20-07-
2017 
RSV13 
Cohort 
A 
2 
4 
Leukopenia 
5 
7 
24-07-
2017 
08-09-
2017 
RSV13 
Cohort 
A 
2 
5 
Vaccination site 
abscess 
1 
10 
27-07-
2017 
10-08-
2017 
RSV13 
Cohort 
A 
2 
6 
Headache 
3 
8 
25-07-
2017 
25-07-
2017 
RSV13 
Cohort 
A 
2 
7 
Vaccination site 
crust 
1 
10 
27-07-
2017 
07-09-
2017 
RSV13 
Cohort 
A 
2 
8 
Headache 
3 
13 
30-07-
2017 
30-07-
2017 
RSV13 
Cohort 
A 
2 
9 
Odynophagia 
4 
24 
10-08-
2017 
10-08-
2017 
RSV13 
Cohort 
A 
2 
10 
Pain vaccination 
site  
1 
7 
24-07-
2017 
26-07-
2017 
RSV13 
Cohort 
A 
2 
11 
Headache 
4 
38 
24-08-
2017 
24-08-
2017 
RSV13 
Cohort 
A 
2 
12 
Headache 
4 
40 
26-08-
2017 
26-08-
2017 
RSV13 
Cohort 
A 
2 
13 
Common cold 
4 
45 
31-08-
2017 
15-09-
2017 
RSV13 
Cohort 
A 
2 
14 
Epistaxis 
4 
49 
04-09-
2017 
11-09-
2017 
RSV13 
Cohort 
A 
2 
15 
Vaccination site 
crust 
1 
55 
10-09-
2017 
20-09-
2017 
RSV13 
Cohort 
A 
2 
16 
Vaccination site 
crust 
1 
68 
23-09-
2017 
18-11-
2017 
RSV13 
Cohort 
A 
2 
17 
Leg pain 
4 
58 
13-09-
2017 
15-09-
2017 
RSV13 
Cohort 
A 
2 
18 
Headache 
4 
75 
30-09-
2017 
30-09-
2017 
RSV13 
Cohort 
A 
2 
19 
Headache 
4 
81 
06-10-
2017 
06-10-
2017 
RSV13 
Cohort 
A 
2 
20 
Headache 
4 
116 
10-11-
2017 
10-11-
2017 
RSV13 
Cohort 
A 
2 
21 
Leukopenia 
5 
120 
14-11-
2017 
Continu
es 
RSV13 
Cohort 
A 
2 
22 
Vaccination site 
crust 
1 
124 
18-11-
2017 
26-11-
2017 
RSV13 
Cohort 
A 
2 
23 
Vaccination site 
crust 
1 
132 
26-11-
2017 
12-12-
2017 
RSV13 
Cohort 
A 
2 
24 
Headache 
4 
130 
24-11-
2017 
24-11-
2017 
RSV13 
Cohort 
A 
2 
25 
Headache 
4 
137 
01-12-
2017 
01-12-
2017 
RSV13 
Cohort 
A 
2 
26 
Headache 
4 
143 
07-12-
2017 
07-12-
2017 
RSV13 
Cohort 
A 
2 
27 
Headache 
4 
166 
30-12-
2017 
30-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 53 - 
RSV13 
Cohort 
A 
2 
28 
Hypophosphate
mia 
5 
175 
08-01-
2018 
Continu
es 
RSV14 
Cohort 
A 
1 
1 
Pain vaccination 
site  
1 
1 
19-07-
2017 
04-08-
2017 
RSV14 
Cohort 
A 
1 
2 
Vaccine site 
sensitivity 
1 
1 
19-07-
2017 
04-08-
2017 
RSV14 
Cohort 
A 
1 
4 
Increase in CPK 
5 
8 
26-07-
2017 
02-08-
2017 
RSV14 
Cohort 
A 
1 
5 
Increase in 
SGOT 
5 
8 
26-07-
2017 
02-08-
2017 
RSV14 
Cohort 
A 
1 
6 
Leukopenia 
5 
8 
26-07-
2017 
02-08-
2017 
RSV14 
Cohort 
A 
1 
7 
Hypercholestero
lemia 
5 
15 
02-08-
2017 
16-08-
2017 
RSV14 
Cohort 
A 
1 
8 
Bronchitis 
4 
16 
03-08-
2017 
12-08-
2017 
RSV14 
Cohort 
A 
1 
9 
Vaccination site 
abscess 
1 
15 
02-08-
2017 
02-08-
2017 
RSV14 
Cohort 
A 
1 
10 
Vaccination site 
crust 
1 
16 
03-08-
2017 
13-08-
2017 
RSV14 
Cohort 
A 
1 
3 
Pruritus 
vaccination site 
2 
4 
22-07-
2017 
26-07-
2017 
RSV14 
Cohort 
A 
1 
11 
Increase TTPA 
5 
29 
16-08-
2017 
13-09-
2017 
RSV14 
Cohort 
A 
1 
12 
Hypertension 
3 
2 
20-07-
2017 
20-07-
2017 
RSV14 
Cohort 
A 
1 
13 
Vaccine site 
sensitivity 
1 
4 
22-07-
2017 
01-08-
2017 
RSV14 
Cohort 
A 
1 
14 
Common cold 
4 
38 
25-08-
2017 
01-09-
2017 
RSV14 
Cohort 
A 
1 
15 
Bronchitis 
4 
46 
02-09-
2017 
15-09-
2017 
RSV14 
Cohort 
A 
1 
16 
Flaking 
vaccination site 
2 
29 
16-08-
2017 
23-08-
2017 
RSV14 
Cohort 
A 
1 
17 
Leukopenia 
5 
57 
13-09-
2017 
14-11-
2017 
RSV14 
Cohort 
A 
1 
18 
Neutropenia 
5 
57 
13-09-
2017 
14-11-
2017 
RSV14 
Cohort 
A 
1 
19 
Leukopenia 
5 
181 
15-01-
2018 
Continu
es 
RSV14 
Cohort 
A 
1 
20 
Neutropenia 
5 
181 
15-01-
2018 
Continu
es 
RSV16 
Cohort 
B 
1 
1 
Vaccine site 
sensitivity 
1 
0 
02-10-
2017 
05-10-
2017 
RSV16 
Cohort 
B 
1 
2 
Induration 
vaccination site 
1 
1 
03-10-
2017 
22-10-
2017 
RSV16 
Cohort 
B 
1 
3 
Pruritus 
vaccination site 
2 
4 
06-10-
2017 
06-10-
2017 
RSV16 
Cohort 
B 
1 
4 
Left axillary 
lymphadenopath
y 
1 
4 
06-10-
2017 
06-10-
2017 
RSV16 
Cohort 
B 
1 
5 
Left axillary 
lymphadenopath
y 
1 
7 
09-10-
2017 
09-10-
2017 
RSV16 
Cohort 
B 
1 
6 
Decreased 
haemoglobin 
5 
8 
10-10-
2017 
Continu
es 
RSV16 
Cohort 
B 
1 
7 
Vaccine site 
sensitivity 
1 
12 
14-10-
2017 
20-10-
2017 
RSV16 
Cohort 
B 
1 
8 
Vaccination site 
crust 
1 
12 
14-10-
2017 
01-04-
2018 
RSV16 
Cohort 
B 
1 
9 
Vaccination site 
abscess 
1 
13 
15-10-
2017 
15-10-
2017 
RSV16 
Cohort 
B 
1 
10 
Vaccination site 
abscess 
1 
16 
18-10-
2017 
18-10-
2017 
RSV16 
Cohort 
B 
1 
11 
Vaccination site 
abscess 
1 
18 
20-10-
2017 
20-10-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 54 - 
RSV16 
Cohort 
B 
1 
12 
Vaccination site 
abscess 
1 
24 
26-10-
2017 
26-10-
2017 
RSV16 
Cohort 
B 
1 
13 
Increase in 
SGPT 
5 
29 
31-10-
2017 
11-12-
2017 
RSV16 
Cohort 
B 
1 
14 
Left axillary 
lymphadenopath
y 
1 
25 
27-10-
2017 
27-10-
2017 
RSV16 
Cohort 
B 
1 
15 
Common cold 
4 
108 
18-01-
2018 
20-01-
2018 
RSV16 
Cohort 
B 
1 
16 
Increase in 
SGPT 
5 
182 
02-04-
2018 
Continu
es 
RSV17 
Cohort 
B 
1 
1 
Erythema 
vaccination site 
1 
1 
03-10-
2017 
04-10-
2017 
RSV17 
Cohort 
B 
1 
2 
Vaccine site 
sensitivity 
1 
1 
03-10-
2017 
15-10-
2017 
RSV17 
Cohort 
B 
1 
3 
Induration 
vaccination site 
1 
1 
03-10-
2017 
06-10-
2017 
RSV17 
Cohort 
B 
1 
4 
Pain vaccination 
site  
1 
1 
03-10-
2017 
15-10-
2017 
RSV17 
Cohort 
B 
1 
5 
Fatigue 
3 
1 
03-10-
2017 
03-10-
2017 
RSV17 
Cohort 
B 
1 
6 
Erythema 
vaccination site 
1 
5 
07-10-
2017 
08-10-
2017 
RSV17 
Cohort 
B 
1 
7 
Decrease 
haemoglobin 
5 
8 
10-10-
2017 
16-10-
2017 
RSV17 
Cohort 
B 
1 
8 
Increase in CPK 
5 
8 
10-10-
2017 
16-10-
2017 
RSV17 
Cohort 
B 
1 
9 
Vaccination site 
abscess 
1 
10 
12-10-
2017 
13-10-
2017 
RSV17 
Cohort 
B 
1 
10 
Vaccination site 
crust 
1 
11 
13-10-
2017 
20-10-
2017 
RSV17 
Cohort 
B 
1 
11 
Vaccination site 
abscess 
1 
14 
16-10-
2017 
29-10-
2017 
RSV17 
Cohort 
B 
1 
12 
Decrease 
haemoglobin 
5 
28 
30-10-
2017 
04-12-
2017 
RSV17 
Cohort 
B 
1 
13 
Leukopenia 
5 
28 
30-10-
2017 
04-12-
2017 
RSV17 
Cohort 
B 
1 
14 
Increase in CPK 
5 
28 
30-10-
2017 
04-12-
2017 
RSV17 
Cohort 
B 
1 
15 
Vaccination site 
crust 
1 
49 
20-11-
2017 
11-02-
2018 
RSV17 
Cohort 
B 
1 
16 
Vaccination site 
abscess 
1 
70 
11-12-
2017 
07-02-
2018 
RSV17 
Cohort 
B 
1 
17 
Decreased 
haemoglobin 
5 
121 
31-01-
2018 
Continu
es 
RSV18 
Cohort 
B 
2 
1 
Vaccine site 
sensitivity 
1 
1 
04-10-
2017 
11-10-
2017 
RSV18 
Cohort 
B 
2 
2 
Erythema 
vaccination site 
1 
1 
04-10-
2017 
07-10-
2017 
RSV18 
Cohort 
B 
2 
3 
Induration 
vaccination site 
1 
2 
05-10-
2017 
13-10-
2017 
RSV18 
Cohort 
B 
2 
4 
Pain vaccination 
site  
1 
7 
10-10-
2017 
11-10-
2017 
RSV18 
Cohort 
B 
2 
5 
Vaccination site 
abscess 
1 
6 
09-10-
2017 
15-10-
2017 
RSV18 
Cohort 
B 
2 
6 
Diarrhea 
3 
7 
10-10-
2017 
11-10-
2017 
RSV18 
Cohort 
B 
2 
7 
Hypercholestero
lemia 
5 
9 
12-10-
2017 
Continu
es 
RSV18 
Cohort 
B 
2 
8 
Diarrhea 
3 
10 
13-10-
2017 
13-10-
2017 
RSV18 
Cohort 
B 
2 
9 
Diarrhea 
3 
13 
16-10-
2017 
16-10-
2017 
RSV18 
Cohort 
B 
2 
10 
Vaccination site 
crust 
1 
11 
14-10-
2017 
31-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 55 - 
RSV18 
Cohort 
B 
2 
11 
Pain vaccination 
site  
1 
10 
13-10-
2017 
13-10-
2017 
RSV18 
Cohort 
B 
2 
12 
Vaccine site 
sensitivity 
1 
10 
13-10-
2017 
19-10-
2017 
RSV18 
Cohort 
B 
2 
13 
Diarrhea 
3 
25 
28-10-
2017 
28-10-
2017 
RSV18 
Cohort 
B 
2 
14 
Diarrhea 
3 
28 
31-10-
2017 
31-10-
2017 
RSV18 
Cohort 
B 
2 
15 
Left thigh 
cellulitis 
4 
28 
31-10-
2017 
15-11-
2017 
RSV18 
Cohort 
B 
2 
16 
Hyperglycemia 
5 
63 
05-12-
2017 
18-01-
2018 
RSV18 
Cohort 
B 
2 
17 
Headache 
4 
90 
01-01-
2018 
01-01-
2018 
RSV18 
Cohort 
B 
2 
18 
Decreased 
haemoglobin 
5 
107 
18-01-
2018 
26-03-
2018 
RSV18 
Cohort 
B 
2 
19 
Increase in CPK 
5 
107 
18-01-
2018 
Continu
es 
RSV18 
Cohort 
B 
2 
20 
Vaccination site 
crust 
1 
107 
18-01-
2018 
21-03-
2018 
RSV18 
Cohort 
B 
2 
21 
Headache 
4 
148 
28-02-
2018 
28-02-
2018 
RSV24 
Cohort 
B 
2 
1 
Pain vaccination 
site  
1 
0 
03-10-
2017 
06-10-
2017 
RSV24 
Cohort 
B 
2 
2 
Vaccine site 
sensitivity 
1 
0 
03-10-
2017 
06-10-
2017 
RSV24 
Cohort 
B 
2 
3 
Headache 
3 
0 
03-10-
2017 
03-10-
2017 
RSV24 
Cohort 
B 
2 
4 
Erythema 
vaccination site 
1 
1 
04-10-
2017 
10-10-
2017 
RSV24 
Cohort 
B 
2 
5 
Induration 
vaccination site 
1 
1 
04-10-
2017 
08-10-
2017 
RSV24 
Cohort 
B 
2 
6 
Pain vaccination 
site  
1 
5 
08-10-
2017 
08-10-
2017 
RSV24 
Cohort 
B 
2 
7 
Vaccine site 
sensitivity 
1 
5 
08-10-
2017 
18-10-
2017 
RSV24 
Cohort 
B 
2 
8 
Headache 
3 
10 
13-10-
2017 
13-10-
2017 
RSV24 
Cohort 
B 
2 
9 
Vaccination site 
abscess 
1 
11 
14-10-
2017 
23-10-
2017 
RSV24 
Cohort 
B 
2 
10 
Pain vaccination 
site  
1 
8 
11-10-
2017 
17-10-
2017 
RSV24 
Cohort 
B 
2 
11 
Induration 
vaccination site 
1 
10 
13-10-
2017 
13-10-
2017 
RSV24 
Cohort 
B 
2 
12 
Headache 
3 
19 
22-10-
2017 
22-10-
2017 
RSV24 
Cohort 
B 
2 
13 
Headache 
3 
21 
24-10-
2017 
24-10-
2017 
RSV24 
Cohort 
B 
2 
14 
Vaccination site 
crust 
1 
15 
18-10-
2017 
20-11-
2017 
RSV24 
Cohort 
B 
2 
15 
Common cold 
4 
26 
29-10-
2017 
31-10-
2017 
RSV24 
Cohort 
B 
2 
16 
Vaccination site 
abscess 
1 
22 
25-10-
2017 
26-10-
2017 
RSV24 
Cohort 
B 
2 
17 
Vaccination site 
abscess 
1 
26 
29-10-
2017 
29-10-
2017 
RSV24 
Cohort 
B 
2 
18 
Proteinuria 
5 
28 
31-10-
2017 
29-11-
2017 
RSV24 
Cohort 
B 
2 
19 
Muscle 
contracture back 
4 
107 
18-01-
2018 
23-01-
2018 
RSV25 
Cohort 
B 
1 
1 
Pain vaccination 
site  
1 
1 
05-10-
2017 
05-10-
2017 
RSV25 
Cohort 
B 
1 
2 
Vaccine site 
sensitivity 
1 
1 
05-10-
2017 
05-10-
2017 
RSV25 
Cohort 
B 
1 
3 
Erythema 
vaccination site 
1 
2 
06-10-
2017 
12-10-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 56 - 
RSV25 
Cohort 
B 
1 
4 
Vaccination site 
abscess 
1 
2 
06-10-
2017 
11-10-
2017 
RSV25 
Cohort 
B 
1 
5 
Induration 
vaccination site 
1 
3 
07-10-
2017 
11-10-
2017 
RSV25 
Cohort 
B 
1 
6 
Vaccination site 
crust 
1 
4 
08-10-
2017 
27-11-
2017 
RSV25 
Cohort 
B 
1 
7 
Decreased 
haemoglobin 
5 
7 
11-10-
2017 
04-12-
2017 
RSV25 
Cohort 
B 
1 
8 
Hypophosphate
mia 
5 
7 
11-10-
2017 
31-10-
2017 
RSV25 
Cohort 
B 
1 
9 
Erythema 
vaccination site 
1 
14 
18-10-
2017 
18-10-
2017 
RSV25 
Cohort 
B 
1 
10 
Induration 
vaccination site 
1 
14 
18-10-
2017 
18-11-
2017 
RSV25 
Cohort 
B 
1 
11 
Hypophosphate
mia 
5 
61 
04-12-
2017 
02-04-
2018 
RSV25 
Cohort 
B 
1 
12 
Decreased 
haemoglobin 
5 
110 
22-01-
2018 
Continu
es 
RSV25 
Cohort 
B 
1 
13 
Increase in 
SGPT 
5 
110 
22-01-
2018 
02-04-
2018 
RSV26 
Cohort 
B 
1 
1 
Pain vaccination 
site  
1 
0 
04-10-
2017 
07-10-
2017 
RSV26 
Cohort 
B 
1 
2 
Vaccine site 
sensitivity 
1 
0 
04-10-
2017 
08-10-
2017 
RSV26 
Cohort 
B 
1 
3 
Erythema 
vaccination site 
1 
1 
05-10-
2017 
20-10-
2017 
RSV26 
Cohort 
B 
1 
4 
Vaccine site 
sensitivity 
1 
6 
10-10-
2017 
17-10-
2017 
RSV26 
Cohort 
B 
1 
5 
Vaccination site 
abscess 
1 
7 
11-10-
2017 
15-10-
2017 
RSV26 
Cohort 
B 
1 
6 
Decreased 
haemoglobin 
5 
7 
11-10-
2017 
18-10-
2017 
RSV26 
Cohort 
B 
1 
7 
Fatigue 
3 
0 
04-10-
2017 
04-10-
2017 
RSV26 
Cohort 
B 
1 
8 
Pain vaccination 
site  
1 
7 
11-10-
2017 
13-10-
2017 
RSV26 
Cohort 
B 
1 
9 
Pain vaccination 
site  
1 
11 
15-10-
2017 
15-10-
2017 
RSV26 
Cohort 
B 
1 
10 
Ulcer 
vaccination site 
2 
13 
17-10-
2017 
18-10-
2017 
RSV26 
Cohort 
B 
1 
11 
Pyuria 
5 
14 
18-10-
2017 
03-11-
2017 
RSV26 
Cohort 
B 
1 
12 
Vaccination site 
crust 
1 
11 
15-10-
2017 
13-01-
2018 
RSV26 
Cohort 
B 
1 
13 
Eosinophilia 
5 
30 
03-11-
2017 
05-12-
2017 
RSV26 
Cohort 
B 
1 
14 
Headache 
4 
56 
29-11-
2017 
29-11-
2017 
RSV26 
Cohort 
B 
1 
15 
Common cold 
4 
67 
10-12-
2017 
16-12-
2017 
RSV26 
Cohort 
B 
1 
16 
Hypercholestero
lemia 
5 
114 
26-01-
2018 
Continu
es 
RSV26 
Cohort 
B 
1 
17 
Increase in 
SGPT 
5 
114 
26-01-
2018 
Continu
es 
RSV26 
Cohort 
B 
1 
18 
Pyuria 
5 
180 
02-04-
2018 
Continu
es 
RSV26 
Cohort 
B 
1 
19 
Increase in 
SGOT 
5 
180 
02-04-
2018 
Continu
es 
RSV27 
Cohort 
B 
1 
1 
Induration 
vaccination site 
1 
14 
18-10-
2017 
20-10-
2017 
RSV27 
Cohort 
B 
1 
2 
Erythema 
vaccination site 
1 
1 
05-10-
2017 
06-10-
2017 
RSV27 
Cohort 
B 
1 
3 
Induration 
vaccination site 
1 
1 
05-10-
2017 
10-10-
2017 
RSV27 
Cohort 
B 
1 
4 
Pain vaccination 
site  
1 
0 
04-10-
2017 
17-10-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 57 - 
RSV27 
Cohort 
B 
1 
5 
Vaccine site 
sensitivity 
1 
0 
04-10-
2017 
14-10-
2017 
RSV27 
Cohort 
B 
1 
6 
Pruritus 
vaccination site 
2 
5 
09-10-
2017 
10-10-
2017 
RSV27 
Cohort 
B 
1 
7 
Erythema 
vaccination site 
1 
5 
09-10-
2017 
21-10-
2017 
RSV27 
Cohort 
B 
1 
8 
Vaccination site 
abscess 
1 
8 
12-10-
2017 
18-10-
2017 
RSV27 
Cohort 
B 
1 
9 
Vaccination site 
crust 
1 
14 
18-10-
2017 
09-03-
2018 
RSV27 
Cohort 
B 
1 
10 
Induration 
vaccination site 
1 
20 
24-10-
2017 
25-10-
2017 
RSV27 
Cohort 
B 
1 
11 
Hyperglycemia 
5 
63 
06-12-
2017 
26-01-
2018 
RSV27 
Cohort 
B 
1 
12 
Headache 
4 
113 
25-01-
2018 
25-01-
2018 
RSV27 
Cohort 
B 
1 
13 
Decreased 
haemoglobin 
5 
114 
26-01-
2018 
03-04-
2018 
RSV27 
Cohort 
B 
1 
14 
Proteinuria 
5 
181 
03-04-
2018 
Continu
es 
RSV30 
Cohort 
B 
1 
1 
Vaccine site 
sensitivity 
1 
0 
10-10-
2017 
12-10-
2017 
RSV30 
Cohort 
B 
1 
2 
Headache 
3 
0 
10-10-
2017 
18-10-
2017 
RSV30 
Cohort 
B 
1 
3 
Fatigue 
3 
1 
11-10-
2017 
11-10-
2017 
RSV30 
Cohort 
B 
1 
4 
Pruritus 
vaccination site 
2 
1 
11-10-
2017 
13-10-
2017 
RSV30 
Cohort 
B 
1 
5 
Hypertension 
3 
2 
12-10-
2017 
12-10-
2017 
RSV30 
Cohort 
B 
1 
6 
Left axillary pain 
2 
0 
10-10-
2017 
10-10-
2017 
RSV30 
Cohort 
B 
1 
7 
Vaccination site 
crust 
1 
11 
21-10-
2017 
26-10-
2017 
RSV30 
Cohort 
B 
1 
8 
Pain vaccination 
site  
1 
8 
18-10-
2017 
22-10-
2017 
RSV30 
Cohort 
B 
1 
9 
Vaccine site 
sensitivity 
1 
7 
17-10-
2017 
23-10-
2017 
RSV30 
Cohort 
B 
1 
10 
Headache 
3 
10 
20-10-
2017 
24-10-
2017 
RSV30 
Cohort 
B 
1 
11 
Myalgia 
3 
3 
13-10-
2017 
13-10-
2017 
RSV30 
Cohort 
B 
1 
12 
Myalgia 
3 
7 
17-10-
2017 
18-10-
2017 
RSV30 
Cohort 
B 
1 
13 
Myalgia 
3 
12 
22-10-
2017 
22-10-
2017 
RSV30 
Cohort 
B 
1 
14 
Vaccination site 
abscess 
1 
9 
19-10-
2017 
21-10-
2017 
RSV30 
Cohort 
B 
1 
15 
Myalgia 
3 
15 
25-10-
2017 
25-10-
2017 
RSV30 
Cohort 
B 
1 
16 
Myalgia 
3 
17 
27-10-
2017 
27-10-
2017 
RSV30 
Cohort 
B 
1 
17 
Myalgia 
3 
19 
29-10-
2017 
29-10-
2017 
RSV30 
Cohort 
B 
1 
18 
Pruritus 
vaccination site 
2 
17 
27-10-
2017 
30-10-
2017 
RSV30 
Cohort 
B 
1 
19 
Vaccination site 
crust 
1 
23 
02-11-
2017 
14-11-
2017 
RSV30 
Cohort 
B 
1 
20 
Common cold 
4 
34 
13-11-
2017 
18-11-
2017 
RSV30 
Cohort 
B 
1 
21 
Common cold 
4 
125 
12-02-
2018 
18-02-
2018 
RSV30 
Cohort 
B 
1 
22 
Decreased 
haemoglobin 
5 
174 
02-04-
2018 
Continu
es 
RSV32 
Cohort 
C 
1 
1 
Pain vaccination 
site  
1 
0 
21-11-
2017 
05-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 58 - 
RSV32 
Cohort 
C 
1 
2 
Vaccine site 
sensitivity 
1 
1 
22-11-
2017 
06-12-
2017 
RSV32 
Cohort 
C 
1 
3 
Erythema 
vaccination site 
1 
1 
22-11-
2017 
24-11-
2017 
RSV32 
Cohort 
C 
1 
4 
Headache 
3 
1 
22-11-
2017 
25-11-
2017 
RSV32 
Cohort 
C 
1 
5 
Fatigue 
3 
1 
22-11-
2017 
24-11-
2017 
RSV32 
Cohort 
C 
1 
6 
Pain vaccination 
site  
4 
1 
22-11-
2017 
22-11-
2017 
RSV32 
Cohort 
C 
1 
7 
Myalgia 
3 
2 
23-11-
2017 
24-11-
2017 
RSV32 
Cohort 
C 
1 
8 
Erythema 
vaccination site 
1 
5 
26-11-
2017 
01-12-
2017 
RSV32 
Cohort 
C 
1 
9 
Vaccination site 
abscess 
1 
6 
27-11-
2017 
27-11-
2017 
RSV32 
Cohort 
C 
1 
10 
Induration 
vaccination site 
1 
2 
23-11-
2017 
24-11-
2017 
RSV32 
Cohort 
C 
1 
11 
Induration 
vaccination site 
1 
6 
27-11-
2017 
28-11-
2017 
RSV32 
Cohort 
C 
1 
12 
Vaccination site 
crust 
1 
6 
27-11-
2017 
30-11-
2017 
RSV32 
Cohort 
C 
1 
13 
Vaccination site 
abscess 
1 
9 
30-11-
2017 
18-12-
2017 
RSV32 
Cohort 
C 
1 
14 
Erythema 
vaccination site 
1 
12 
03-12-
2017 
03-12-
2017 
RSV32 
Cohort 
C 
1 
15 
Erythema 
vaccination site 
1 
14 
05-12-
2017 
05-12-
2017 
RSV32 
Cohort 
C 
1 
16 
Induration 
vaccination site 
1 
9 
30-11-
2017 
30-11-
2017 
RSV32 
Cohort 
C 
1 
17 
Induration 
vaccination site 
1 
12 
03-12-
2017 
29-12-
2017 
RSV32 
Cohort 
C 
1 
18 
Vaccination site 
crust 
1 
11 
02-12-
2017 
17-06-
2018 
RSV32 
Cohort 
C 
1 
19 
Vaccination site 
abscess 
1 
10 
01-12-
2017 
05-12-
2017 
RSV32 
Cohort 
C 
1 
20 
Erythema 
vaccination site 
1 
19 
10-12-
2017 
10-12-
2017 
RSV32 
Cohort 
C 
1 
21 
Vaccination site 
abscess 
1 
16 
07-12-
2017 
16-12-
2017 
RSV32 
Cohort 
C 
1 
22 
Vaccine site 
sensitivity 
1 
20 
11-12-
2017 
13-12-
2017 
RSV32 
Cohort 
C 
1 
23 
Vaccination site 
abscess 
1 
28 
19-12-
2017 
03-03-
2018 
RSV32 
Cohort 
C 
1 
24 
Acute 
gastroenteritis 
4 
33 
24-12-
2017 
26-12-
2017 
RSV32 
Cohort 
C 
1 
25 
Decreased 
haemoglobin 
5 
62 
22-01-
2018 
20-03-
2018 
RSV32 
Cohort 
C 
1 
26 
Hypoglycemia 
5 
62 
22-01-
2018 
20-03-
2018 
RSV32 
Cohort 
C 
1 
27 
Hypertension 
4 
62 
22-01-
2018 
20-03-
2018 
RSV32 
Cohort 
C 
1 
28 
Common cold 
4 
149 
19-04-
2018 
22-04-
2018 
RSV32 
Cohort 
C 
1 
29 
Common cold 
4 
167 
07-05-
2018 
22-05-
2018 
RSV32 
Cohort 
C 
1 
30 
Hypoglycemia 
5 
174 
14-05-
2018 
Continu
es 
RSV32 
Cohort 
C 
1 
31 
Hyponatremia 
5 
174 
14-05-
2018 
Continu
es 
RSV33 
Cohort 
C 
1 
1 
Pain vaccination 
site  
1 
0 
21-11-
2017 
22-11-
2017 
RSV33 
Cohort 
C 
1 
2 
Vaccine site 
sensitivity 
1 
0 
21-11-
2017 
23-11-
2017 
RSV33 
Cohort 
C 
1 
3 
Fatigue 
3 
0 
21-11-
2017 
21-11-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 59 - 
RSV33 
Cohort 
C 
1 
4 
Erythema 
vaccination site 
1 
2 
23-11-
2017 
24-11-
2017 
RSV33 
Cohort 
C 
1 
5 
Puncture site 
ecchymosis 
4 
5 
26-11-
2017 
03-12-
2017 
RSV33 
Cohort 
C 
1 
6 
Vaccine site 
sensitivity 
1 
5 
26-11-
2017 
02-12-
2017 
RSV33 
Cohort 
C 
1 
7 
Headache 
3 
5 
26-11-
2017 
29-11-
2017 
RSV33 
Cohort 
C 
1 
8 
Vaccination site 
abscess 
1 
5 
26-11-
2017 
30-11-
2017 
RSV33 
Cohort 
C 
1 
9 
Vomiting 
3 
10 
01-12-
2017 
01-12-
2017 
RSV33 
Cohort 
C 
1 
10 
Diarrhea 
3 
10 
01-12-
2017 
01-12-
2017 
RSV33 
Cohort 
C 
1 
11 
Headache 
3 
10 
01-12-
2017 
02-12-
2017 
RSV33 
Cohort 
C 
1 
12 
Vaccination site 
crust 
1 
7 
28-11-
2017 
04-12-
2017 
RSV33 
Cohort 
C 
1 
13 
Vaccination site 
crust 
1 
15 
06-12-
2017 
30-12-
2017 
RSV33 
Cohort 
C 
1 
14 
Pain vaccination 
site  
1 
3 
24-11-
2017 
24-11-
2017 
RSV33 
Cohort 
C 
1 
15 
Pain vaccination 
site  
1 
6 
27-11-
2017 
02-12-
2017 
RSV33 
Cohort 
C 
1 
16 
Pain vaccination 
site  
1 
14 
05-12-
2017 
05-12-
2017 
RSV33 
Cohort 
C 
1 
17 
Hypokalemia 
5 
15 
06-12-
2017 
20-12-
2017 
RSV33 
Cohort 
C 
1 
18 
Erythema 
vaccination site 
1 
7 
28-11-
2017 
28-11-
2017 
RSV33 
Cohort 
C 
1 
19 
Erythema 
vaccination site 
1 
9 
30-11-
2017 
30-11-
2017 
RSV33 
Cohort 
C 
1 
20 
Induration 
vaccination site 
1 
7 
28-11-
2017 
28-11-
2017 
RSV33 
Cohort 
C 
1 
21 
Decreased 
hemoglobin 
5 
29 
20-12-
2017 
24-01-
2018 
RSV33 
Cohort 
C 
1 
22 
Increase in CPK 
5 
29 
20-12-
2017 
24-01-
2018 
RSV33 
Cohort 
C 
1 
23 
Vaccination site 
crust 
1 
42 
02-01-
2018 
05-02-
2018 
RSV33 
Cohort 
C 
1 
24 
Pyuria 
5 
119 
20-03-
2018 
18-05-
2018 
RSV33 
Cohort 
C 
1 
25 
Common cold 
4 
153 
23-04-
2018 
07-05-
2018 
RSV33 
Cohort 
C 
1 
26 
Common cold 
4 
170 
10-05-
2018 
25-05-
2018 
RSV34 
Cohort 
C 
2 
1 
Pain vaccination 
site  
1 
0 
21-11-
2017 
02-12-
2017 
RSV34 
Cohort 
C 
2 
2 
Vaccine site 
sensitivity 
1 
1 
22-11-
2017 
26-11-
2017 
RSV34 
Cohort 
C 
2 
3 
Erythema 
vaccination site 
1 
1 
22-11-
2017 
24-11-
2017 
RSV34 
Cohort 
C 
2 
4 
Induration 
vaccination site 
1 
2 
23-11-
2017 
23-11-
2017 
RSV34 
Cohort 
C 
2 
5 
Pruritus 
vaccination site 
2 
3 
24-11-
2017 
26-11-
2017 
RSV34 
Cohort 
C 
2 
6 
Headache 
3 
6 
27-11-
2017 
04-12-
2017 
RSV34 
Cohort 
C 
2 
7 
Decreased 
hemoglobin 
5 
7 
28-11-
2017 
06-12-
2017 
RSV34 
Cohort 
C 
2 
8 
Pruritus 
vaccination site 
2 
13 
04-12-
2017 
05-12-
2017 
RSV34 
Cohort 
C 
2 
9 
Proteinuria  
5 
15 
06-12-
2017 
21-12-
2017 
RSV34 
Cohort 
C 
2 
10 
Increase in 
SGOT 
5 
15 
06-12-
2017 
21-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
10-005 R02 20181024 
- 60 - 
RSV34 
Cohort 
C 
2 
12 
Fatigue 
3 
12 
03-12-
2017 
03-12-
2017 
RSV34 
Cohort 
C 
2 
13 
Myalgia 
3 
13 
04-12-
2017 
07-12-
2017 
RSV34 
Cohort 
C 
2 
14 
Sickness 
3 
19 
10-12-
2017 
13-12-
2017 
RSV34 
Cohort 
C 
2 
15 
Headache 
3 
15 
06-12-
2017 
08-12-
2017 
RSV34 
Cohort 
C 
2 
16 
Vaccination site 
abscess 
1 
13 
04-12-
2017 
04-12-
2017 
RSV34 
Cohort 
C 
2 
17 
Vaccination site 
abscess 
1 
30 
21-12-
2017 
20-02-
2018 
RSV34 
Cohort 
C 
2 
18 
Hypophosphate
mia 
5 
30 
21-12-
2017 
18-01-
2018 
RSV34 
Cohort 
C 
2 
19 
Decreased 
hemoglobin 
5 
30 
21-12-
2017 
18-01-
2018 
RSV34 
Cohort 
C 
2 
20 
Eosinophilia 
5 
30 
21-12-
2017 
18-01-
2018 
RSV34 
Cohort 
C 
2 
21 
Hyperbilirubine
mia 
5 
58 
18-01-
2018 
20-03-
2018 
RSV34 
Cohort 
C 
2 
22 
Hypoglycemia 
5 
58 
18-01-
2018 
20-03-
2018 
RSV34 
Cohort 
C 
2 
23 
Pain vaccination 
site  
1 
86 
15-02-
2018 
20-02-
2018 
RSV34 
Cohort 
C 
2 
24 
Pruritus 
vaccination site 
2 
86 
15-02-
2018 
26-02-
2018 
RSV34 
Cohort 
C 
2 
25 
Vaccination site 
crust 
1 
91 
20-02-
2018 
23-04-
2018 
RSV34 
Cohort 
C 
2 
26 
Headache 
4 
98 
27-02-
2018 
27-02-
2018 
RSV34 
Cohort 
C 
2 
27 
Eosinophilia 
5 
119 
20-03-
2018 
23-05-
2018 
RSV34 
Cohort 
C 
2 
28 
Thrombocytope
nia 
5 
119 
20-03-
2018 
23-05-
2018 
RSV34 
Cohort 
C 
2 
29 
increase in CPK 
5 
15 
06-12-
2017 
21-12-
2017 
RSV36 
Cohort 
C 
1 
1 
Vaccine site 
sensitivity 
1 
0 
27-11-
2017 
20-01-
2018 
RSV36 
Cohort 
C 
1 
2 
Headache 
3 
0 
27-11-
2017 
27-11-
2017 
RSV36 
Cohort 
C 
1 
3 
Erythema 
vaccination site 
1 
1 
28-11-
2017 
05-12-
2017 
RSV36 
Cohort 
C 
1 
4 
Pain vaccination 
site  
1 
1 
28-11-
2017 
08-12-
2017 
RSV36 
Cohort 
C 
1 
5 
Vaccination site 
abscess 
1 
4 
01-12-
2017 
05-12-
2017 
RSV36 
Cohort 
C 
1 
6 
Fatigue 
3 
4 
01-12-
2017 
01-12-
2017 
RSV36 
Cohort 
C 
1 
7 
Vaccination site 
crust 
1 
7 
04-12-
2017 
14-12-
2017 
RSV36 
Cohort 
C 
1 
8 
Decreased 
haemoglobin 
5 
8 
05-12-
2017 
02-01-
2018 
RSV36 
Cohort 
C 
1 
9 
Increase in CPK 
5 
8 
05-12-
2017 
11-12-
2017 
RSV36 
Cohort 
C 
1 
10 
Ulcer 
vaccination site 
2 
18 
15-12-
2017 
28-12-
2017 
RSV36 
Cohort 
C 
1 
11 
Urethritis 
4 
35 
01-01-
2018 
01-01-
2018 
RSV36 
Cohort 
C 
1 
12 
Increase in CPK 
5 
36 
02-01-
2018 
25-01-
2018 
RSV36 
Cohort 
C 
1 
13 
Vaccination site 
crust 
1 
32 
29-12-
2017 
30-01-
2018 
RSV36 
Cohort 
C 
1 
14 
Pyuria 
5 
59 
25-01-
2018 
27-03-
2018 
RSV36 
Cohort 
C 
1 
15 
Decreased 
haemoglobin 
5 
59 
25-01-
2018 
Continu
es 

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RSV36 
Cohort 
C 
1 
16 
Increase in 
SGOT 
5 
59 
25-01-
2018 
27-03-
2018 
RSV36 
Cohort 
C 
1 
17 
Increase in 
SGPT 
5 
59 
25-01-
2018 
27-03-
2018 
RSV36 
Cohort 
C 
1 
18 
Hypokalemia 
5 
120 
27-03-
2018 
28-05-
2018 
RSV38 
Cohort 
C 
2 
1 
Hypotension 
3 
0 
27-11-
2017 
27-11-
2017 
RSV38 
Cohort 
C 
2 
2 
Vaccine site 
sensitivity 
1 
0 
27-11-
2017 
01-12-
2017 
RSV38 
Cohort 
C 
2 
3 
Pain vaccination 
site  
1 
0 
27-11-
2017 
30-11-
2017 
RSV38 
Cohort 
C 
2 
4 
Erythema 
vaccination site 
1 
1 
28-11-
2017 
29-11-
2017 
RSV38 
Cohort 
C 
2 
5 
Pruritus 
vaccination site 
2 
2 
29-11-
2017 
02-12-
2017 
RSV38 
Cohort 
C 
2 
6 
Vaccine site 
sensitivity 
1 
6 
03-12-
2017 
04-01-
2018 
RSV38 
Cohort 
C 
2 
7 
Traumatic 
wound, left foot 
4 
5 
02-12-
2017 
09-01-
2018 
RSV38 
Cohort 
C 
2 
8 
Decreased 
haemoglobin 
5 
8 
05-12-
2017 
11-12-
2017 
RSV38 
Cohort 
C 
2 
9 
Increase in 
alkaline 
phosphatases 
5 
8 
05-12-
2017 
Continu
es 
RSV38 
Cohort 
C 
2 
10 
Pain vaccination 
site  
1 
8 
05-12-
2017 
21-12-
2017 
RSV38 
Cohort 
C 
2 
11 
Pruritus 
vaccination site 
2 
9 
06-12-
2017 
08-12-
2017 
RSV38 
Cohort 
C 
2 
12 
Common cold 
4 
11 
08-12-
2017 
22-12-
2017 
RSV38 
Cohort 
C 
2 
13 
Vaccination site 
abscess 
1 
8 
05-12-
2017 
07-12-
2017 
RSV38 
Cohort 
C 
2 
14 
Vaccination site 
crust 
1 
11 
08-12-
2017 
26-12-
2017 
RSV38 
Cohort 
C 
2 
15 
Vaccination site 
abscess 
1 
12 
09-12-
2017 
10-12-
2017 
RSV38 
Cohort 
C 
2 
16 
Vaccination site 
abscess 
1 
17 
14-12-
2017 
14-12-
2017 
RSV38 
Cohort 
C 
2 
17 
Headache 
3 
18 
15-12-
2017 
15-12-
2017 
RSV38 
Cohort 
C 
2 
18 
Fatigue 
3 
18 
15-12-
2017 
15-12-
2017 
RSV38 
Cohort 
C 
2 
19 
Ulcer 
vaccination site 
2 
30 
27-12-
2017 
05-01-
2018 
RSV38 
Cohort 
C 
2 
20 
Headache 
3 
26 
23-12-
2017 
23-12-
2017 
RSV38 
Cohort 
C 
2 
21 
Diarrhea 
3 
25 
22-12-
2017 
22-12-
2017 
RSV38 
Cohort 
C 
2 
22 
Vaccination site 
crust 
1 
39 
05-01-
2018 
21-01-
2018 
RSV38 
Cohort 
C 
2 
23 
Headache 
3 
16 
13-12-
2017 
13-12-
2017 
RSV38 
Cohort 
C 
2 
24 
Headache 
3 
23 
20-12-
2017 
20-12-
2017 
RSV38 
Cohort 
C 
2 
25 
Headache 
4 
161 
07-05-
2018 
07-05-
2018 
RSV38 
Cohort 
C 
2 
26 
Headache 
4 
182 
28-05-
2018 
28-05-
2018 
RSV40 
Cohort 
C 
1 
1 
Vaccine site 
sensitivity 
1 
0 
28-11-
2017 
16-12-
2017 
RSV40 
Cohort 
C 
1 
2 
Pain vaccination 
site  
1 
6 
04-12-
2017 
08-12-
2017 
RSV40 
Cohort 
C 
1 
3 
Erythema 
vaccination site 
1 
6 
04-12-
2017 
07-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
Version 0.3 
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RSV40 
Cohort 
C 
1 
4 
Induration 
vaccination site 
1 
8 
06-12-
2017 
06-12-
2017 
RSV40 
Cohort 
C 
1 
5 
Vaccination site 
abscess 
1 
6 
04-12-
2017 
31-12-
2017 
RSV40 
Cohort 
C 
1 
6 
Vaccination site 
crust 
1 
7 
05-12-
2017 
31-12-
2017 
RSV40 
Cohort 
C 
1 
7 
Increase in CPK 
5 
8 
06-12-
2017 
09-12-
2017 
RSV40 
Cohort 
C 
1 
8 
Decreased 
haemoglobin 
5 
11 
09-12-
2017 
30-01-
2018 
RSV40 
Cohort 
C 
1 
9 
Pain vaccination 
site  
1 
14 
12-12-
2017 
17-12-
2017 
RSV40 
Cohort 
C 
1 
10 
Tonsillitis 
4 
15 
13-12-
2017 
16-12-
2017 
RSV40 
Cohort 
C 
1 
11 
Contusion right 
hand 
4 
18 
16-12-
2017 
18-12-
2017 
RSV40 
Cohort 
C 
1 
13 
Erythema 
vaccination site 
1 
26 
24-12-
2017 
24-12-
2017 
RSV40 
Cohort 
C 
1 
14 
Ulcer 
vaccination site 
2 
34 
01-01-
2018 
15-01-
2018 
RSV40 
Cohort 
C 
1 
15 
Malaise   
3 
12 
10-12-
2017 
10-12-
2017 
RSV40 
Cohort 
C 
1 
16 
Diarrhea 
3 
29 
27-12-
2017 
27-12-
2017 
RSV40 
Cohort 
C 
1 
17 
Diarrhea 
4 
31 
29-12-
2017 
30-12-
2017 
RSV40 
Cohort 
C 
1 
18 
Headache 
3 
12 
10-12-
2017 
10-12-
2017 
RSV40 
Cohort 
C 
1 
19 
Myalgia 
3 
28 
26-12-
2017 
27-12-
2017 
RSV40 
Cohort 
C 
1 
20 
Diarrhea 
4 
35 
02-01-
2018 
02-01-
2018 
RSV40 
Cohort 
C 
1 
21 
Sickness 
4 
32 
30-12-
2017 
30-12-
2017 
RSV40 
Cohort 
C 
1 
22 
Common cold 
4 
29 
27-12-
2017 
15-01-
2018 
RSV40 
Cohort 
C 
1 
23 
Increase in CPK 
5 
36 
03-01-
2018 
30-01-
2018 
RSV40 
Cohort 
C 
1 
24 
Diarrhea 
4 
65 
01-02-
2018 
08-02-
2018 
RSV40 
Cohort 
C 
1 
26 
Anxiety 
4 
93 
01-03-
2018 
14-04-
2018 
RSV40 
Cohort 
C 
1 
27 
Insomnia 
4 
169 
16-05-
2018 
16-05-
2018 
RSV41 
Cohort 
C 
1 
1 
Vaccine site 
sensitivity 
1 
0 
28-11-
2017 
09-12-
2017 
RSV41 
Cohort 
C 
1 
2 
Pain vaccination 
site  
1 
1 
29-11-
2017 
30-11-
2017 
RSV41 
Cohort 
C 
1 
3 
Vaccination site 
abscess 
1 
2 
30-11-
2017 
02-12-
2017 
RSV41 
Cohort 
C 
1 
4 
Induration 
vaccination site 
1 
3 
01-12-
2017 
01-12-
2017 
RSV41 
Cohort 
C 
1 
5 
Vaccination site 
abscess 
1 
6 
04-12-
2017 
05-12-
2017 
RSV41 
Cohort 
C 
1 
6 
Pain vaccination 
site  
1 
7 
05-12-
2017 
07-12-
2017 
RSV41 
Cohort 
C 
1 
7 
Vaccination site 
crust 
1 
5 
03-12-
2017 
03-12-
2017 
RSV41 
Cohort 
C 
1 
8 
Decreased 
haemoglobin 
5 
8 
06-12-
2017 
Continu
es 
RSV41 
Cohort 
C 
1 
9 
Erythema 
vaccination site 
1 
8 
06-12-
2017 
06-12-
2017 
RSV41 
Cohort 
C 
1 
10 
Vaccination site 
crust 
1 
8 
06-12-
2017 
22-12-
2017 
RSV41 
Cohort 
C 
1 
11 
Urticaria 
4 
12 
10-12-
2017 
10-12-
2017 

rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
Confidential/Proprietary Information 
 
 
 
 
 
 
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RSV41 
Cohort 
C 
1 
12 
Headache 
3 
20 
18-12-
2017 
19-12-
2017 
RSV41 
Cohort 
C 
1 
13 
Vaccination site 
abscess 
1 
20 
18-12-
2017 
20-12-
2017 
RSV41 
Cohort 
C 
1 
14 
Vaccination site 
crust 
1 
26 
24-12-
2017 
08-02-
2018 
RSV41 
Cohort 
C 
1 
15 
Vaccine site 
sensitivity 
1 
25 
23-12-
2017 
25-12-
2017 
RSV41 
Cohort 
C 
1 
16 
Pain vaccination 
site  
1 
25 
23-12-
2017 
24-12-
2017 
RSV41 
Cohort 
C 
1 
17 
Common cold 
4 
45 
12-01-
2018 
29-01-
2018 
RSV41 
Cohort 
C 
1 
18 
Myalgia 
4 
49 
16-01-
2018 
18-01-
2018 
RSV41 
Cohort 
C 
1 
19 
Increase in 
SGOT 
5 
56 
23-01-
2018 
02-04-
2018 
RSV41 
Cohort 
C 
1 
20 
Increase in CPK 
5 
56 
23-01-
2018 
02-04-
2018 
RSV41 
Cohort 
C 
1 
21 
Tonsillitis 
4 
62 
29-01-
2018 
08-02-
2018 
RSV41 
Cohort 
C 
1 
22 
Common cold 
4 
72 
08-02-
2018 
07-03-
2018 
RSV41 
Cohort 
C 
1 
23 
Vaccination site 
crust 
1 
75 
11-02-
2018 
10-06-
2018 
RSV41 
Cohort 
C 
1 
24 
Hyperglycemia 
5 
125 
02-04-
2018 
28-05-
2018 
RSV41 
Cohort 
C 
1 
25 
Hypernatremia 
5 
125 
02-04-
2018 
28-05-
2018 
RSV41 
Cohort 
C 
1 
26 
Bronchitis 
4 
150 
27-04-
2018 
12-05-
2018 
RSV42 
Cohort 
C 
1 
1 
Vaccine site 
sensitivity 
1 
0 
04-12-
2017 
17-12-
2017 
RSV42 
Cohort 
C 
1 
2 
Pain vaccination 
site  
1 
1 
05-12-
2017 
10-12-
2017 
RSV42 
Cohort 
C 
1 
3 
Erythema 
vaccination site 
1 
1 
05-12-
2017 
06-12-
2017 
RSV42 
Cohort 
C 
1 
4 
Vaccination site 
abscess 
1 
2 
06-12-
2017 
11-12-
2017 
RSV42 
Cohort 
C 
1 
5 
General 
discomfort 
4 
1 
05-12-
2017 
06-12-
2017 
RSV42 
Cohort 
C 
1 
6 
Left axillary 
lymphadenopath
y 
1 
3 
07-12-
2017 
13-12-
2017 
RSV42 
Cohort 
C 
1 
7 
Headache 
3 
2 
06-12-
2017 
06-12-
2017 
RSV42 
Cohort 
C 
1 
8 
Erythema 
vaccination site 
1 
5 
09-12-
2017 
12-12-
2017 
RSV42 
Cohort 
C 
1 
9 
Hypotension 
3 
1 
05-12-
2017 
05-12-
2017 
RSV42 
Cohort 
C 
1 
10 
Pyuria 
5 
7 
11-12-
2017 
18-12-
2017 
RSV42 
Cohort 
C 
1 
11 
Vaccination site 
abscess 
1 
11 
15-12-
2017 
15-12-
2017 
RSV42 
Cohort 
C 
1 
12 
Vaccination site 
crust 
1 
7 
11-12-
2017 
23-03-
2018 
RSV42 
Cohort 
C 
1 
13 
Pyuria 
5 
25 
29-12-
2017 
03-01-
2018 
RSV42 
Cohort 
C 
1 
14 
Hematuria 
5 
25 
29-12-
2017 
03-01-
2018 
RSV42 
Cohort 
C 
1 
15 
Decreased 
hemoglobin 
5 
25 
29-12-
2017 
05-04-
2018 
RSV42 
Cohort 
C 
1 
16 
Proteinuria 
5 
30 
03-01-
2018 
07-02-
2018 
RSV42 
Cohort 
C 
1 
17 
Precordial pain 
secondary to 
supraventricular 
tachycardia 
4 
51 
24-01-
2018 
26-01-
2018 

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16 September 2019 
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rBCG-RSV Phase I Clinical Study Report 
16 September 2019 
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16. 
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Cautivo KM, Bueno SM, Cortes CM, Wozniak A, Riedel CA, Kalergis AM. Efficient lung 
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18. 
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Chen JJ, Chan P, Paes B, Mitchell I, Li A, Lanctôt KL, et al. Serious Adverse Events in 
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Whelan KT, Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, et al. Safety and 
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Bont L, Versteegh J, Swelsen WT, Heijnen CJ, Kavelaars A, Brus F, et al. Natural 
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Hall CB, Walsh EE, Long CE, Schnabel KC. Immunity to and frequency of reinfection 
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