A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
Phase: PHASE2
Conditions: COVID-19
Sponsor: ImmunityBio, Inc.

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
1 
TITLE PAGE  
A PHASE 2/3, PLACEBO-CONTROLLED, 
RANDOMIZED, OBSERVER-BLIND STUDY TO 
EVALUATE THE SAFETY, TOLERABILITY, 
IMMUNOGENICITY, AND EFFICACY OF A 2ND 
GENERATION E1/E2B/E3-DELETED ADENOVIRAL 
COVID-19 VACCINE: THE TCELLVACCINE TRIAL 
 
Study Number: 
COVID-3.001 
IND Sponsor: 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Lennie Sender, MD 
Medical Monitor 
ImmunityBio, Inc 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: lennie.sender@nantkwest.com 
Cell Phone: 714-615-2350 
 
Protocol Version 
Date 
Version 1 
16 November 2020 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
2 
STATEMENT OF COMPLIANCE 
This trial will be conducted in accordance with Good Clinical Practice (GCP) as described in the 
International Conference on Harmonization (ICH) Guideline for GCP (E6 [R2]) and in 
accordance with United States (US) Code of Federal Regulations (CFR) applicable to clinical 
studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) and the general 
ethical principles outlined in the Declaration of Helsinki. The study will receive approval from 
an Institutional Review Board (IRB) prior to commencement. The Principal Investigator will 
assure that no deviation from, or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the IRB, except where necessary to eliminate 
an immediate hazard(s) to the trial subjects.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
Signed: _____________________________________ Date: ______________ 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
3 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
ImmunityBio, Inc.  
Name of Investigational Products:  
1. hAd5-S-Fusion+N-ETSD 
Name of Active Ingredients: 
1. hAd5-S-Fusion+N-ETSD 
Title of Study:  
A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, 
Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral 
COVID-19 Vaccine: The TCELLVACCINE TRIAL 
Study Number: 
COVID-3.001 
Study Phase: 
Phase 2/3 
Rationale and Purpose:  
Introduction 
The emergence of the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-
CoV-2) in late 2019 has led to the current Coronavirus Infectious Disease 2019 (COVID-19) pandemic 
that has had a catastrophic impact on global healthcare systems and economies. The WHO declared the 
spread of SARS-CoV-2 infection a pandemic on March 11, 2020. As of November 2020, 50 million 
people have been infected with the virus, resulting in 1.2 million deaths globally. In the United States, 
the pandemic has reached a rate of over 100,000 newly diagnosed infections per day. The ongoing 
COVID-19 pandemic requires expedited timelines to develop COVID-19 vaccine candidates as well as 
to identify vaccine platforms that can be implemented rapidly to respond to the inevitable next 
pandemic. Currently, numerous vaccine candidates intended to prevent COVID-19 are in development 
globally. 
A failure to accomplish early control of SARS-CoV-2 infection in the respiratory tract results in high 
viral burden and continued shedding of virus, making individuals with such uncontrolled infection 
potential super-spreaders, particularly if they are asymptomatic and not in quarantine. A COVID-19 
vaccine that can induce both humoral and cell-mediated immunity (CMI) has the potential to provide 
early viral control by facilitating adaptive CMI activation. 
The Need to Induce T cell Response for Viral Clearance 
Vaccine candidates currently in clinical testing have focused on the SARS-CoV-2 wild type spike (S) 
protein (S-WT) as the major antigen of choice and while pre-clinical and early clinical testing have 
shown that S elicits an antibody response, we believe the optimal vaccine candidate should be capable 
of inducing robust, durable T-cell responses as well as humoral responses. Antibody responses to 
SARS-CoV-2 can be detected in most COVID-19 patients 10-15 days following symptom onset, but 
these antibody responses decline to baseline in many patients within 3 months. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
4 
These findings suggest that vaccines focused solely on eliciting neutralizing antibodies to the S protein 
may be insufficient to elicit durable long-term immunity or reduce morbidity associated with SARS-
CoV-2. We believe developing effective vaccines requires robust response from the adaptive immune 
system in order to ultimately clear the virus from infected cells. Evidence to support the notion that 
both T cells and antibodies are needed has been mounting since the outbreak of the pandemic.  
The Importance of Both S and N Proteins for Broad CD4+ and CD8+ Memory T Cell Response 
The importance of selecting SARS-CoV-2 vaccine antigens beyond the spike protein is supported by 
findings both from the outbreak of SARS-CoV in 2003 and the most recent reports on the importance 
of the nucleocapsid (N) protein found within the viral particle for T-cell activation in patients 
recovered from SARS-CoV-2. 
Ferretti et al. determined the precise peptide sequences in SARS-CoV-2 that are recognized by 
memory CD8+ T cells of COVID-19 patients. They reported that only 3 of 29 epitopes were located in 
the spike protein, with most epitopes located in ORF1 or the nucleocapsid protein. The importance of 
N for T-cell responses was also highlighted by Peng et al. in their 2006 report on immune responses to 
SARS-CoV wherein they stated in subjects who recovered from SARS-CoV, virus-N protein-specific 
memory CD8+ T cells persist for at least 11 years, while memory B cells and antiviral antibodies were 
largely undetectable at these later time points. This was confirmed by Ng et al., who also showed that 
memory T cell responses targeting the SARS coronavirus N-protein persist up to 11 years post-
infection.  
Specifically relevant for the current pandemic, Le Bert et al. showed that patients (n = 36) recovering 
from COVID-19 all had CD4+ and CD8+ T cells that recognized multiple regions of the N protein. Le 
Bert also looked at patients who recovered from SARS (the disease associated with SARS-CoV 
infection) and found they possess long-lasting memory T cells that are reactive to the N protein of 
SARS-CoV 17 years after the outbreak of SARS in 2003. These memory T cells from SARS-CoV 
patients displayed robust cross-reactivity to the N protein of SARS-CoV-2, reflecting the highly 
conserved nature of the N protein.  
Consistent with the findings of T-cell protection following SARS-CoV-1 infection, recent studies have 
demonstrated that in SARS-CoV-2, T cells play an important role independent of seroconversion, that 
is, antibody production. Recently, Sekine et al. reported that in convalescent individuals with 
asymptomatic or mild COVID-19, SARS-CoV-2 specific CD4+ and CD8+ T cells were identified and 
these T cells displayed an activated cytotoxic phenotype. Of significance was the finding of 
polyfunctional SARS-CoV-2 specific T cells in seronegative, asymptomatic individuals. Confirmation 
of the protective effect of T cells was provided by an English study of hospital workers and first 
responders, in which it was found that SARS-CoV-2 responsive T cell numbers were associated with 
protection from COVID-19. 
In further support of the merits of the addition of N as an antigen in our vaccine candidate to stimulate 
T-cell activation and provide protection even if antibody responses wane, is a concern that mutation of 
the spike protein may render neutralizing antibodies less effective. Recently, reports from Denmark 
and Scotland indicated that SARS-CoV-2 strains expressing mutated versions of spike have been 
identified and that anti-spike antibodies from convalescent sera are less effective in neutralizing these 
mutated SARS-CoV-2 viruses. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
5 
Rational Design of a COVID-19 Vaccine to Induce Humoral and Cell Mediated Immunity 
Based on the above knowledge and concerns, ImmunityBio has developed a second-generation 
COVID-19 vaccine, targeting not just spike (S), but also the highly antigenic and T-cell activating viral 
nucleocapsid protein. This COVID-19 vaccine, hAd5-S-Fusion+N-ETSD, is distinctive in multiple 
aspects of design including: (1) use of a second-generation adenovirus vector platform capable of 
delivering the transgene even in the presence of pre-existing adenovirus immunity; (2) targeting of both 
spike and nucleocapsid immunogenic SARS-CoV-2 proteins; (3) generation of enhanced antibody and 
CD4+/CD8+ T cell Th1 dominant immune activation responses by molecular trafficking of N to the 
endo/lysosomal compartment through the design of ETSD (Enhanced T cell Stimulating Domain); (4) 
suitability for delivery by multiple routes including subcutaneous, oral and intranasal to achieve 
mucosal, antibody and long-term cell mediated immunity; and (5) practicality of storage such as 
refrigerated and room temperature stable formulations that overcome cold-chain limitations. Further 
details are provided in Appendix 5. 
The purpose and goals of the hAd5-S-Fusion+N-ETSD vaccine are to: 
1. Reduce transmission by viral clearance from lung and nasal airways. Data from NHP 
challenge studies showed that viral replication was undetectable within days of SARS-CoV-2 
challenge (10E6 TCID50) in samples from both lung and nasal passages, following hAd5-S-
Fusion+N-ETSD immunization. 
2. Induce innate and adaptive immunity by selection of antigens with maximum epitopes for 
MHC-1 and MHC-2 presentation. Several studies have now shown that S and N proteins 
provide the opportunity for the broadest CD4+ and CD8+ T cell response. Preclinical 
immunogenicity data provide evidence for Th1 dominant cell immune response following 
hAd5-S-Fusion+N-ETSD immunization.  
3. Generate long-term durable immune protection. By directing N to the lysosomal 
intracellular compartment, Th1 dominant CD4+ T helper cell and CD8+ T cells immune 
responses are enhanced. Both immune recall studies using T cells from patients previously 
infected with SARS-CoV-2 and preclinical studies in mice show CD4+ and CD8+ memory T 
cell responses are triggered by the hAd5-S-Fusion+N-ETSD antigens.  
4. Reduce incidence of mild-to-moderate infection by stimulating an antibody, innate, adaptive 
and mucosal immune response. hAd5-S-Fusion+N-ETSD is designed to accomplish this 
response by both blocking entry of the virus and enabling rapid viral clearance via the innate 
and adaptive immune system. The Phase 2/3 randomized placebo controlled double-blind trial 
has been designed to test this hypothesis. 
5. Reduce severe disease, hospitalization time, admission to ICU, and mortality by 
stimulating an antibody, innate, adaptive and mucosal immune responses. hAd5-S-Fusion+N-
ETSD is designed to accomplish this response by both blocking entry of the virus and enabling 
rapid viral clearance via the innate and adaptive immune system. The Phase 2/3 randomized 
placebo controlled double-blind trial has been designed to test this hypothesis. 
6. Utilization of a platform with minimal side effects, scalability for rapid production, and 
that overcomes cold chain distribution challenges. The second-generation adenovirus 5 vector 
has been administered in over 150 cancer patients without serious adverse events when 
administered repeatedly at doses as high as 5x1011. The Phase 1 study of hAd5-S-Fusion+N-

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
6 
ETSD at doses of 5x1010 and 1x1010 were well tolerated in the first in human study with only 
grade 1 and grade 2 adverse events with no SAE reported. The vaccine is stable at 2-8 C and 
the oral formulation is stable at room temperature. Further details are provided in Appendix 4. 
7. Utilization of a platform that is able to deliver antigens in the presence of pre-existing Ad 
immunity. Compared to current adenovirus vector platforms in Phase 3 clinical trials for 
COVID-19, ImmunityBio’s hAd5 has four deletions, enabling delivery of the transgene 
COVID-19 proteins even in the presence of pre-existing adenovirus immunity. Clinical studies 
in cancer patients have shown the capability of hAd5-vectored cancer-related antigens (CEA, 
brachyury, etc.) to induce CD4+ and CD8+ T cell responses following multiple subcutaneous 
injections of hAd5 vaccine in patients with proven adenoviral immunity. 
On October 13, 2020, FDA authorized a Phase 1 study of hAd5-S-Fusion+N-ETSD and both doses of 
5×1010 VP/dose (n=10) and 1×1011 VP/dose (n=10) were administered subcutaneously without any 
SAEs or grade ≥3 AEs reported thus far. The most common AEs have been injection site redness, 
reaction, and pain, and fatigue, all of which were grade 1 or 2. The SRC met and confirmed the safety 
of the dose of 1×1011 VP/dose. The SRC report is attached in Appendix 4. On the basis of these safety 
findings, ImmunityBio will proceed with the 1×1011 VP/dose prime/boost in the phase 2/3 trial. 
Objectivesa 
Estimands 
Endpoints 
Primary Efficacy 
1. To evaluate the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed COVID-19 in 
subjects without serological 
or virological evidence of 
infection before vaccination 
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 14 
days after receipt of the last dose 
of study intervention: 
Vaccine Efficacy (VE) defined 
as 100% × (1 – IRR) [ratio of 
active vaccine to placebo] 
COVID-19 incidence based on 
central laboratory or locally 
confirmed nucleic acid 
amplification test (NAAT) in 
subjects with no serological or 
virological evidence (up to 
14 days after receipt of the last 
dose) of past SARS-CoV-2 
infection 
2. To evaluate the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed COVID-19 in 
subjects with and without 
serological or virological 
evidence of infection before 
vaccination 
 
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 
14 days after receipt of the last 
dose of study intervention: 
VE = 100% × (1 – IRR) [ratio of 
active vaccine to placebo] 
 
COVID-19 incidence based on 
central laboratory or locally 
confirmed NAAT in subjects 
with and without serological or 
virological evidence of infection 
before vaccination 
 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
7 
Primary Safety 
1. To define the safety profile 
of prophylactic hAd5-S-
Fusion+N-ETSD in the first 
200 subjects randomized 
(Phase 2) 
In subjects receiving at least 1 
dose of study intervention 
(safety analysis population), the 
percentage of subjects reporting: 
• 
Local reactions for up to 7 
days following each dose 
• 
Systemic events for up to 7 
days following each dose 
• 
AEs from Dose 1 to 7 days 
after the last dose 
• 
SAEs from Dose 1 to 7 days 
after the last dose 
• 
Local reactions (pain at the 
injection site, redness, and 
swelling) 
• 
Systemic events (fever, 
fatigue, headache, chills, 
vomiting, diarrhea, new or 
worsened muscle pain, and 
new or worsened joint pain) 
• 
AEs 
• 
SAEs 
2. To define the safety profile 
of prophylactic hAd5-S-
Fusion+N-ETSD in all 
subjects randomized in 
Phase 2/3 
In subjects receiving at least 
1 dose of study intervention 
(safety analysis population), the 
percentage of subjects reporting: 
• 
Local reactions for up to 
7 days following each dose 
• 
Systemic events for up to 
7 days following each dose 
• 
AEs from Dose 1 to 
1 month after the last dose 
• 
SAEs from Dose 1 to 
6 months after the last dose 
• 
AEs 
• 
SAEs 
• 
In a subset of at least 
1,000 subjects: 
o Local reactions (pain at 
the injection site, 
redness, and swelling) 
o Systemic events (fever, 
fatigue, headache, 
chills, vomiting, 
diarrhea, new or 
worsened muscle pain, 
and new or worsened 
joint pain) 
Secondary Efficacy 
1. To evaluate the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed severe COVID-
19 in subjects without 
serological or virological 
evidence of infection before 
vaccination 
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 
14 days after receipt of the last 
dose of study intervention: 
VE = 100% × (1 – IRR) [ratio of 
active vaccine to placebo] 
Confirmed NAAT severe 
COVID-19 incidence in subjects 
with no serological or 
virological evidence of past 
SARS-CoV-2 infection 
2. To evaluate the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed severe COVID-
19 in subjects with and 
without serological or 
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 
14 days after receipt of the last 
dose of study intervention:  
VE = 100% × (1 – IRR) [ratio of 
active vaccine to placebo]  
Confirmed NAAT severe 
COVID-19 incidence in subjects 
with and without serological or 
virological evidence of infection 
before vaccination 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
8 
virological evidence of 
infection before vaccination  
3. To describe the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed COVID-19 
(according to the CDC-
defined symptoms) in 
subjects without serological 
or virological evidence of 
infection before vaccination  
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 
14 days after receipt of the last 
dose of study intervention:  
VE = 100% × (1 – IRR) [ratio of 
active vaccine to placebo]  
COVID-19 incidence based on 
central laboratory or locally 
confirmed (according to the 
CDC-defined symptoms) in 
subjects with no serological or 
virological evidence (up to 
14 days after receipt of the last 
dose) of past SARS-CoV-2 
infection  
4. To describe the efficacy of 
prophylactic hAd5-S-
Fusion+N-ETSD against 
confirmed COVID-19 
(according to the CDC-
defined symptoms) in 
subjects with and without 
serological or virological 
evidence of infection before 
vaccination  
In subjects complying with the 
key protocol criteria (evaluable 
efficacy population) at least 
14 days after receipt of the last 
dose of study intervention:  
VE = 100% × (1 – IRR) [ratio of 
active vaccine to placebo]  
COVID-19 incidence based on 
central laboratory or locally 
confirmed (according to the 
CDC-defined symptoms) in 
subjects with and without 
serological or virological 
evidence of infection before 
vaccination  
Exploratory (up to 500 subjects) 
1. To evaluate the humoral 
immune response over time 
to prophylactic hAd5-S-
Fusion+N-ETSD and 
persistence of immune 
response in subjects with 
and without serological or 
virological evidence of 
SARS-CoV-2 infection 
before vaccination  
GMC, GMT, GMFR, percentage 
of subjects with titers greater 
than defined threshold(s), and 
neutralizing antibody titer 
demonstrated by ACE2 
inhibition at baseline and 
specific times during the study, 
as noted in the Schedule of 
Events  
• S-binding IgG levels 
• N-binding IgG levels 
• SARS-CoV-2 neutralizing 
antibody by cPass assay 
in subjects with and without 
serological or virological 
evidence of infection before 
vaccination 
2. To evaluate the humoral 
immune response over time 
to prophylactic hAd5-S-
Fusion+N-ETSD and 
persistence of immune 
response in subjects with 
serological or virological 
evidence of SARS-CoV-2 
infection before vaccination 
GMC, GMT, GMFR, percentage 
of subjects with titers greater 
than defined threshold(s), and 
neutralizing antibody titer 
demonstrated by ACE2 
inhibition at baseline and 
specific times during the study, 
as noted in the Schedule of 
Events 
• S-binding IgG levels 
• N-binding IgG levels 
• SARS-CoV-2 neutralizing 
antibody by cPass assay 
• in subjects with serological 
or virological evidence of 
SARS-CoV-2 infection 
3. To evaluate the cellular 
immune stimulatory 
efficacy, persistence, and 
duration of prophylactic 
hAd5-S-Fusion+N-ETSD 
cellular immunity against 
Memory immune CD4+ and 
CD8+ T cell stimulation from 
baseline to specific times during 
the study, as noted in the 
Schedule of Events 
• SARS-CoV-2 specific 
memory CD4+ and CD8+ T-cell 
stimulation to N and S proteins 
based on central laboratory or 
locally confirmed NAAT in 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
9 
confirmed SARS-CoV-2 in 
subjects with and without 
serological or virological 
evidence of infection before 
vaccination 
subjects with and without 
serological or virological 
evidence of infection before 
vaccination 
4. To evaluate the cellular 
immune stimulatory 
efficacy, persistence, and 
duration of prophylactic 
hAd5-S-Fusion+N-ETSD 
cellular immunity against 
confirmed SARS-CoV-2 in 
subjects with serological or 
virological evidence of 
infection before vaccination 
Memory immune CD4+ and 
CD8+ T cell stimulation from 
baseline to specific times during 
the study, as noted in the 
Schedule of Events 
• SARS-CoV-2 specific 
memory CD4+ and CD8+ T-cell 
stimulation to N and S proteins 
based on central laboratory or 
locally confirmed NAAT in 
subjects with serological or 
virological evidence of SARS-
CoV-2 infection 
5. To describe the safety, 
immunogenicity, and 
efficacy of prophylactic 
hAd5-S-Fusion+N-ETSD in 
individuals with confirmed 
stable HIV disease 
 
• All safety, immunogenicity, 
and efficacy endpoints 
described above  
a HIV-positive and participants who develop immunosuppressive related diseases (eg, cancer, 
autoimmune disease) in Phase 3 will not be included in analyses of the objectives, with the exception 
of the specific exploratory objective. 
Study Design: 
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the 
safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against 
COVID-19. The study schema is shown in Figure 1. Subjects will be ≥ 16 years of age who are healthy 
or have medically-stable chronic diseases and are at increased risk for SARS-CoV-2 infection and 
COVID-19. Approximately 20,700 subjects will be randomized in a 1:1 ratio to receive 2 subcutaneous 
(SC) doses of either 1× 1011 viral particles (VP)/dose hAd5-S-Fusion+N-ETSD or placebo 3 weeks 
apart, on Days 1 and 22. Randomization will be stratified by age (16 to 55 years or >55 years). It is 
intended that a minimum of 25% of subjects will be in the >55-year stratum. Safety, immunogenicity, 
and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected 
to participate for up to a maximum of approximately 2 years. 
The first 200 subjects randomized will comprise the phase 2 portion of the study. Safety data through 
7 days after Dose 2 from these 200 subjects will be analyzed by an independent statistical team and 
reviewed by the DMC. Enrollment may continue during this period and these subjects would be 
included in the phase 3 portion of the study.  
Enrollment (planned):   
Approximately 20,700 subjects will be randomized in this study. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
10 
Eligibility Criteria:  
Inclusion Criteria: 
Subjects are eligible to be included in the study only if all of the following criteria apply: 
Age and Sex:  
1. Male or female participants ≥16 years of age, at randomization.  
• 
Refer to Appendix 2 for reproductive criteria for male and female participants.  
Type of Participant and Disease Characteristics:  
2. Participants who are willing and able to comply with all scheduled assessments, vaccination 
plan, laboratory tests, lifestyle considerations, and other study procedures.  
3. Healthy participants who are determined by medical history, physical examination (if 
required), and clinical judgment of the investigator to be eligible for inclusion in the study.  
Note: Healthy participants with preexisting stable disease, defined as disease not requiring 
significant change in therapy or hospitalization for worsening disease during the 6 weeks 
before enrollment, can be included. Specific criteria for Phase 3 participants with known stable 
infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B 
virus (HBV) can be found in Appendix 3.  
4. Participants who, in the judgment of the investigator, are at higher risk for SARS-CoV-2 
infection and subsequent development of COVID-19 (including, but not limited to, use of mass 
transportation, relevant demographics, and frontline essential workers).  
Informed Consent:  
5. Capable of giving personal signed informed consent, which includes compliance with the 
requirements and restrictions listed in the informed consent document (ICD) and in this 
protocol. 
Exclusion Criteria: 
Participants are excluded from the study if any of the following criteria apply: 
Medical Conditions:  
1. Other medical or psychiatric condition including recent (within the past year) or active suicidal 
ideation/behavior or laboratory abnormality that may increase the risk of study participation or, 
in the investigator’s judgment, make the participant inappropriate for the study. 
2. Phase 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus 
(HCV), or hepatitis B virus (HBV). 
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, 
anaphylaxis) to any component of the study intervention(s). 
4. Receipt of medications intended to prevent COVID-19. 
5. Previous clinical or microbiological diagnosis of COVID-19. 
6. Immunocompromised individuals with known or suspected immunodeficiency, as determined 
by history and/or laboratory/physical examination. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
11 
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion 
of the investigator, contraindicate subcutaneous injection. 
8. Women who are pregnant or breastfeeding.  
Prior/Concomitant Therapy:  
9. Previous vaccination with any coronavirus vaccine. 
10. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents 
or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt 
throughout the study. If systemic corticosteroids have been administered short term (<14 days) 
for treatment of an acute illness, participants should not be enrolled into the study until 
corticosteroid therapy has been discontinued for at least 28 days before study intervention 
administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 
corticosteroids are permitted. 
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention 
administration or planned receipt throughout the study. 
Prior/Concurrent Clinical Study Experience:  
12. Participation in other studies involving study intervention within 28 days prior to study entry 
and/or during study participation. 
Other Exclusions 
13. Investigator site staff or Sponsor employees directly involved in the conduct of the study, site 
staff otherwise supervised by the investigator.  
Investigational Product, Dosage, and Mode of Administration:  
hAd5-S-Fusion+N-ETSD, 1 × 1011 VP/dose, SC 
Comparator: Placebo, SC 
Duration of Treatment:  
Subjects will be treated with hAd5-S-Fusion+N-ETSD or placebo on Days 1 and 22 (ie, 2 doses total 
of assigned intervention).   
Duration of Follow-up: 
Subjects are expected to participate for up to a maximum of approximately 2 years. 
Evaluation of Endpoints: 
Safety: Safety endpoints include assessments of reactogenicity events, AEs, and SAEs.  
Efficacy: The first primary efficacy endpoint is COVID-19 incidence based on central laboratory or 
locally confirmed NAAT in subjects with no serological or virological evidence (up to 14 days after 
receipt of the last dose) of past SARS-CoV-2 infection. 
The secondary primary endpoint is COVID-19 incidence based on central laboratory or locally 
confirmed NAAT in subjects with and without evidence of infection before vaccination. 
Immunogenicity:  Humoral immune response will be evaluated by S-binding IgG levels, N-binding 
IgG levels, and SARS-CoV-2 neutralizing antibody by cPass assay. Cellular immune response will be 
evaluated by SARS-CoV-2 specific memory CD4+ and CD8+ T-cell stimulation to N and S proteins. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
12 
Statistical Methods: 
Primary Efficacy Endpoints: The first primary efficacy endpoint is COVID-19 incidence based on 
central laboratory or locally confirmed NAAT in subjects with no serological or virological evidence 
(up to 14 days after receipt of the last dose) of past SARS-CoV-2 infection and will be summarized in 
terms of VE = 100% × (1 – IRR) [ratio of active vaccine to placebo].  
After the above first primary endpoint is met, the second primary endpoint will be evaluated. 
The second primary endpoint COVID-19 incidence based on central laboratory or locally confirmed 
NAAT in subjects with and without evidence of infection before vaccination.  
Sample Size: The first 200 subjects randomized in the study will be included in phase 2. Phase 2 
subjects will be included in the phase 3 portion of the study. 
For phase 3, ~20,700 subjects will be randomized in a 1:1 ratio to either the hAd5-S-Fusion+N-ETSD 
or placebo. All randomized subjects who received at least one dose of study intervention will included 
in the all-available efficacy population. The primary efficacy analysis will be based on the evaluable 
efficacy population which will include subjects in the all-available efficacy population who receive all 
planned doses of vaccine per schedule and have no major protocol deviations judged to effect efficacy.   
The phase 3 sample size calculation is based on the primary efficacy endpoints and derived from the 
exact conditional test under the Poisson assumption which is appropriate for large trials where the 
illness rate is very low and hypothesis testing is based on a non-zero lower bound (Chan 1998). The 
null and alternative hypotheses for the primary efficacy analyses are: 
  
Ho: VE ≤ 30% 
 
Ha: VE > 30% 
Under the assumption that the true VE is 60%, the primary efficacy analysis will require ~160 
confirmed COVID-19 illness cases which will provide 90% power to conclude the true VE is > 30%. 
Assuming the placebo illness rate is 1.3%, ~17,600 subjects will be required in the evaluable efficacy 
population for the primary efficacy analyses. These calculations are based a one-sided Type I error rate 
of 0.025. Assuming 15% of the all-available efficacy population will be unevaluable for the evaluable 
efficacy population, ~20,700 subjects will be sufficient to accrue ~17,600 subjects in the evaluable 
efficacy population. 
Dependent upon the evolution of the pandemic, it is possible that the COVID-19 illness rate may 
change as the study progresses. An increase in illness rate could accelerate case accrual allowing the 
primary endpoints to be evaluated sooner, whereas a decrease in illness rate could slow down case 
accrual delaying the evaluation. At the time of the first interim efficacy analysis, the independent 
statistical team and DMC will evaluate the placebo illness rate. If the upper bound of the two-sided 
95% CI for the observed placebo illness rate is less than the assumed placebo illness rate, then the 
sample size will be re-estimated by the independent statistician and DMC based on the observed 
placebo illness rate, and recommendations made to the Sponsor for final decision by the Sponsor.  
Primary Efficacy Analysis: The primary efficacy endpoints will be analyzed at 2 interim analyses and 
the final analysis. The interim analyses will be conducted by the independent statistical team and 
reviewed by the independent DMC. The Lan-DeMets/O’Brien-Fleming alpha(α)-spending function 
(Lan 1983, O'Brien 1979) will be used to control the overall Type I error at one-sided 0.025 level. At 
each analysis, VE will be summarized by the one-sided (1-α)100% CI. The table below summarizes the 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
13 
information fraction (ie, % of total cases), nominal α, criterion for success, and cumulative probability 
of success if the true VE is 60% for each analysis: 
 
Analysis 
Information 
Fraction (% 
of Total 
Cases) 
 
α 
 
Success Criterion 
Cumulative 
Probability of 
Success (if true 
VE=60%) 
Interim #1 
40% (64 
cases) 
0.0004 Point estimate of VE ≥ 50% and 
lower bound of the one-sided 
99.96% CI for VE is > 30% 
9.9% 
Interim #2 
70% (112 
cases) 
0.0073 Point estimate of VE ≥ 50% and 
lower bound of the one-sided 
99.27% CI for VE is > 30% 
61.5% 
Final 
100% (160 
cases) 
0.0227 Point estimate of VE ≥ 50% and 
lower bound of the one-sided 
97.73% CI for VE is > 30% 
90.0% 
 
Should the primary endpoint(s) show success at either interim analysis, the Sponsor will decide after 
discussion with FDA to explore the options to expedite submission of the data for approval and 
possible early closure of the trial, with long-term follow up of patients already enrolled. 
The study may be stopped early for futility (lack of benefit) at either interim analysis if the conditional 
power for the first primary endpoint is less than 5% (Jennison 2000). 
A Poisson regression model with robust error variance will be used to estimate VE and its one-sided 
(1-α)100% CI (Zou 2004). 
Safety Analyses: Safety analyses will be based on the safety analysis population and subjects will be 
analyzed according to the actual study intervention received. Descriptive statistics will be provided for 
each reactogenicity endpoint for the active vaccine group and the placebo group. Local reactions and 
systemic events from Day 1 through Day 7 after each vaccination will be presented overall and by 
severity. 
AEs and SAEs will be categorized according to the MedDRA terms. Descriptive statistics will be 
provided for each AE for the active vaccine group and the placebo group. For phase 2, AEs and SAEs 
will be presented for first vaccination through 7 days after last vaccination overall and by severity. For 
phase 3, AEs will be presented for first vaccination through 1 month after last vaccination and SAEs 
will be presented for first vaccination through 6 months after last vaccination overall and by severity. 
Immunogenicity Analyses: Immunogenicity analyses will be based on the immunogenicity analysis 
population and subjects will be analyzed according to the actual study intervention received. Humoral 
immune response endpoints will be summarized descriptively for the vaccine and placebo groups by 
GMT, GMC, GMFR, percentage of subjects with titers greater than defined threshold(s), and 
neutralizing antibody titer demonstrated by ACE2 inhibition at baseline and specific times during the 
study, as noted in the Schedule of Events. Cellular immune response endpoints will be summarized 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
14 
descriptively for the vaccine and placebo groups at baseline and specific times during the study, as 
noted in the Schedule of Events. 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
15 
Figure 1: 
Study Schema 
 

hAd5-COVID-19-PS  
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
Confidential and Proprietary 
73 
Table 8: 
Schedule of Events 
Patient Assessment 
Number 
1 
2 
3 
4 
5 
6 
Unplanned 
Unplanned 
Activity Description 
First 
Vaccination 
Second 
Vaccination 
1-Month
Follow-up
Assessment
6-Month
Follow-up
Assessment
12-Month
Follow-up
Assessment
24-Month
Follow-Up
Assessment
Potential COVID-
19 Illness 
Assessment 
Potential COVID-
19 Convalescent 
Assessment 
Assessment Window 
(Days) 
Day 1a 
19 to 23 
Days After 
Assessment 1 
28 to 35 
Days After 
Assessment 2 
175 to 189 
Days After 
Assessment 2 
350 to 378 
Days After 
Assessment 2 
714 to 742 
Days After 
Assessment 2 
Optimally Within 
3 Days After 
Potential COVID-
19 Illness Onset 
28 to 35 Days 
After Potential 
COVID-19 Illness 
Assessment 
Informed consent 
X 
Assign subject number 
X 
Demographics 
X 
Medical history 
X 
Perform clinical 
assessmentb 
X 
Measure height/weight 
X 
Measure temperature 
(body) 
X 
X 
Perform pregnancy test 
(if appropriate) 
X 
X 
Confirm use of 
contraceptives (if 
appropriate) 
X 
X 
X 
Collect nonstudy 
vaccine information 
X 
X 
X 
X 
Collect prohibited 
medication use 
X 
X 
X 
X 
X 
X 
X 
Confirm eligibility 
X 
X 

hAd5-COVID-19-PS  
 
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
74 
Patient Assessment 
Number 
1 
2 
3 
4 
5 
6 
Unplanned 
Unplanned 
Activity Description 
First 
Vaccination 
Second 
Vaccination 
1-Month 
Follow-up 
Assessment 
6-Month 
Follow-up 
Assessment 
12-Month 
Follow-up 
Assessment 
24-Month 
Follow-Up 
Assessment 
Potential COVID-
19 Illness 
Assessment 
Potential COVID-
19 Convalescent 
Assessment 
Assessment Window 
(Days) 
Day 1a 
19 to 23  
Days After 
Assessment 1 
28 to 35  
Days After 
Assessment 2 
175 to 189 
Days After 
Assessment 2 
350 to 378  
Days After 
Assessment 2 
714 to 742 
Days After 
Assessment 2 
Optimally Within 
3 Days After 
Potential COVID-
19 Illness Onset 
28 to 35 Days 
After Potential 
COVID-19 Illness 
Assessment 
Review temporary delay 
criteria 
X 
X 
 
 
 
 
 
 
Serum sample for 
SARS-CoV-2 serology 
testing 
X 
 
 
 
 
 
 
X 
Collect biospecimen 
(eg, nasal [midturbinate] 
swab) for SARS-CoV-2 
testing 
X 
X 
 
 
 
 
X 
 
Obtain randomization 
number and study 
intervention allocation 
X 
 
 
 
 
 
 
 
Administer study 
intervention 
X 
X 
 
 
 
 
 
 
Assess acute reactions 
for at least 30 minutes 
after study intervention 
administration 
X 
X 
 
 
 
 
 
 
Explain subject 
communication methods 
(including for e-diary 
completion) 
X 
 
 
 
 
 
 
 

hAd5-COVID-19-PS  
 
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
 
Confidential and Proprietary 
75 
Patient Assessment 
Number 
1 
2 
3 
4 
5 
6 
Unplanned 
Unplanned 
Activity Description 
First 
Vaccination 
Second 
Vaccination 
1-Month 
Follow-up 
Assessment 
6-Month 
Follow-up 
Assessment 
12-Month 
Follow-up 
Assessment 
24-Month 
Follow-Up 
Assessment 
Potential COVID-
19 Illness 
Assessment 
Potential COVID-
19 Convalescent 
Assessment 
Assessment Window 
(Days) 
Day 1a 
19 to 23  
Days After 
Assessment 1 
28 to 35  
Days After 
Assessment 2 
175 to 189 
Days After 
Assessment 2 
350 to 378  
Days After 
Assessment 2 
714 to 742 
Days After 
Assessment 2 
Optimally Within 
3 Days After 
Potential COVID-
19 Illness Onset 
28 to 35 Days 
After Potential 
COVID-19 Illness 
Assessment 
Provide/ensure the 
subject has a 
thermometer (all 
subjects) and measuring 
devicec 
X 
X 
 
 
 
 
 
 
Review reactogenicity 
e-diary datac 
 
 
 
 
 
 
 
 
Review ongoing 
reactogenicity e-diary 
symptomsc 
 
X 
X 
 
 
 
 
 
Collect AEs and SAEs 
as appropriate 
X 
X 
X 
Xd 
Xd 
Xd 
X 
Xd 
Collection of COVID-
19–related clinical and 
laboratory information 
(including local 
diagnosis) 
 
 
 
 
 
 
X 
X 
a The assessment may be conducted across 2 consecutive days; if so, all steps from assessing the inclusion and exclusion criteria onwards must be conducted on 
the same day. 
b Including, if indicated, a physical examination. 
c Reactogenicity subset subjects only. 
d Any AEs occurring up to 48 hours after the blood draw must be recorded. 
 

hAdS-COVID-19-PS 
ImmunityBio, Inc. 
Clinical Trial Protocol: COVID-3.001 
APPENDIX 6. SPONSOR SIGNATURE 
Study Title: 
A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind 
Study To Evaluate the Safety, Tolerability, Immunogenicity, and 
Efficacy of a 2"d Generation El/E2B/E3-Deleted Adenoviral 
COVID-19Vaccine: The TCELLVACCINE TRIAL 
Study Number: 
COVID-3.001 
Version Number: 
1 
Final Date: 
16 November 2020 
This clinical trial protocol was subject to critical review and has been approved by Immunity Bio. 
The following personnel contributed to writing and/or approving this protocol: 
Signed: 
Lennie Sender, MD 
Medical Monitor 
ImmunityBio, Inc 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: lennie.sender@nantkwest.com 
Cell Phone: 714-615-2350 
Confidential and Proprietary 
Date: 
177