Covid19
Conditions
Brief summary
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future studies.
Interventions
BIOLOGICALhAd5-S-Fusion+N-ETSD (Suspension for injection)
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
DRUGhAd5-SFusion+ N-ETSD (Oral capsule)
The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
Sponsors
ImmunityBio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults, age 18 - 55 years, inclusive, at time of enrollment. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Agrees to the collection of biospecimens (eg, nasopharyngeal \[NP\] swabs) and venous blood per protocol. 4. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 5. Ability to swallow a capsule. 6. Temperature \< 38°C. 7. Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease. 8. Agreement to practice effective contraception for female subjects of childbearing potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
Exclusion criteria
1. Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past. 2. Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential. 3. Live in a nursing home or long-term care facility. 4. Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma. 5. Pulmonary fibrosis. 6. Current or former smoker. 7. Bone marrow or organ transplantation. 8. Obesity (defined as body mass index \[BMI\] of 30 kg/m2 or higher). 9. Diabetes. 10. Chronic kidney disease. 11. Liver disease. 12. Sickle cell disease. 13. Thalassemia. 14. Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients. 15. Any disease associated with acute fever, or any infection. 16. Self-reported history of severe acute respiratory syndrome (SARS). 17. History of hepatitis B or hepatitis C. 18. HIV or other acquired or hereditary immunodeficiency. 19. Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc. 20. Cerebrovascular disease. 21. Cystic fibrosis. 22. Neurologic conditions, such as dementia. 23. Hereditary or acquired angioneurotic edema. 24. Urticaria in the last 12 months. 25. No spleen or functional asplenia. 26. Platelet disorder or other bleeding disorder that may cause injection contraindication. 27. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness within 3 months before administration of study vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.) 28. Prior administration of blood products in last 4 months. 29. Prior administration of other research medicines in last 1 month. 30. Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination. 31. Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination. 32. Current treatment with investigational, authorized, or approved agents for prophylaxis of COVID-19. 33. Have a household contact that has been diagnosed with COVID-19. 34. Current anti-tuberculosis prophylaxis or therapy. 35. Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ). 36. According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent. 37. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Solicited Local Reactogenicity AEs | 1 week post final vaccine administration | Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine |
| Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs | 1 week post final vaccine administration | Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration |
| Incidence of Unsolicited AEs | 1 week post final vaccine administration | Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration |
| Incidence of Unsolicited Treatment-Related AEs | 1 week post final vaccine administration | Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration |
| Incidence of MAAEs | 6 Months post final vaccine administration | Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration |
| Incidence of Serious AEs | 6 Months Post Final Vaccine | Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain. | 4 |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain. | 10 |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain. | 10 |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
hAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
hAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain. | 4 |
| Total | 28 |
Baseline characteristics
| Characteristic | Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.2 years STANDARD_DEVIATION 8.18 | 39.2 years STANDARD_DEVIATION 9.67 | 42.2 years STANDARD_DEVIATION 10.75 | 44.5 years STANDARD_DEVIATION 5.8 | 41.8 years STANDARD_DEVIATION 9.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 9 Participants | 9 Participants | 4 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Healthy volunteers with a negative for SARS-CoV-2 test | 4 Participants | 10 Participants | 10 Participants | 4 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 10 Participants | 5 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 5 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 3 / 4 | 8 / 10 | 0 / 10 | 3 / 4 | 4 / 4 | 9 / 10 | 7 / 10 | 4 / 4 | 2 / 4 | 5 / 10 | 5 / 10 | 3 / 4 | 1 / 4 | 4 / 10 | 4 / 10 | 3 / 4 | 2 / 4 | 5 / 10 | 5 / 10 | 3 / 4 | 1 / 4 | 4 / 10 | 4 / 10 | 3 / 4 | 0 / 4 | 3 / 10 | 4 / 10 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 1 / 10 | 1 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 | 0 / 4 | 0 / 10 | 0 / 10 | 0 / 4 |
Outcome results
Primary
Incidence of MAAEs
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Time frame: 6 Months post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of MAAEs | 0 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of MAAEs | 3 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of MAAEs | 4 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of MAAEs | 0 Participants |
Primary
Incidence of Serious AEs
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Time frame: 6 Months Post Final Vaccine
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Serious AEs | 0 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Serious AEs | 1 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Serious AEs | 1 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Serious AEs | 0 Participants |
Primary
Incidence of Solicited Local Reactogenicity AEs
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Time frame: 1 week post final vaccine administration
Population: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Solicited Local Reactogenicity AEs | 3 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Solicited Local Reactogenicity AEs | 8 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Solicited Local Reactogenicity AEs | 0 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Solicited Local Reactogenicity AEs | 3 Participants |
Primary
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
Population: Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs | 4 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs | 9 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs | 7 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs | 4 Participants |
Primary
Incidence of Unsolicited AEs
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Time frame: 30 days post final vaccine
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 2 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 5 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 5 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 3 Participants |
Primary
Incidence of Unsolicited AEs
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 2 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 5 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 5 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited AEs | 3 Participants |
Primary
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Time frame: 1 week post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 1 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 4 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 4 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 3 Participants |
Primary
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Time frame: 30 Days Post Final
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 1 Participants |
| Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 4 Participants |
| Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 4 Participants |
| Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule) | Incidence of Unsolicited Treatment-Related AEs | 3 Participants |