COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Ge... | NCT04732468 | Trialant
NCT04732468
Sponsor
ImmunityBio, Inc.
Status
Terminated
Last Update Posted
Oct 15, 2024Actual
Enrollment
28Actual
Phase
Phase 1
Conditions
Covid19
Interventions
hAd5-S-Fusion+N-ETSD (Suspension for injection)
hAd5-SFusion+ N-ETSD (Oral capsule)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04732468
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
COVID-4.005
Secondary IDs
Not provided
Brief Title
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
Official Title
Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers
Acronym
Not provided
Organization
ImmunityBio, Inc.INDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early due to low enrollment.
Expanded Access Info
No
Start Date
Feb 24, 2021Actual
Primary Completion Date
Jul 11, 2022Actual
Completion Date
Jan 9, 2023Actual
First Submitted Date
Jan 27, 2021
First Submission Date that Met QC Criteria
Jan 28, 2021
First Posted Date
Feb 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2024
Results First Submitted that Met QC Criteria
Oct 10, 2024
Results First Posted Date
Oct 15, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 10, 2024
Last Update Posted Date
Oct 15, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ImmunityBio, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Covid19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
28Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
Experimental
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).
Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
Experimental
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).
Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)
Experimental
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)
Experimental
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).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
hAd5-S-Fusion+N-ETSD (Suspension for injection)
Biological
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Solicited Local Reactogenicity AEs
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
1 week post final vaccine administration
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
1 week post final vaccine administration
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
1 week post final vaccine administration
Incidence of Unsolicited AEs
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
30 days post final vaccine
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
30 Days Post Final
Incidence of MAAEs
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Ability to swallow a capsule.
Temperature < 38°C.
Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
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:
Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
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.
Live in a nursing home or long-term care facility.
Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
Pulmonary fibrosis.
Current or former smoker.
Bone marrow or organ transplantation.
Obesity (defined as body mass index [BMI] of 30 kg/m2 or higher).
Diabetes.
Chronic kidney disease.
Liver disease.
Sickle cell disease.
Thalassemia.
Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients.
Any disease associated with acute fever, or any infection.
Self-reported history of severe acute respiratory syndrome (SARS).
History of hepatitis B or hepatitis C.
HIV or other acquired or hereditary immunodeficiency.
Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.
Cerebrovascular disease.
Cystic fibrosis.
Neurologic conditions, such as dementia.
Hereditary or acquired angioneurotic edema.
Urticaria in the last 12 months.
No spleen or functional asplenia.
Platelet disorder or other bleeding disorder that may cause injection contraindication.
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.)
Prior administration of blood products in last 4 months.
Prior administration of other research medicines in last 1 month.
Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination.
Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination.
Current treatment with investigational, authorized, or approved agents for prophylaxis of COVID-19.
Have a household contact that has been diagnosed with COVID-19.
Current anti-tuberculosis prophylaxis or therapy.
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).
According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Chan Soon - Shiong Institute for Medicine
El Segundo
California
90245
United States
Hoag Memorial Hospital Presbyterian
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 31, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
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 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)
hAd5-SFusion+ N-ETSD (Oral capsule)
Drug
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.
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)
6 Months post final vaccine administration
Incidence of Serious AEs
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
6 Months Post Final Vaccine
Newport Beach
California
92663
United States
FG001
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.
FG002
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.
FG003
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) were 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.
FG0004 subjects
FG00110 subjects
FG00210 subjects
FG0034 subjects
COMPLETED
FG0001 subjects
FG00110 subjects
FG00210 subjects
FG0034 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00110
BG00210
BG0034
BG00428
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.2± 8.18
BG00139.2± 9.67
BG00242.2± 10.75
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Healthy volunteers with a negative for SARS-CoV-2 test
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0004
BG00110
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Incidence of Solicited Local Reactogenicity AEs
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
Posted
Count of Participants
Participants
1 week post final vaccine administration
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0018
OG0020
OG003
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
Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)
Posted
Count of Participants
Participants
1 week post final vaccine administration
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of Unsolicited AEs
Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration
Posted
Count of Participants
Participants
1 week post final vaccine administration
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
Posted
Count of Participants
Participants
1 week post final vaccine administration
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of Unsolicited AEs
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Posted
Count of Participants
Participants
30 days post final vaccine
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of Unsolicited Treatment-Related AEs
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
Posted
Count of Participants
Participants
30 Days Post Final
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of MAAEs
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Posted
Count of Participants
Participants
6 Months post final vaccine administration
ID
Title
Description
OG000
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.
OG001
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.
Primary
Incidence of Serious AEs
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Posted
Count of Participants
Participants
6 Months Post Final Vaccine
ID
Title
Description
OG000
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.
OG001
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.
Time Frame
Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.
Description
For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1:Cohort 1
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
4
0
4
3
4
EG001
Group 1: Cohort 2
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
10
1
10
8
10
EG002
Group 1:Cohort 3
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
10
1
10
0
10
EG003
Group 1:Cohort 4
Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
4
0
4
3
4
EG004
Group 2: Cohort 1
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
4
0
4
4
4
EG005
Group 2: Cohort 2
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
10
0
10
9
10
EG006
Group 2: Cohort 3
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
10
0
10
7
10
EG007
Group 2: Cohort 4
Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
0
4
0
4
4
4
EG008
Group 3:Cohort 1
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
0
4
0
4
2
4
EG009
Group 3: Cohort 2
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
5
10
EG010
Group 3: Cohort 3
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
5
10
EG011
Group 3: Cohort 4
Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration
0
4
0
4
3
4
EG012
Group 4: Cohort 1
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
0
4
0
4
1
4
EG013
Group 4: Cohort 2
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
4
10
EG014
Group 4: Cohort 3
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
4
10
EG015
Group 4: Cohort 4
Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration
0
4
0
4
3
4
EG016
Group 5: Cohort 1
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
4
0
4
2
4
EG017
Group 5:Cohort 2
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
5
10
EG018
Group 5: Cohort 3
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
5
10
EG019
Group 5: Cohort 4
Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
4
0
4
3
4
EG020
Group 6: Cohort 1
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
0
4
0
4
1
4
EG021
Group 6: Cohort 2
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
4
10
EG022
Group 6: Cohort 3
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
4
10
EG023
Group 6: Cohort 4
Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration
0
4
0
4
3
4
EG024
Group 7: Cohort 1
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
4
0
4
0
4
EG025
Group 7: Cohort 2
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
3
10
EG026
Group 7:Cohort 3
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
4
10
EG027
Group 7: Cohort 4
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
4
0
4
0
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diverticulitis
Infections and infestations
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG0030 affected4 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected10 at risk
EG0100 affected10 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected10 at risk
EG0140 affected10 at risk
EG0150 affected4 at risk
EG0160 affected4 at risk
EG0170 affected10 at risk
EG0180 affected10 at risk
EG0190 affected4 at risk
EG0200 affected4 at risk
EG0210 affected10 at risk
EG0220 affected10 at risk
EG0230 affected4 at risk
EG0244 at risk
EG02510 at risk
EG02610 at risk
EG0274 at risk
Radius fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
Systematic Assessment
EG0003 affected4 at risk
EG0016 affected10 at risk
EG0020 affected10 at risk
EG0033 affected4 at risk
EG0040 affected4 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected4 at risk
EG0080 affected4 at risk
EG0090 affected10 at risk
EG0100 affected10 at risk
EG0110 affected4 at risk
EG0120 affected4 at risk
EG0130 affected10 at risk
EG0140 affected10 at risk
EG0150 affected4 at risk
EG0160 affected4 at risk
EG0170 affected10 at risk
EG0180 affected10 at risk
EG0190 affected4 at risk
EG0200 affected4 at risk
EG0210 affected10 at risk
EG0220 affected10 at risk
EG0230 affected4 at risk
EG0244 at risk
EG0250 affected10 at risk
EG0260 affected10 at risk
EG0270 affected4 at risk
Injection site erythema
General disorders
Systematic Assessment
EG0003 affected4 at risk
EG0013 affected10 at risk
EG0020 affected10 at risk
EG003
Injection site pruritus
General disorders
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected10 at risk
EG0020 affected10 at risk
EG003
Injection site reaction
General disorders
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected10 at risk
EG0020 affected10 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nausea
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Feeling abnormal
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Feeling hot
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Injection site induration
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Swelling Face
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vessel puncture site pain
General disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypoaesthesia
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Eye discharge
Eye disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ocular discomfort
Eye disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hot flush
Vascular disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Throat tightness
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ehlers-Danlos syndrome
Congenital, familial and genetic disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Gastric polyps
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Diverticulitis
Infections and infestations
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
The study was terminated early due to low enrollment.
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0004
OG0019
OG0027
OG0034
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0025
OG0033
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0024
OG0033
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0025
OG0033
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0024
OG0033
OG002
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.
OG003
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.
Units
Counts
Participants
OG0004
OG00110
OG00210
OG0034
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013
OG0024
OG0030
OG002
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.
OG003
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.