A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine | NCT05067933 | Trialant
NCT05067933
Sponsor
Vaxart
Status
Terminated
Last Update Posted
Apr 13, 2025Actual
Enrollment
66Actual
Phase
Phase 2
Conditions
COVID-19
Interventions
VXA-CoV2-1.1-S
Placebo Tablets
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05067933
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VXA-COV2-201
Secondary IDs
Not provided
Brief Title
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Official Title
A Phase 2, Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety, Immunogenicity and Efficacy of an Adenoviral-Vector Based Vaccine Expressing Severe Acute Respiratory Syndrome (SARS-CoV-2) and dsRNA Adjuvant Administered Orally
Acronym
Not provided
Organization
VaxartINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study drug was no longer available.
Expanded Access Info
No
Start Date
Oct 22, 2021Actual
Primary Completion Date
Jun 10, 2022Actual
Completion Date
May 9, 2023Actual
First Submitted Date
Sep 16, 2021
First Submission Date that Met QC Criteria
Oct 1, 2021
First Posted Date
Oct 5, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 24, 2025
Results First Submitted that Met QC Criteria
Mar 18, 2025
Results First Posted Date
Apr 13, 2025Actual
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
Mar 18, 2025
Last Update Posted Date
Apr 13, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
VaxartINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.
Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.
Detailed Description
Part 1: This is an open-label, dose-ranging phase of the study to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1.1-S) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers, either naïve or prior vaccinated with an mRNA COVID-19 vaccine, aged 18 - 55 yrs old, and then 56 - 75 yrs old, will be enrolled into the study in 8 subgroups. Participants will receive either a low or a high dose of an oral tableted vaccine at Days 1 and Day 29. The total study period will last ~ 2 months during the active phase, with a total 12 month safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the study active and follow-up periods. Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study follow-up period. An independent data monitoring committee (IDMC) will provide safety oversight through the duration of the trial. Safety and immunogenicity data will inform on the dose selection for Part 2.
Part 2: This will be a placebo-controlled phase with the vaccine dose level selected from Part 1. Subjects will receive two doses of vaccine or placebo at Days 1 and 29. Subjects will be followed as in Part 1 for safety and immunogenicity. They will also be followed for 6 months for efficacy.
Conditions Module
Conditions
COVID-19
Keywords
oral vaccine
SARS-CoV-2
tablet vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
66Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Cohort 1a (Naïve, low dose, young adult)
Experimental
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 1b (Naïve, high dose, young adult)
Experimental
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 1c (Naïve, low dose, older adult)
Experimental
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 1d (Naïve, high dose, older adult)
Experimental
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 2a (Prior vaccinated, low dose, young adult)
Experimental
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine
Number of Participants Who Experienced a Solicited Symptom of Reactogenicity
Solicited symptoms of reactogenicity were predefined systemic signs and symptoms of reactogenicity for which the participant was specifically questioned, and which were noted by the participant in their daily Solicited Symptom Diary for 7 days after each vaccination, including:
fever (any temperature 100°F or higher)
headache
myalgia (muscle pain)
abdominal pain
anorexia (defined and not eating)
nausea
vomiting
diarrhea
malaise/fatigue
Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Severity of Solicited Symptoms of Reactogenicity
Solicited symptoms of reactogenicity were predefined systemic signs and symptoms of reactogenicity for which the participant was specifically questioned, and which were noted by the participant in their daily Solicited Symptom Diary for 7 days after each vaccination, including:
fever (any temperature 100°F or higher)
headache
myalgia (muscle pain)
abdominal pain
anorexia (defined and not eating)
nausea
vomiting
diarrhea
malaise/fatigue
Participants were instructed to rate solicited symptoms of reactogenicity that were collected in their Solicited Symptom Diary with the below grades, against pre-defined criteria as noted in the protocol:
Grade 1 - Mild
Grade 2 - Moderate
Grade 3 - Severe
Grade 4 - Life Threatening
Participants with multiple solicited symptoms were only counted once, the highest severity of which was used.
Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
Number of Participants Who Experienced an Unsolicited Treatment-emergent Adverse Event (TEAE) During the Active Treatment Period
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, occurring after first dose of study drug.
A serious TEAE was any TEAE that met any of the following criteria:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent or significant disability/incapacity.
Was a congenital anomaly/birth defect.
Was a suspected transmission of any infectious agent via a medicinal product.
Was a significant medical event, as judged by the investigator.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a MAAE During the Safety Follow-up Period
MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. NOCI and AESIs were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
18 - 75 years of age (inclusive) at the time of signing the Informed Consent Form (ICF).
Cohort 1 ONLY - Naive of any prior vaccination for the prevention of COVID-19 (tested using a rapid antibody test) at screening and within 7 days prior to the enrollment (Day 1).
Cohort 2 ONLY - Have received prior immunizations (both doses) with an EUA or FDA approved mRNA vaccine for the prevention of COVID-19, at least 6 months prior to enrollment (Day 1).
In stable and good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratory tests as determined by the Investigator.
Safety laboratory values1 within the following range criteria at screening:
Laboratory values within normal range or grade 1 outside the range of normal with no clinical significance (NCS) for the following analytes:, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin, blood urea nitrogen (BUN), creatinine, glucose, potassium, and sodium
Laboratory values within normal range for platelet counts2 and the following coagulation tests: PT/INR, aPTT and fibrinogen
Body mass index (BMI) between 17 and 32 kg/m2 at screening.
Capable of providing signed informed consent.
Available for all planned visits and phone calls, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per vaccine dose).
Gender and Reproductive Considerations
Male or female participants. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Refer to Appendix 4 (Section 9.4).
Female participants must not be breastfeeding and must have a negative pregnancy test at screening and before each vaccination and fulfill one of the following criteria:
At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause).
Women under 60 years will need to verify post-menopausal status via a follicle-stimulating hormone (FSH) test if another option to prevent potential pregnancy will not be utilized for 30 days prior to baseline vaccination and until 60 days after the last vaccination.
Surgically sterile
Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to initial vaccination and until 60 days after the last vaccination.
A reliable form of contraception must be approved by the Investigator (e.g., double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches).
Not be sexually active (abstinent) or be in a relationship with partner who is sterile (must be discussed with site staff and documented).
Exclusion Criteria Medical Conditions
Clinically significant acute illness within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam) (assessment may be repeated during screening period).
Current or known previous infection with SARS-CoV-2 or receipt of any therapeutic for the prevention or treatment of COVID-19, Middle East Respiratory Syndrome (MERS), or severe acute respiratory syndrome (SARS). [EUA or FDA approved mRNA vaccines for the prevention of SARS-CoV-2 infection taken at least 6 months prior to enrollment are permitted in Cohort 2]
Individuals with the following underlying medical conditions who are at higher risk (or might be at higher risk) of severe illness from COVID-19 per the guidance from the Centers for Disease Control and Prevention (CDC):
Cancer, including history of cancer or treatment within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
Chronic kidney disease
Chronic obstructive pulmonary disease (COPD)
Immunocompromised state from solid organ transplant, or other medical condition
Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
Sickle cell disease
Uncontrolled type 2 diabetes mellitus
Asthma (moderate to severe)
Cerebrovascular disease
Cystic fibrosis
Uncontrolled hypertension or high blood pressure
Immunocompromised state from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines
Neurologic conditions, such as dementia
Liver disease
Pregnancy or breast feeding
Pulmonary fibrosis
Chronic smoking (≥ 1 cigarette per day)
Thalassemia
Type 1 diabetes mellitus
Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
Any condition that resulted in the absence or removal of the spleen.
Any other condition that in the clinical judgment of the Investigator would jeopardize the safety or rights of a participant participating in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints.
Diagnostic Assessments
Temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned study vaccination (assessment may be repeated during screening period).
Positive HIV, Hepatitis B surface antigen (HBsAg) or HCV tests at the screening visit.
History of gastrointestinal bleeding (e.g. melena or hematochezia) Prior/Concurrent Therapy Note: The Active Period is defined as the time period from Day 1 through Week 8, or 4 weeks post last vaccination.
Receipt of a licensed influenza vaccine within 14 days prior to baseline vaccination or another licensed vaccine within 28 days prior to baseline vaccination, or planned administration during the study active period.
Use of antiviral medications , including anti-retrovirals within 1 week before vaccination or planned use during the active study period.
Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 1 week before vaccination or planned use during the active study period.
Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 14 days before vaccination or planned use during the active study period.
Daily use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 1 week before vaccination or planned use during the active study period.
Positive urine drug screen for drugs of abuse at screening (except for previous marijuana use); concurrent or planned use of marijuana during the active study period.
Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination, or planned use within the duration of the study.
Other Exclusions
Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
Any significant hospitalization within the last year which in the opinion of the Investigator or Sponsor could interfere with study participation.
History of drug, alcohol or chemical abuse within 1 year of screening.
History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.
Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
Family or personal history of bleeding or thrombosis
History of heparin-related thrombotic events, and/or receiving heparin treatments
History of autoimmune or inflammatory disease
Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:
Recent surgery other than removal/biopsy of cutaneous lesions
Immobility (confined to bed or wheelchair for 3 or more successive days)
Head trauma with loss of consciousness or documented brain injury
Receipt of anticoagulants for prophylaxis of thrombosis
Recent clinically significant infection
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
James Cummings, MD
Vaxart, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ark Clinical Research
Long Beach
California
90806
United States
AMR Wichita East
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
Not provided
Recruitment Details
A total of 66 participants were enrolled at 5 sites in the United States between 22 October 2021 and 09 May 2023 (follow-up period cut-off) in Part 1 of the study.
Vaxart decided not to conduct Part 2 of this study, so results for Part 2 were not included in this summary.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1a: Vaccine Naïve, 18-55 Years, Low-dose
Healthy, vaccine naïve participants aged between 18 and 55 years received VXA-CoV2-1.1-S at a dose of 1 x 10^10 infectious units (IU) ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
FG001
Cohort 1b: Vaccine Naïve, 18-55 Years, High-dose
Healthy, vaccine naïve participants aged between 18 and 55 years received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
FG002
Cohort 1c: Vaccine Naïve, 56-75 Years, Low-dose
Healthy, vaccine naïve participants aged between 56 and 75 years received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
FG003
Cohort 2a: Prior Vaccinated, 18-55 Years, Low-dose
Healthy, prior vaccinated participants aged between 18 and 55 years received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
FG004
Cohort 2b: Prior Vaccinated, 18-55 Years, High-dose
Healthy, prior vaccinated participants aged between 18 and 55 years received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
FG005
Cohort 2c: Prior Vaccinated, 56-75 Years, Low-dose
Healthy, prior vaccinated participants aged between 56 and 75 years received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00012 subjects
FG0019 subjects
FG0028 subjects
FG00313 subjects
FG00412 subjects
FG00512 subjects
Received First Dose of VXA-CoV2-1.1-S
FG00012 subjects
FG0019 subjects
FG0028 subjects
FG00313 subjects
Received Both Doses of VXA-CoV2-1.1-S
FG00011 subjects
FG0019 subjects
FG0028 subjects
FG00313 subjects
Entered Safety Follow-up Period
FG00010 subjects
FG0019 subjects
FG0028 subjects
FG00312 subjects
FG004
COMPLETED
FG0008 subjects
FG0018 subjects
FG0027 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety Population: Included all randomized participants who received at least one dose of the study drug and were analyzed in the treatment group corresponding to actual study drug received. Participant flow is presented per cohort due to sequential enrollment. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
BG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
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
Number of Participants Who Experienced a Solicited Symptom of Reactogenicity
Solicited symptoms of reactogenicity were predefined systemic signs and symptoms of reactogenicity for which the participant was specifically questioned, and which were noted by the participant in their daily Solicited Symptom Diary for 7 days after each vaccination, including:
fever (any temperature 100°F or higher)
headache
myalgia (muscle pain)
abdominal pain
anorexia (defined and not eating)
nausea
vomiting
diarrhea
malaise/fatigue
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants with evaluable data at each dosing time point were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
ID
Title
Description
OG000
Adverse Events Module
Frequency Threshold
4
Time Frame
Active Study Period: Day 1 to Day 57; Safety Follow-up Period: Last-dose to up to 12 months post-last dose
Description
Safety Population: Included all randomized participants who received at least one dose of the study drug and were analyzed in the treatment group corresponding to actual study drug received. During the safety follow-up period, only SAEs and MAAEs were collected.
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
Active Study Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hospitalization
Surgical and medical procedures
MedDRA (24.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA (24.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Vaxart decided not to conduct Part 2 of this study, so results for Part 2 were not included in this summary.
Open-label dose and age escalation lead in phase in naive and prior vaccinated subjects, followed by a multi-center, placebo-controlled efficacy phase.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Double-Blind, Randomized (Part 2)
Who Masked
ParticipantCare ProviderInvestigator
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 2b (Prior vaccinated, high dose, young adult)
Experimental
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 2c (Prior vaccinated, low dose, older adult)
Experimental
1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine
Drug: VXA-CoV2-1.1-S
Part 1 Cohort 2d (Prior vaccinated, high dose, older adult)
Experimental
1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine
Drug: VXA-CoV2-1.1-S
Part 2 Healthy Adults: Active vaccine
Experimental
Repeat dose vaccinations with VXA-CoV2-1.1-S at dose selected from Part 1 in healthy male and female adult volunteers 18 to 75 years old
Drug: VXA-CoV2-1.1-S
Part 2 Healthy Adults: Placebo control
Placebo Comparator
Repeat dose administration with matching placebo tablets in healthy male and female adult volunteers 18 to 75 years old
Other: Placebo Tablets
Part 1 Cohort 1b (Naïve, high dose, young adult)
Part 1 Cohort 1c (Naïve, low dose, older adult)
Part 1 Cohort 1d (Naïve, high dose, older adult)
Part 1 Cohort 2a (Prior vaccinated, low dose, young adult)
Part 1 Cohort 2b (Prior vaccinated, high dose, young adult)
Part 1 Cohort 2c (Prior vaccinated, low dose, older adult)
Part 1 Cohort 2d (Prior vaccinated, high dose, older adult)
Part 2 Healthy Adults: Active vaccine
Oral Tableted Ad5 COVID-19 Vaccine
Placebo Tablets
Other
Placebo tablets matching the active vaccine tablets
Part 2 Healthy Adults: Placebo control
Day 1 to Day 57
Severity of Unsolicited TEAEs During the Active Treatment Period
All unsolicited TEAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple TEAEs during the active treatment period were only counted once, the highest severity of which was used.
Day 1 to Day 57
Number of Participants Who Experienced a Medically Attended Adverse Event (MAAE) During the Active Treatment Period
MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic illness/diseases (NOCI) and adverse events of special interest (AESIs) were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.
Day 1 to Day 57
Severity of MAAEs During the Active Treatment Period
All MAAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple MAAEs during the active treatment period were only counted once, the highest severity of which was used.
Day 1 to Day 57
From last dose up to 12 months post-last dose
Severity of MAAEs During the Safety Follow-up Period
All MAAEs during the safety follow-up period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple MAAEs during the safety follow-up period were only counted once, the highest severity of which was used.
From last dose up to 12 months post-last dose
Number of Participants Who Experienced a Serious TEAE During the Safety Follow-up Period
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, occurring after first dose of study drug.
A serious TEAE was any TEAE that met any of the following criteria:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent or significant disability/incapacity.
Was a congenital anomaly/birth defect.
Was a suspected transmission of any infectious agent via a medicinal product.
Was a significant medical event, as judged by the investigator.
From last dose up to 12 months post-last dose
Severity of Serious TEAEs During the Safety Follow-up Period
All serious TEAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple serious TEAEs during the active treatment period were only counted once, the highest severity of which was used.
From last-dose up to 12 months post-last dose
Levels of SARS-CoV2-specific Immunoglobulin G Spike (IgG-S) Antibodies by Mesoscale Discovery (MSD) Assay
SARS-CoV2-specific IgG-S antibody levels were measured on specific timepoints via MSD assay. For results below the lower limit of quantification (LLOQ), the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the upper limit of quantification (ULOQ), the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific Immunoglobulin G Nucleocapsid (IgG-N) Antibodies by MSD Assay
SARS-CoV2-specific IgG-N antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific Immunoglobulin G Receptor-binding Domain (IgG-RBD) Antibodies by MSD Assay
SARS-CoV2-specific IgG-RBD antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific Immunoglobulin A Spike (IgA-S) Antibodies by MSD Assay
SARS-CoV2-specific IgA-S antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific Immunoglobulin A Nucleocapsid (IgA-N) Antibodies by MSD Assay
SARS-CoV2-specific IgA-N antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific Immunoglobulin A Receptor-binding Domain (IgA-RBD) Antibodies by MSD Assay
SARS-CoV2-specific IgA-RBD antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of Neutralizing Serum Antibody Titers to SARS-CoV-2
Neutralizing Serum Antibody Titers to SARS-CoV-2 were measured on specific timepoints via qualified pseudovirus assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Mean Percentage of Cluster of Differentiation 8 (CD8) T-cells Making Tumor Necrosis Factor (TNF) Alpha+ Spike (S) as Measured by Intracellular Cytokine Cytometry (ICC)
Mean Percentage of CD8 T-cells making TNF alpha+S were measured on specific timepoints via ICC. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 8, Day 29 and Day 36
Mean Percentage of CD8 T-cells Making Interferon (IFN) Gamma+S as Measured by ICC
Mean Percentage of CD8 T-cells making IFN gamma+S were measured on specific timepoints via ICC. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 8, Day 29 and Day 36
Levels of SARS-CoV2-specific IgA-S Antibodies in Nasal Swabs
SARS-CoV2-specific IgA-S antibody levels in nasal swabs were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Levels of SARS-CoV2-specific IgA-S Antibodies in Saliva Swabs
SARS-CoV2-specific IgA-S antibody levels in saliva swabs were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Day 1, Day 29 and Day 57
Wichita
Kansas
64114
United States
Velocity Clinical Research, Inc,
Cleveland
Ohio
44122
United States
AMR Knoxville
Knoxville
Tennessee
37909
United States
FG004
12 subjects
FG00512 subjects
FG004
12 subjects
FG00512 subjects
12 subjects
FG00512 subjects
11 subjects
FG00512 subjects
1 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG0050 subjects
Miscellaneous
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
BG002
Total
Total of all reporting groups
45
BG00121
BG00266
Participants
Title
Denominators
Categories
18 - 55 years
Title
Measurements
BG00025
BG00121
BG00246
56 - 75 years
Title
Measurements
BG00020
BG0010
BG00220
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00110
BG00230
Male
BG00025
BG00111
BG00236
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG0015
BG00215
Not Hispanic or Latino
BG00035
BG00116
BG00251
Unknown or Not Reported
BG0000
BG0010
BG0020
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00029
BG00110
BG00239
Black or African American
BG0006
BG0015
BG00211
Asian
BG0006
BG0014
BG00210
Other
BG0002
BG0011
BG0023
Multiple
BG0002
BG0011
BG0023
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00045
OG00121
Title
Denominators
Categories
Dose 1
ParticipantsOG00045
ParticipantsOG00121
Title
Measurements
OG00016
OG00110
Dose 2
ParticipantsOG00044
ParticipantsOG00121
Title
Measurements
OG00013
OG001
Primary
Severity of Solicited Symptoms of Reactogenicity
Solicited symptoms of reactogenicity were predefined systemic signs and symptoms of reactogenicity for which the participant was specifically questioned, and which were noted by the participant in their daily Solicited Symptom Diary for 7 days after each vaccination, including:
fever (any temperature 100°F or higher)
headache
myalgia (muscle pain)
abdominal pain
anorexia (defined and not eating)
nausea
vomiting
diarrhea
malaise/fatigue
Participants were instructed to rate solicited symptoms of reactogenicity that were collected in their Solicited Symptom Diary with the below grades, against pre-defined criteria as noted in the protocol:
Grade 1 - Mild
Grade 2 - Moderate
Grade 3 - Severe
Grade 4 - Life Threatening
Participants with multiple solicited symptoms were only counted once, the highest severity of which was used.
Safety Population: Included all randomized participants who received at least one dose of the study drug and experienced a solicited symptom of reactogenicity. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received. The overall number of participants analyzed is inclusive of participants all participants with symptoms following Dose 1 and/or Dose 2.
Posted
Count of Participants
Participants
Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00023
OG00111
Title
Denominators
Categories
Dose 1
ParticipantsOG00016
ParticipantsOG00110
Title
Measurements
Grade 1 - Mild
OG00011
Primary
Number of Participants Who Experienced an Unsolicited Treatment-emergent Adverse Event (TEAE) During the Active Treatment Period
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, occurring after first dose of study drug.
A serious TEAE was any TEAE that met any of the following criteria:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent or significant disability/incapacity.
Was a congenital anomaly/birth defect.
Was a suspected transmission of any infectious agent via a medicinal product.
Was a significant medical event, as judged by the investigator.
Safety Population: Included all randomized participants who received at least one dose of the study drug. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
Day 1 to Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00045
OG00121
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00010
OG0014
Any Serious TEAE
Title
Measurements
OG000
Primary
Severity of Unsolicited TEAEs During the Active Treatment Period
All unsolicited TEAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple TEAEs during the active treatment period were only counted once, the highest severity of which was used.
Safety Population: Included all randomized participants who received at least 1 dose of study drug & experienced an unsolicited TEAE during the active treatment period. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures & Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received. The overall number of participants analyzed is inclusive of participants all participants with symptoms following Dose 1 &/or Dose 2.
Posted
Count of Participants
Participants
Day 1 to Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00010
OG0014
Title
Denominators
Categories
Any TEAE
ParticipantsOG00010
ParticipantsOG0014
Title
Measurements
Mild
OG0004
Primary
Number of Participants Who Experienced a Medically Attended Adverse Event (MAAE) During the Active Treatment Period
MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic illness/diseases (NOCI) and adverse events of special interest (AESIs) were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.
Safety Population: Included all randomized participants who received at least one dose of the study drug. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
Day 1 to Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00045
OG00121
Title
Denominators
Categories
Title
Measurements
OG0006
OG0010
Primary
Severity of MAAEs During the Active Treatment Period
All MAAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple MAAEs during the active treatment period were only counted once, the highest severity of which was used.
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants who experienced an MAAE during the active treatment period were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
Day 1 to Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG0006
OG0010
Title
Denominators
Categories
Title
Measurements
Mild
OG0002
Moderate
OG0002
Severe
OG000
Secondary
Number of Participants Who Experienced a MAAE During the Safety Follow-up Period
MAAEs were defined as TEAEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. NOCI and AESIs were collected as part of the MAAEs. As defined in the protocol, adverse events for potential immune-mediated medical conditions as well as events associated with thrombosis and thrombocytopenia were considered AESIs.
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants who entered the safety follow-up period were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
From last dose up to 12 months post-last dose
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00044
OG00121
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
Secondary
Severity of MAAEs During the Safety Follow-up Period
All MAAEs during the safety follow-up period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple MAAEs during the safety follow-up period were only counted once, the highest severity of which was used.
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants who experienced an MAAE during the safety follow-up period were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
From last dose up to 12 months post-last dose
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG0005
OG0012
Title
Denominators
Categories
Title
Measurements
Mild
OG0001
OG0010
Moderate
OG0002
Secondary
Number of Participants Who Experienced a Serious TEAE During the Safety Follow-up Period
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, occurring after first dose of study drug.
A serious TEAE was any TEAE that met any of the following criteria:
Resulted in death.
Was life-threatening.
Required inpatient hospitalization or prolongation of existing hospitalization.
Resulted in persistent or significant disability/incapacity.
Was a congenital anomaly/birth defect.
Was a suspected transmission of any infectious agent via a medicinal product.
Was a significant medical event, as judged by the investigator.
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants who entered the safety follow-up period were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
From last dose up to 12 months post-last dose
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00044
OG00121
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
Secondary
Severity of Serious TEAEs During the Safety Follow-up Period
All serious TEAEs during the active treatment period were assessed by the investigator using the below scale:
Mild: Events that required minimal or no treatment and did not interfere with the participant's daily activities.
Moderate: Events that resulted in a low level of inconvenience or concern with the therapeutic measures. Moderate events may have caused some interference with functioning.
Severe: Events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events were usually incapacitating.
Life Threatening: Any adverse drug experience that placed the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred.
Participants with multiple serious TEAEs during the active treatment period were only counted once, the highest severity of which was used.
Safety Population: Included all randomized participants who received at least one dose of the study drug. Only participants who experienced a serious TEAE during the safety follow-up period were included. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Count of Participants
Participants
From last-dose up to 12 months post-last dose
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG0003
OG0010
Title
Denominators
Categories
Title
Measurements
Mild
OG0000
Moderate
OG0000
Severe
OG000
Secondary
Levels of SARS-CoV2-specific Immunoglobulin G Spike (IgG-S) Antibodies by Mesoscale Discovery (MSD) Assay
SARS-CoV2-specific IgG-S antibody levels were measured on specific timepoints via MSD assay. For results below the lower limit of quantification (LLOQ), the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the upper limit of quantification (ULOQ), the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG0004708.7(1555.28 to 14255.88)
OG0016323.8(1721.12 to 23235.26)
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.953
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific Immunoglobulin G Nucleocapsid (IgG-N) Antibodies by MSD Assay
SARS-CoV2-specific IgG-N antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants with evaluable data at each time point who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
arbitrary units per milliliter (AU/mL)
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
ParticipantsOG00038
ParticipantsOG00119
Title
Measurements
OG000360.3(189.03 to 686.76)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.500
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific Immunoglobulin G Receptor-binding Domain (IgG-RBD) Antibodies by MSD Assay
SARS-CoV2-specific IgG-RBD antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG0002597.0(869.40 to 7757.64)
OG0012570.5(620.23 to 10653.33)
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.912
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific Immunoglobulin A Spike (IgA-S) Antibodies by MSD Assay
SARS-CoV2-specific IgA-S antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG000928.4(471.44 to 1828.24)
OG001809.8(279.42 to 2346.95)
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.678
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific Immunoglobulin A Nucleocapsid (IgA-N) Antibodies by MSD Assay
SARS-CoV2-specific IgA-N antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
ParticipantsOG00038
ParticipantsOG00119
Title
Measurements
OG000355.2(231.48 to 544.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.257
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific Immunoglobulin A Receptor-binding Domain (IgA-RBD) Antibodies by MSD Assay
SARS-CoV2-specific IgA-RBD antibody levels were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received a high dose of VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG000745.1(419.15 to 1324.62)
OG001562.7(226.59 to 1397.27)
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.748
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of Neutralizing Serum Antibody Titers to SARS-CoV-2
Neutralizing Serum Antibody Titers to SARS-CoV-2 were measured on specific timepoints via qualified pseudovirus assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG000101.2(44.16 to 231.70)
OG00181.7(23.85 to 279.97)
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.946
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Mean Percentage of Cluster of Differentiation 8 (CD8) T-cells Making Tumor Necrosis Factor (TNF) Alpha+ Spike (S) as Measured by Intracellular Cytokine Cytometry (ICC)
Mean Percentage of CD8 T-cells making TNF alpha+S were measured on specific timepoints via ICC. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Mean
Standard Deviation
percentage of CD8 T-cells
Day 1, Day 8, Day 29 and Day 36
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00030
OG00115
Title
Denominators
Categories
Day 1
ParticipantsOG00030
ParticipantsOG00115
Title
Measurements
OG0000.071± 0.1352
Secondary
Mean Percentage of CD8 T-cells Making Interferon (IFN) Gamma+S as Measured by ICC
Mean Percentage of CD8 T-cells making IFN gamma+S were measured on specific timepoints via ICC. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Mean
Standard Deviation
percentage of CD8 T-cells
Day 1, Day 8, Day 29 and Day 36
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00030
OG00115
Title
Denominators
Categories
Day 1
ParticipantsOG00030
ParticipantsOG00115
Title
Measurements
OG0000.349± 0.2933
Secondary
Levels of SARS-CoV2-specific IgA-S Antibodies in Nasal Swabs
SARS-CoV2-specific IgA-S antibody levels in nasal swabs were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Mean
Standard Deviation
AU IgA/ng Total IgA
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
ParticipantsOG00038
ParticipantsOG00119
Title
Measurements
OG0000.142± 0.3723
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.356
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
Secondary
Levels of SARS-CoV2-specific IgA-S Antibodies in Saliva Swabs
SARS-CoV2-specific IgA-S antibody levels in saliva swabs were measured on specific timepoints via MSD assay. For results below the LLOQ, the value was replaced with 1/2 the numeric portion of the original result rounded up to nearest integer. For results above the ULOQ, the value was replaced with the numeric portion of the original result.
Per Protocol Population: Included all participants who were enrolled and received at least 1 dose of study drug who were free from major protocol violations. As pre-specified in Protocol Section 8.3, Baseline Characteristics, Outcome Measures and Adverse Event analysis were summarized by vaccine group according to the study drugs they actually received.
Posted
Mean
Standard Deviation
AU IgA/ng Total IgA
Day 1, Day 29 and Day 57
ID
Title
Description
OG000
VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
OG001
VXA-CoV2-1.1-S: High Dose
Healthy participants received a high dose of VXA-CoV2-1.1-S as an oral tablet on Day 1 and Day 29 of the 57-day active study period. Participants then entered the safety follow-up period until Month 13.
Units
Counts
Participants
OG00038
OG00119
Title
Denominators
Categories
Day 1
Title
Measurements
OG0000.028± 0.0341
OG0010.062± 0.1541
Day 29
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wilcoxon rank sum tests
0.267
Other
Comparison between immunogenicity assay results between treatment groups on Day 57.
0
45
1
45
25
45
EG001
Active Study Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log as an oral tablet on Day 1 and Day 29 of the 57-day active study period.
0
21
0
21
14
21
EG002
Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^10 IU ± 0.5 Log
Healthy participants who received VXA-CoV2-1.1-S at a dose of 1 x 10^10 IU ± 0.5 log and entered the safety follow-up period until Month 13.
1
44
3
44
1
44
EG003
Safety Follow-up Period: VXA-CoV2-1.1-S: 1 x 10^11 IU ± 0.5 Log
Healthy participants who received VXA-CoV2-1.1-S at a dose of 1 x 10^11 IU ± 0.5 log and entered the safety follow-up period until Month 13.