Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults
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ClinicalTrials.gov Identifier: NCT04563702 |
Recruitment Status :
Completed
First Posted : September 24, 2020
Last Update Posted : April 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Biological: VXA-CoV2-1 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Open-label, repeat dose, dose ranging |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers |
Actual Study Start Date : | September 21, 2020 |
Actual Primary Completion Date : | October 10, 2021 |
Actual Study Completion Date : | October 10, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Dose VXA-CoV2-1
Low dose (1E10 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1. A subset will also receive a second dose at Day 29
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Biological: VXA-CoV2-1
non replicating Ad5 adjuvanted oral tableted vaccine |
Experimental: High Dose
High Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1
|
Biological: VXA-CoV2-1
non replicating Ad5 adjuvanted oral tableted vaccine |
- Frequency of solicited symptoms of reactogenicity [ Time Frame: Day 1 through Day 8 post each immunization ]Subject reported symptoms of local and systemic reactogenicity
- Grade of solicited symptoms of reactogenicity [ Time Frame: Day 1 through Day 8 post each immunization ]Subject reported symptoms of local and systemic reactogenicity
- Frequency of unsolicited adverse events [ Time Frame: Day 1 through Day 29 post each immunization ]Any adverse events observed or reported following vaccination
- Grade of unsolicited adverse events [ Time Frame: Day 1 through Day 29 post each immunization ]Any adverse events observed or reported following vaccination
- Frequency of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 390 ]Any adverse events reported following vaccination meeting definition of serious
- Frequency of medically-attended adverse events (MAAEs) [ Time Frame: Day 1 through Day 390 ]Any adverse events reported following vaccination meeting definition of serious
- SARS-CoV-2 specific IgG/IgA [ Time Frame: Day 1 through Day 390 ]SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay (ELISA)
- Neutralizing antibody titers to SARS-CoV-2 [ Time Frame: Day 1 through Day 390 ]serum based assay of Ab titers
- Antigen-specific IgG/IgA antibody secreting (ASCs) [ Time Frame: Day 1 through Day 44 ]ASCs by ELISpot
- Th1/Th2 polarization [ Time Frame: Day 1 through Day 44 ]Flow Cytometry

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 54 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female between the ages of 18 to 54 years, inclusive.
- Negative for SARS-CoV-2 infection at the time of screening
- In generally good health, without significant medical illness
- Demonstrates comprehension of the protocol procedures and is able to provide written informed consent.
- Available for all planned visits and willing to complete all protocol defined procedures and assessments
- Body mass index between 17 and 30 kg/m2 at screening.
- Female subjects must have a negative pregnancy test at screening and before each vaccination and fulfill an acceptable method of birth control (per protocol)
Exclusion Criteria:
- Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
- Is in a current occupation with high risk of exposure to SARS-CoV-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 CDC's guidance
- Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
- 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.
- Positive HIV, HBsAg or HCV tests at the screening visit.
- Stool sample with occult blood at screening.
- Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 7 days before vaccination
- Use of antibiotics, proton pump inhibitors, H2 blockers or antacids or medications known to affect the immune function within 7 to 14 days before vaccination
- Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 7 days before vaccination
- Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness
- History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug screen for drugs of abuse at screening
- History of hypersensitivity or allergic reaction to any component of the investigational vaccine
- Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a subject participating in the trial, would render the subject unable to comply with the protocol or would interfere with the evaluation of the study endpoints.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563702
United States, California | |
WCCT | |
Cypress, California, United States, 90630 |
Responsible Party: | Vaxart |
ClinicalTrials.gov Identifier: | NCT04563702 |
Other Study ID Numbers: |
VXA-COV2-101 |
First Posted: | September 24, 2020 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | A plan on how to share individual subject's outcomes will be defined within the next few months. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
VXA-C0V2-1 Vaxart oral vaccine tablet vaccine |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |