Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04563702 |
Recruitment Status : Active, not recruiting
First Posted : September 24, 2020
Last Update Posted : April 8, 2021
|
Sponsor:
Vaxart
Information provided by (Responsible Party):
Vaxart
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
VXA-CoV2-1 is a non-replicating Ad5 vector adjuvanted oral tableted vaccine being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to evaluate the safety and immunogenicity of VXA-CoV2-1 vaccine with repeat dosing at multiple dose levels. Safety and immunogenicity will be evaluated for up to 12 months after the second dose of VXA-CoV2-1.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Biological: VXA-CoV2-1 | Phase 1 |
This is an open-label, dose-ranging trial to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers aged 18 - 54 yrs old, inclusive, will be enrolled into the study. Participants will receive an oral dose of vaccine at Days 1 and a subject will also receive a second dose at Day 29; 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.
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 |
Estimated Primary Completion Date : | May 10, 2021 |
Estimated Study Completion Date : | October 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
|
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
|
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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 |
Criteria
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.
Information from the National Library of Medicine
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
Locations
United States, California | |
WCCT | |
Cypress, California, United States, 90630 |
Sponsors and Collaborators
Vaxart
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 8, 2021 |
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 |
Keywords provided by Vaxart:
VXA-C0V2-1 Vaxart oral vaccine tablet vaccine |
Additional relevant MeSH terms:
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 |