Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults

• Sponsor: Vaxart (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04563702
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Open-label, repeat dose, dose rangingOpen-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: Sep 21, 2020
• Actual Primary Completion Date: Oct 10, 2021
• Actual Study Completion Date: Oct 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Frequency of solicited symptoms of reactogenicity [Day 1 through Day 8 post each immunization]

   Subject reported symptoms of local and systemic reactogenicity

2. Grade of solicited symptoms of reactogenicity [Day 1 through Day 8 post each immunization]

   Subject reported symptoms of local and systemic reactogenicity

3. Frequency of unsolicited adverse events [Day 1 through Day 29 post each immunization]

   Any adverse events observed or reported following vaccination

4. Grade of unsolicited adverse events [Day 1 through Day 29 post each immunization]

   Any adverse events observed or reported following vaccination

5. Frequency of serious adverse events (SAEs) [Day 1 through Day 390]

   Any adverse events reported following vaccination meeting definition of serious

6. Frequency of medically-attended adverse events (MAAEs) [Day 1 through Day 390]

   Any adverse events reported following vaccination meeting definition of serious

Secondary Outcome Measures

1. SARS-CoV-2 specific IgG/IgA [Day 1 through Day 390]

   SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay (ELISA)

2. Neutralizing antibody titers to SARS-CoV-2 [Day 1 through Day 390]

   serum based assay of Ab titers

3. Antigen-specific IgG/IgA antibody secreting (ASCs) [Day 1 through Day 44]

   ASCs by ELISpot

4. Th1/Th2 polarization [Day 1 through Day 44]

   Flow Cytometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 54 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female between the ages of 18 to 54 years, inclusive.

2. Negative for SARS-CoV-2 infection at the time of screening

3. In generally good health, without significant medical illness

4. Demonstrates comprehension of the protocol procedures and is able to provide written informed consent.

5. Available for all planned visits and willing to complete all protocol defined procedures and assessments

6. Body mass index between 17 and 30 kg/m2 at screening.

7. 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:

1. 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).

2. Is in a current occupation with high risk of exposure to SARS-CoV-2

3. 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

4. Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.

5. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.

6. Any condition that resulted in the absence or removal of the spleen.

7. Positive HIV, HBsAg or HCV tests at the screening visit.

8. Stool sample with occult blood at screening.

9. Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 7 days before vaccination

10. 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

11. Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 7 days before vaccination

12. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness

13. History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug screen for drugs of abuse at screening

14. History of hypersensitivity or allergic reaction to any component of the investigational vaccine

15. Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination

16. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WCCT	Cypress	California	United States	90630

Sponsors and Collaborators

• Vaxart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vaxart
• ClinicalTrials.gov Identifier: NCT04563702
• Other Study ID Numbers: VXA-COV2-101
• First Posted: Sep 24, 2020
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

No Results Posted as of Apr 28, 2022