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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 May 2021

At a glance

  • Drugs VXA CoV2-1 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Sponsors Vaxart
  • Most Recent Events

    • 03 May 2021 According to a Vaxart media release, results from this study were presented at Vaxarts key opinion leader event .
    • 03 May 2021 Results presented in a Vaxart media release.
    • 26 Apr 2021 According to a Vaxart media release, the company will host as webinar in which new data from this trial will be presented.

Trial Overview

Purpose

This phase I 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.
Participants will receive the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29.

Primary Endpoints

Frequency of solicited symptoms of reactogenicity

description: Subject reported symptoms of local and systemic reactogenicity
time_frame: Day 1 through Day 8 post each immunization

Grade of solicited symptoms of reactogenicity

description: Subject reported symptoms of local and systemic reactogenicity
time_frame: Day 1 through Day 8 post each immunization

Frequency of unsolicited adverse events

description: Any adverse events observed or reported following vaccination
time_frame: Day 1 through Day 29 post each immunization

Grade of unsolicited adverse events

description: Any adverse events observed or reported following vaccination
time_frame: Day 1 through Day 29 post each immunization

Frequency of serious adverse events (SAEs)

description: Any adverse events reported following vaccination meeting definition of serious
time_frame: Day 1 through Day 390

Frequency of medically-attended adverse events (MAAEs)

description: Any adverse events reported following vaccination meeting definition of serious
time_frame: Day 1 through Day 390

Other Endpoints

SARS-CoV-2 specific IgG/IgA

description: SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay (ELISA)
time_frame: Day 1 through Day 390

Neutralizing antibody titers to SARS-CoV-2

description: serum based assay of Ab titers
time_frame: Day 1 through Day 390

Antigen-specific IgG/IgA antibody secreting (ASCs)

description: ASCs by ELISpot
time_frame: Day 1 through Day 44

Th1/Th2 polarization

description: Flow Cytometry
time_frame: Day 1 through Day 44 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 48

    Actual: 35

  • Sex male & female
  • Age Group 18-54 years; adult

Patient 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)

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04563702 ClinicalTrials.gov: US National Institutes of Health
VXA-COV2-101 -

Organisations

  • Sponsors Vaxart
  • Affiliations Vaxart

Trial Dates

  • Initiation Dates

    Planned : 01 Sep 2020

    Actual : 21 Sep 2020

  • Primary Completion Dates

    Planned : 10 May 2021

  • End Dates

    Planned : 01 Oct 2021

Other Details

  • Design open; prospective; sequential
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
VXA CoV2-1Primary Drug Oral Tablet

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)

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)

Results

Adverse events

In a phase I trial conducted in healthy volunteers, oral administration of VXA CoV2 1 was well tolerated without showing any severe adverse events. Other mild gastrointestinal adverse events were reported in the trial [2] .

Immunogenicity

In a phase I trial conducted in healthy volunteers, oral administration of VXA CoV2 1 induced high percentage of CD8+ T cells against the viral Spike (S) protein and Nucleoprotein (N) proteins which could potentially induced cross-reactive immune response against SARS-CoV-2 viruses as well as diverse endemic coronaviruses such as 229E, NL63, HKU1, and OC43. The vaccine also induced specific IgA antibodies in the mucosa. The vaccine also induced B cell response with increase in plasmablast cells and upregulation of mucosal homing receptors as well as increase in proinflammatory Th1 cytokines. IgA antibodies were detected in serum and/or nasal swab samples in 100% of 2 dose subjects. The vaccine did not induced neutralising antibodies in serum and IgG antibodies in most participants [3] [2] .

Publications

  1. Vaxart. Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate. Media-Rel 2021;.

    Media Release
  2. Vaxart. New Data from Vaxart Oral COVID-19 Vaccine Phase I Study Suggests Broad Cross-Reactivity against Other Coronaviruses. Media-Rel 2021;.

    Media Release

Authors

Author Total Publications First Author Last Author
Vaxart 2 2 2

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Josefina Martinez
650-550-3504
jmartinez@vaxart.com
show details
Vaxart
-
Shaily J Garg
650-550-3534
sgarg@vaxart.com
show details
Vaxart
-
Tami Islam, MPH
7142520700 1120
talima.islam@wcct.com
show details
WCCT USA
Youngjun Kim, MD WCCT USA

Centres

Centre Name Location Trial Centre Country
Vaxart
-
-
WCCT Cypress, California USA

Trial History

Event Date Event Type Comment
03 May 2021 Results According to a Vaxart media release, results from this study were presented at Vaxarts key opinion leader event . Updated 10 May 2021
03 May 2021 Results Results presented in a Vaxart media release. Updated 10 May 2021
26 Apr 2021 Other trial event According to a Vaxart media release, the company will host as webinar in which new data from this trial will be presented. Updated 27 Apr 2021
22 Apr 2021 Other trial event According to a Vaxart media release, the study reached primary and secondary endpoints of safety and immunogenicity, respectively. Updated 26 Apr 2021
22 Apr 2021 Status change - completed Status changed from active, no longer recruiting to completed, according to a Vaxart Media Release. Updated 26 Apr 2021
09 Apr 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 09 Apr 2021
05 Apr 2021 Other trial event Planned primary completion date changed from 10 Dec 2020 to 10 May 2021. Updated 09 Apr 2021
03 Feb 2021 Other trial event According to a Vaxart media release, Sean Tucker, Ph.D., Vaxart's Chief Scientific Officer, will present the Phase 1 data as part of a clinical trial update at the New York Academy of Sciences Symposium "The Quest for a COVID-19 Vaccine" today at 1:15 p.m. ET. Updated 09 Feb 2021
03 Feb 2021 Results Results of preliminary data from a pooled analysis of all cohorts published in the Vaxart Media Release Updated 09 Feb 2021
26 Jan 2021 Other trial event According to a Vaxart media release, data from Phase I COVID-19 trial expected to be released next week. Updated 29 Jan 2021
13 Nov 2020 Other trial event Planned primary completion date changed from 1 Dec 2020 to 10 Dec 2020. Updated 20 Nov 2020
13 Nov 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 20 Nov 2020
13 Oct 2020 Other trial event According to a Vaxart media release, the first subject has been dosed in the study. The company expects to complete the enrollment by early November 2020. The first clinical data is expected in the next few weeks. Updated 16 Oct 2020
29 Sep 2020 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04563702) Updated 29 Sep 2020
23 Sep 2020 Status change - recruiting Status changed from planning to recruiting. Updated 29 Sep 2020
14 Sep 2020 Other trial event According to a Vaxart media release, the U.S. Food and Drug Administration (FDA) has completed its review of the Companys Investigational New Drug (IND) application for this Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate.Recruitment for this Phase 1 clinical study expected to start this month. Updated 18 Sep 2020
10 Aug 2020 Other trial event According to a Vaxart media release, the COVID-19 Investigational New Drug (IND) application has been filed with the USA Food and Drug Administration (FDA). Updated 14 Aug 2020
20 May 2020 Other trial event According to a Kindred Biosciences media release, the company has entered into an agreement with Vaxart,for the manufacture of Vaxarts oral vaccine candidate for COVID-19. KindredBio will produce the candidate vaccine bulk drug substance under Good Manufacturing Practices, and provide it to Vaxart to be formulated into a vaccine tablet to be taken by mouth instead of by needle injection. KindredBio will manufacture the vaccine for clinical trials beginning in the second half of 2020. Updated 24 May 2020
21 Apr 2020 Other trial event According to a Vaxart media release, the first stage of the collaboration between Vaxart and the Emergent BioSolutions for development services to prepare for cGMP production of an oral COVID-19 vaccine is underway and, provided Vaxart elects to proceed with cGMP manufacturing, Emergent is expected to produce bulk cGMP vaccine in time to allow the initiation of this trial. Updated 23 Apr 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020
18 Mar 2020 Other trial event According to a Vaxart media release, the company has entered into an agreement with Emergent BioSolutions Inc. whereby Emergent will deploy its contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart's experimental oral vaccine candidate for coronavirus disease (COVID-19). Updated 23 Mar 2020
18 Mar 2020 Other trial event According to a Vaxart media release, the company expects to initiate this trial early in the second half of 2020. Updated 23 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Vaxart. Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate. Media-Rel 2021;.

    Media Release
  3. Vaxart. New Data from Vaxart Oral COVID-19 Vaccine Phase I Study Suggests Broad Cross-Reactivity against Other Coronaviruses. Media-Rel 2021;.

    Media Release
  4. Vaxart. Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine and Provides Update on COVID-19 Program. Media-Rel 2020;.

    Media Release
  5. Vaxart. Vaxart to Host a Key Opinion Leader Webinar on the Importance of T-Cell Responses for COVID-19 Vaccines. Media-Rel 2021;.

    Media Release
  6. Vaxart. VAXART ANNOUNCES IT ENTERED INTO AN AGREEMENT WITH EMERGENT BIOSOLUTIONS FOR THE DEVELOPMENT AND MANUFACTURING OF ORAL CORONAVIRUS (COVID-19) VACCINE CANDIDATE. Media-Rel 2020;.

    Media Release
  7. Vaxart. Vaxart Announces Additional Preclinical COVID-19 Oral Vaccine Data and Publication. Media-Rel 2021;.

    Media Release
  8. Vaxart. Vaxart Announces Dosing First Subject in Phase 1 Clinical Trial of Its Oral Tablet COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  9. Emergent BioSolutions. EMERGENT BIOSOLUTIONS SIGNS DEVELOPMENT AND MANUFACTURING AGREEMENT WITH VAXART FOR THEIR EXPERIMENTAL ORAL VACCINE CANDIDATE FOR CORONAVIRUS DISEASE. Media-Rel 2020;.

    Media Release
  10. Vaxart. Poll: Oral Covid-19 Vaccine Pill Offers a Way to Overcome Vaccine Resistance of Millions of Americans. Media-Rel 2021;.

    Media Release
  11. Vaxart. Vaxart Announces IND Filed for COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  12. Kindred Biosciences Announces COVID-19 Vaccine Manufacturing Agreement with Vaxart. Media-Rel 2020;.

    Media Release
  13. Vaxart. Vaxart Announces Positive Pre-Clinical Data for its Oral COVID-19 Vaccine Program. Media-Rel 2020;.

    Media Release
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