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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:
Information provided by (Responsible Party):
Vaxart

Tracking Information
First Submitted Date  ICMJE September 21, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 21, 2020
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Open-label, repeat dose, dose ranging
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE Biological: VXA-CoV2-1
non replicating Ad5 adjuvanted oral tableted vaccine
Study Arms  ICMJE
  • 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
    Intervention: Biological: VXA-CoV2-1
  • Experimental: High Dose
    High Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1
    Intervention: Biological: VXA-CoV2-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 13, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2020)
48
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date May 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 54 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04563702
Other Study ID Numbers  ICMJE VXA-COV2-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Vaxart
Study Sponsor  ICMJE Vaxart
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vaxart
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP