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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563702
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Vaxart

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
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 Days 1 and 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 Days 1 and 29
Biological: VXA-CoV2-1
non replicating Ad5 adjuvanted oral tableted vaccine




Primary Outcome Measures :
  1. Frequency of solicited symptoms of reactogenicity [ Time Frame: Day 1 through Day 8 post each immunization ]
    Subject reported symptoms of local and systemic reactogenicity

  2. Grade of solicited symptoms of reactogenicity [ Time Frame: Day 1 through Day 8 post each immunization ]
    Subject reported symptoms of local and systemic reactogenicity

  3. Frequency of unsolicited adverse events [ Time Frame: Day 1 through Day 29 post each immunization ]
    Any adverse events observed or reported following vaccination

  4. Grade of unsolicited adverse events [ Time Frame: Day 1 through Day 29 post each immunization ]
    Any adverse events observed or reported following vaccination

  5. Frequency of serious adverse events (SAEs) [ Time Frame: Day 1 through Day 390 ]
    Any adverse events reported following vaccination meeting definition of serious

  6. 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 :
  1. 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)

  2. Neutralizing antibody titers to SARS-CoV-2 [ Time Frame: Day 1 through Day 390 ]
    serum based assay of Ab titers

  3. Antigen-specific IgG/IgA antibody secreting (ASCs) [ Time Frame: Day 1 through Day 44 ]
    ASCs by ELISpot

  4. 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.


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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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


Contacts
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Contact: Shaily J Garg 650-550-3534 sgarg@vaxart.com
Contact: Josefina Martinez 650-550-3504 jmartinez@vaxart.com

Locations
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United States, California
WCCT Recruiting
Cypress, California, United States, 90630
Contact: Priscilla Trejo    877-777-9228    ptinfo@wcct.com   
Contact: Tami Islam, MPH    7142520700 ext 1120    tamima.islam@wcct.com   
Principal Investigator: Youngjun Kim, MD         
Sponsors and Collaborators
Vaxart
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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: September 28, 2020
Last Verified: September 2020
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.

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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