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CompletedNCT04563702Updated Jun 21, 2024

Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects

A Phase 1 interventional study of VXA-CoV2-1 in Covid19, sponsored by Vaxart. Completed at 1 site in United States. Open to participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Vaxart · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Oct 2021, 4 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 54 Years
Sex
All
01

Study 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.

Read the 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.

Approximately 10 healthy male and female adult volunteers 18 to 54 years old who were enrolled in the main study will be included in a boost extension substudy for an additional 12 months from dosing for a total participation period of 24-25 months.

02

Conditions studied

  • Covid19

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Keywords

  • VXA-C0V2-1
  • Vaxart oral vaccine
  • tablet vaccine
  • VXA-C0V2-1.1
  • Boost
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 35 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Vaxart is the lead sponsor of 23 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
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

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.

    For subjects being re-evaluated for participation in the VXA-CoV2-1.1-S boost substudy the following will also be exclusionary:

  17. Laboratory values outside the range of normal for platelet counts and the following coagulation tests: PT/INR, aPTT, fibrinogen, and D-dimer.

  18. Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:

    e. Family or personal history of bleeding or thrombosis f. History of heparin-related thrombotic events, and/or receiving heparin treatments g. History of autoimmune or inflammatory disease h. Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:

    • Recent surgery other than removal/biopsy of cutaneous lesions
    • Immobility (confined to bed or wheelchair for 3 or more successive days)
    • Head trauma with loss of consciousness or documented brain injury
    • Receipt of anticoagulants for prophylaxis of thrombosis
    • Recent clinically significant infection
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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

  • Experimental
    High Dose

    High Dose (1E11 I.U.) of VXA-CoV2-1 oral tableted vaccine dispensed at Day 1

    Biological: VXA-CoV2-1

Interventions

  • BiologicalVXA-CoV2-1

    non replicating Ad5 adjuvanted oral tableted vaccine

06

What researchers measure

Primary outcomes

  1. Frequency of solicited symptoms of reactogenicity

    Subject reported symptoms of local and systemic reactogenicity

    Time frame: Day 1 through Day 8 post each immunization

  2. Grade of solicited symptoms of reactogenicity

    Subject reported symptoms of local and systemic reactogenicity

    Time frame: Day 1 through Day 8 post each immunization

  3. Frequency of unsolicited adverse events

    Any adverse events observed or reported following vaccination

    Time frame: Day 1 through Day 29 post each immunization

  4. Grade of unsolicited adverse events

    Any adverse events observed or reported following vaccination

    Time frame: Day 1 through Day 29 post each immunization

  5. Frequency of serious adverse events (SAEs)

    Any adverse events reported following vaccination meeting definition of serious

    Time frame: Day 1 through Day 390

  6. Frequency of medically-attended adverse events (MAAEs)

    Any adverse events reported following vaccination meeting definition of serious

    Time frame: Day 1 through Day 390

Secondary outcomes

  1. SARS-CoV-2 specific IgG/IgA

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

    Time frame: Day 1 through Day 390

  2. Neutralizing antibody titers to SARS-CoV-2

    serum based assay of Ab titers

    Time frame: Day 1 through Day 390

  3. Antigen-specific IgG/IgA antibody secreting (ASCs)

    ASCs by ELISpot

    Time frame: Day 1 through Day 44

  4. Th1/Th2 polarization

    Flow Cytometry

    Time frame: Day 1 through Day 44

Other outcomes

  1. SARS-CoV-2 specific IgG/IgA by enzyme-linked immunosorbent assay

    MSD

    Time frame: Days 1, 29, 180 and 360

  2. Neutralizing antibody titers to SARS-CoV-2

    serum based assay of Ab titers

    Time frame: Days 1, 29, 180 and 360

  3. Antigen-specific IgG/IgA antibody secreting assays (ASCs)

    ELISpot

    Time frame: Days 1 and Day 8

  4. Plasmablast immunophenotyping

    Flow Cytometry

    Time frame: Day 1 and Day 8

  5. Detection of antigen S-specific IgA

    Flow Cytometry

    Time frame: Day 1 and Day 8

  6. Detection of antigen S-specific IgA

    Nasal swabs (SAM Device)

    Time frame: Days 1, 29, 180, and 360

  7. Detection of antigen S-specific IgA

    Saliva

    Time frame: Days 1, 29, 180, and 360

  8. Cytof analysis of cell populations

    Whole blood-based analysis

    Time frame: Day 1 and Day 8

  9. IFN-g production/IL-4 production by T cells

    fresh whole blood/TrueCulture tube

    Time frame: Day 1 and Day 8

07

Study locations

1 site
  • WCCT
    Cypress, California 90630, United States
08

References and documents

Publications

  • Langel SN, Johnson S, Martinez CI, Tedjakusuma SN, Peinovich N, Dora EG, Kuehl PJ, Irshad H, Barrett EG, Werts AD, Tucker SN. Adenovirus type 5 SARS-CoV-2 vaccines delivered orally or intranasally reduced disease severity and transmission in a hamster model. Sci Transl Med. 2022 Aug 17;14(658):eabn6868. doi: 10.1126/scitranslmed.abn6868. Epub 2022 Aug 17. PubMed 35511920 ↗

Individual participant data

Plan to share: Undecided — A plan on how to share individual subject's outcomes will be defined within the next few months.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04563702
Lead sponsor
Vaxart
Responsible party
Sponsor
First posted
Sep 24, 2020
Start date
Sep 21, 2020
Primary completion
Oct 10, 2021
Completion
Oct 10, 2021
Last update
Jun 21, 2024

Study contacts

James Cummings, MD
study director · Vaxart, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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