NCT04563702 is a Phase 1 clinical trial of VXA-CoV2-1 in Covid19, sponsored by Vaxart.

Who is sponsoring NCT04563702?

NCT04563702 is sponsored by Vaxart.

What drugs are being tested in NCT04563702?

Interventions in NCT04563702: VXA-CoV2-1.

Is NCT04563702 still recruiting?

NCT04563702 is currently completed. Last updated 21 June 2024.

Last reviewed 2024-06-21 · How we verify

NCT04563702

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 21 June 2024

What this trial tests

Phase 1 trial testing VXA-CoV2-1 in Covid19 in 35 participants. Completed in 10 October 2021.

Timeline

21 September 2020

Primary endpoint
10 October 2021

10 October 2021

Quick facts

Lead sponsor	Vaxart
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	35
Start date	21 September 2020
Primary completion	10 October 2021
Estimated completion	10 October 2021
Sites	1 location across United States

Drugs / interventions tested

VXA-CoV2-1 — full drug profile →

Conditions studied

Covid19 — all drugs for Covid19 →

Sponsor

Vaxart — full company profile →

Who can join

Adults 18 to 54, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Mucosal vaccines - fortifying the frontiers.
Lavelle EC, Ward RW. · · 2022 · cited 513× · PMID 34312520 · DOI 10.1038/s41577-021-00583-2
SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
Coronavirus vaccine development: from SARS and MERS to COVID-19.
Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
COVID-19 vaccines: rapid development, implications, challenges and future prospects.
Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic.
Mendonça SA, Lorincz R, Boucher P, Curiel DT. · · 2021 · cited 223× · PMID 34354082 · DOI 10.1038/s41541-021-00356-x
COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies.
Rawat K, Kumari P, Saha L. · · 2021 · cited 169× · PMID 33245898 · DOI 10.1016/j.ejphar.2020.173751
Viral vectored vaccines: design, development, preventive and therapeutic applications in human diseases.
Wang S, Liang B, Wang W, Li L, et al · · 2023 · cited 124× · PMID 37029123 · DOI 10.1038/s41392-023-01408-5
Oral nanomedicine for modulating immunity, intestinal barrier functions, and gut microbiome.
Lee Y, Kamada N, Moon JJ. · · 2021 · cited 108× · PMID 34710529 · DOI 10.1016/j.addr.2021.114021

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix · EARLY_PHASE1 · active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation · NA · recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs · NA · active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
NCT04806061 — Urine Alkalinisation in COVID-19 · NA · active not recruiting

Other Vaxart trials

Trials by the same sponsor.

NCT06944717 — A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years · Phase 1 · active not recruiting
NCT07254728 — A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing I · Phase 1 · completed
NCT05626803 — A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers · Phase 2 · completed
NCT05213728 — A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-v · Phase 1 · completed
NCT05212168 — Norovirus Challenge Study · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04563702 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vaxart
Last refreshed: 21 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04563702.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing