This is a Phase 1 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.

There will be a total of 35 participants divided into 3 cohorts.  The first cohort will be the "sentinels", 5 people who will receive 2 doses of the oral vaccine, day 1 and day 29.

Cohort 2 will consist of 15 people given one oral tablet with the dose of 1x10^10 I.U. And cohort 3 consisting of 15 people with a dose of 5x10^10 I.U.

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.

Interim Results

Vaxart presented on 5/3/2021 VXA-COV2-101 observations from this Phase 1 clinical trial

Solicited Symptoms Post Vaccination:

Most Solicited Adverse Events mild and transient few moderates @ Days 2 to 6; 6 Mild unsolicited AEs: sore throat, epistaxis, chills, dry sinus, back pain & testicular pain; No SAEs or MAAEs reported to date

Response to the Oral Vaccine:

Vaxart’s oral vaccine candidate shows preferential Th1 responses, inducing a strong CD8 cytotoxic response

Vaxart’s Oral Vaccine candidate generates robust CD8 T cell responses

Vaxart’s Oral Vaccine candidate generates robust CD8 T cell responses – Compares favorably to the mRNA vaccines

Vaxart immunized subjects have increased cross-reactive nasal IgA response to other coronaviruses

Phase II efficacy study planned for later this year.