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

NCT04563702 | Completed Phase 1 FDA Drug

• 1 other identifier: VXA-COV2-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

VXA-C0V2-1; Vaxart oral vaccine; tablet vaccine; VXA-C0V2-1.1; Boost

Outcome Measures

Primary Outcomes (6)

• Frequency of solicited symptoms of reactogenicity

  Subject reported symptoms of local and systemic reactogenicity

  Day 1 through Day 8 post each immunization

• Grade of solicited symptoms of reactogenicity

  Subject reported symptoms of local and systemic reactogenicity

  Day 1 through Day 8 post each immunization

• Frequency of unsolicited adverse events

  Any adverse events observed or reported following vaccination

  Day 1 through Day 29 post each immunization

• Grade of unsolicited adverse events

  Any adverse events observed or reported following vaccination

  Day 1 through Day 29 post each immunization

• Frequency of serious adverse events (SAEs)

  Any adverse events reported following vaccination meeting definition of serious

  Day 1 through Day 390

• Frequency of medically-attended adverse events (MAAEs)

  Any adverse events reported following vaccination meeting definition of serious

  Day 1 through Day 390

Secondary Outcomes (4)

• SARS-CoV-2 specific IgG/IgA

  Day 1 through Day 390

• Neutralizing antibody titers to SARS-CoV-2

  Day 1 through Day 390

• Antigen-specific IgG/IgA antibody secreting (ASCs)

  Day 1 through Day 44

• Th1/Th2 polarization

  Day 1 through Day 44

Other Outcomes (9)

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

  Days 1, 29, 180 and 360

• Neutralizing antibody titers to SARS-CoV-2

  Days 1, 29, 180 and 360

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

  Days 1 and Day 8

Study Arms (2)

Low Dose VXA-CoV2-1

EXPERIMENTAL

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

High Dose

EXPERIMENTAL

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

Biological: VXA-CoV2-1

Interventions

VXA-CoV2-1 BIOLOGICAL

non replicating Ad5 adjuvanted oral tableted vaccine

High Dose; Low Dose VXA-CoV2-1

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between the ages of 18 to 54 years, inclusive.
• Negative for SARS-CoV-2 infection at the time of screening
• In generally good health, without significant medical illness
• Demonstrates comprehension of the protocol procedures and is able to provide written informed consent.
• Available for all planned visits and willing to complete all protocol defined procedures and assessments
• Body mass index between 17 and 30 kg/m2 at screening.
• Female subjects must have a negative pregnancy test at screening and before each vaccination and fulfill an acceptable method of birth control (per protocol)

You may not qualify if:

• 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).
• Is in a current occupation with high risk of exposure to SARS-CoV-2
• 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
• Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
• Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
• Any condition that resulted in the absence or removal of the spleen.
• Positive HIV, HBsAg or HCV tests at the screening visit.
• Stool sample with occult blood at screening.
• Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 7 days before vaccination
• 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
• Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 7 days before vaccination
• Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness
• History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug screen for drugs of abuse at screening
• History of hypersensitivity or allergic reaction to any component of the investigational vaccine
• Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination

Sponsors & Collaborators

• Vaxart: lead

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

Related Publications (1)

• 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.

  PMID: 35511920 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

VXA-CoV2-1 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James Cummings, MD

  Vaxart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, repeat dose, dose ranging

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: September 21, 2020
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: June 21, 2024

Record last verified: 2022-09

Locations

US (1)