NCT06672055

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection

A Phase 2b, Double-Blind, Multi-Center, Randomized, Comparator-Controlled Trial to Determine the Relative Efficacy, Safety, and Immunogenicity of the Investigational Oral SARS-CoV-2 Vaccine Tablet Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10,400 (estimated)
• Sponsor: Vaxart · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine.

Conditions

• SARS-CoV2
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	VXA-CoV2-3.1	Tablets for oral use.
BIOLOGICAL	COMIRNATY®	Intramuscular (IM) injection.
BIOLOGICAL	VXA-CoV2-3.3	Tablets for oral use.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-11-04
• Last updated: 2025-10-22

Locations

145 sites across 1 country: United States

Regulatory

• FDA-regulated drug study