drugset / Trial / 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

NCT06672055

Phase 2 Active not recruiting 5485 enrolled Vaxart
RandomizedSequentialDouble-blindPrevention

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.

Timeline

Start
2024-10-08
Primary completion
2027-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator BNT162b2 Messenger RNA (mRNA) Intramuscular
Subject VXA-CoV2-3.1 Vaccine Oral
Subject VXA-CoV2-3.3 Vaccine Oral

Indications