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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BNT162b2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | VXA-CoV2-3.1 | Vaccine | — | Oral |
| Subject | VXA-CoV2-3.3 | Vaccine | — | Oral |