A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Summary
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Timeline
- Start
- 2023-01-26
- Primary completion
- 2023-10-16
- Completion
- 2023-10-16
Outcome
Met primary endpoint
registry analysis (superiority test); Bivalent GI.1/GII.4 Vaccine Medium Dose vs Placebo; p <.0001; ANCOVA NCT05626803 ↗
registry analysis (superiority test); Bivalent GI.1/GII.4 Vaccine High Dose vs Placebo; p <.0001; ANCOVA NCT05626803 ↗
registry analysis (superiority test); Bivalent GI.1/GII.4 Vaccine Medium Dose vs Placebo; p = 0.0059; ANCOVA NCT05626803 ↗
registry analysis (superiority test); Bivalent GI.1/GII.4 Vaccine High Dose vs Placebo; p = 0.0020; ANCOVA NCT05626803 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VXA-G1.1-NN | Vaccine | 5e+10 unknown | Oral |
| Subject | VXA-G1.1-NN | Vaccine | 1e+11 unknown | Oral |
| Subject | VXA-GII.4-NS | Vaccine | 5e+10 unknown | Oral |
| Subject | VXA-GII.4-NS | Vaccine | 1e+11 unknown | Oral |