Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

Summary

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for \~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group \~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

Timeline

Start

2019-03-20

Primary completion

2021-01-15

Completion

2021-04-01

Drugs

Indications