Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

Timeline

Start

2016-07-29

Primary completion

2016-10-05

Completion

2017-10-01

Outcome

Met primary endpoint

paper The primary immunological endpoint (increase in BT50 titers) was met in the high-dose group (P = 0.0003) PMID 29997294 ↗

Publications

• Kim L, Liebowitz D, Lin K, Kasparek K, Pasetti MF, Garg SJ, Gottlieb K, Trager G, Tucker SN. Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial. JCI Insight. 2018 Jul 12;3(13):e121077. doi: 10.1172/jci.insight.121077.

Drugs

Indications