Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults

Summary

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age. The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world. This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

Timeline

Start

2020-09-16

Primary completion

2021-06-21

Completion

2021-06-21

Publications

• Results Harutyunyan S, Neuhauser I, Mayer A, Aichinger M, Szijarto V, Nagy G, Nagy E, Girardi P, Malinoski FJ, Henics T. Characterization of ShigETEC, a Novel Live Attenuated Combined Vaccine against Shigellae and ETEC. Vaccines (Basel). 2020 Nov 16;8(4):689. doi: 10.3390/vaccines8040689.

Drugs

Indications