Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults

Summary

To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.

Timeline

Start

2008-10

Primary completion

2010-03

Completion

2010-04

Outcome

Missed primary endpoint

paper Compared with placebo, the vaccine did not confer additional protection against H pylori infection after challenge with a CagA-positive strain PMID 30042064 ↗

Publications

• Malfertheiner P, Selgrad M, Wex T, Romi B, Borgogni E, Spensieri F, Zedda L, Ruggiero P, Pancotto L, Censini S, Palla E, Kanesa-Thasan N, Scharschmidt B, Rappuoli R, Graham DY, Schiavetti F, Del Giudice G. Efficacy, immunogenicity, and safety of a parenteral vaccine against Helicobacter pylori in healthy volunteers challenged with a Cag-positive strain: a randomised, placebo-controlled phase 1/2 study. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):698-707. doi: 10.1016/S2468-1253(18)30125-0. Epub 2018 Jul 2.
• Nell S, Estibariz I, Krebes J, Bunk B, Graham DY, Overmann J, Song Y, Sproer C, Yang I, Wex T, Korlach J, Malfertheiner P, Suerbaum S. Genome and Methylome Variation in Helicobacter pylori With a cag Pathogenicity Island During Early Stages of Human Infection. Gastroenterology. 2018 Feb;154(3):612-623.e7. doi: 10.1053/j.gastro.2017.10.014. Epub 2017 Oct 21.

Drugs

Indications