Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial

RCT (n=4464 in H pylori-naive children) recorded 64 events of H pylori infection within first year (14 events in 2074.3 person-years at risk vaccine group vs. 50 events in 2089.6 person-years at risk placebo group), resulting in a vaccine efficacy of 71.8%.

The researchers suggest from these findings that this vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases.

 

In an accompanying commentary, the author (who has a patent relating to H pylori vaccines issued, and a patent relating to H pylori vaccines pending) notes that for a quarter of a century, countless attempts have been made to produce an effective vaccine against H pylori. However, efforts to produce such a vaccine have so far failed, and H pylori vaccine research has slowed in the past few years. He believes that despite limitations and concerns, this proof of concept study is a major step towards a vaccine that protects against gastric cancer, and he hopes it will rekindle interest in this important topic, and encourage increased investment in progression of new projects through to advanced clinical trials.