Drug intelligence / Profile preview

oral recombinant Helicobacter pylori vaccine

Development stage
Phase 3
Lead developer
Chongqing Kangwei Biotechnology
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

The oral recombinant Helicobacter pylori vaccine is a recombinant subunit fusion protein vaccine designed for the prophylaxis of *Helicobacter pylori* infection. It utilizes the urease B subunit (UreB) of *H. pylori* fused with the heat-labile enterotoxin B subunit (LTB) of *Escherichia coli*, which serves as both a carrier and a mucosal adjuvant. Developed by the Third Military Medical University and Chongqing Kangwei Biotechnology, the vaccine is administered orally in a three-dose regimen (days 0, 14, and 28). It has demonstrated efficacy, safety, and immunogenicity in large-scale Phase 3 clinical trials involving *H. pylori*-naive children aged 6-15 years in China, significantly reducing the incidence of infection and associated risks such as gastritis and peptic ulcers.

Other names
UreB-LTB vaccinerecombinant Helicobacter pylori vaccineKangwei H. pylori vaccine
02

Targets

LTB (Heat-labile enterotoxin B subunit)UreB (Urease subunit beta)

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