Helivax Antex Biologics
Giudice, G.D.
Current Opinion in Investigational Drugs 2(7): 896-899
2001
ISSN/ISBN: 1472-4472 PMID: 11757787 Document Number: 537434
Antex Biologics is developing an oral vaccine against Helicobacter pylori infection as a potential treatment and prophylaxis for gastric ulcers. The vaccine incorporates a mucosal adjuvant and is in phase II trials [376332]. Enrollment for the trial was completed in September 2000 and results are expected in 2001 [382128]. In July 2000, Antex started a two-part phase Ib/II clinical trial of the vaccine. The first part was an open-label study to assess the general safety of the vaccine in uninfected and asymptomatic Helicobacter pylori-infected individuals. The second part was an expanded placebo-controlled study to evaluate safety and immunogenicity of the vaccine. The vaccine was generally well-tolerated and it generated an immune response in both infected and non-infected individuals [312681].