Helivax Antex Biologics.
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].
Giudice
G D
GD
IRIS Research Center, Chiron SpA, Siena, Italy. giuseppe_del_giudice@chiron.it
D000276:Adjuvants, Immunologic / Q000235:genetics / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D001427:Bacterial Toxins / Q000235:genetics / Q000276:immunology / Q000494:pharmacology; D001428:Bacterial Vaccines / Q000276:immunology* / Q000494:pharmacology / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004768:Enterotoxins / Q000235:genetics / Q000276:immunology / Q000494:pharmacology; D004926:Escherichia coli / Q000235:genetics / Q000276:immunology; D029968:Escherichia coli Proteins; D005753:Gastric Mucosa / Q000276:immunology / Q000378:metabolism / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy / Q000276:immunology / Q000517:prevention & control*; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D018928:Immunity, Mucosal; D007114:Immunization / Q000379:methods*; D007070:Immunoglobulin A / Q000378:metabolism; D015164:Vaccines, Inactivated / Q000276:immunology / Q000494:pharmacology / Q000627:therapeutic use
D000276:Adjuvants, Immunologic; D001427:Bacterial Toxins; D001428:Bacterial Vaccines; D004768:Enterotoxins; D029968:Escherichia coli Proteins; D007070:Immunoglobulin A; D015164:Vaccines, Inactivated; C027538:heat-labile enterotoxin, E coli