Abstract
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].
MeSH terms
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Adjuvants, Immunologic / genetics
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Adjuvants, Immunologic / pharmacology
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Adjuvants, Immunologic / therapeutic use
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Adult
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Bacterial Toxins / genetics
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Bacterial Toxins / immunology
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Bacterial Toxins / pharmacology
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Bacterial Vaccines / immunology*
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Bacterial Vaccines / pharmacology
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Bacterial Vaccines / therapeutic use
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Clinical Trials as Topic
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Enterotoxins / genetics
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Enterotoxins / immunology
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Enterotoxins / pharmacology
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Escherichia coli / genetics
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Escherichia coli / immunology
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Escherichia coli Proteins*
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Gastric Mucosa / immunology
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Gastric Mucosa / metabolism
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Gastric Mucosa / microbiology
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Helicobacter Infections / drug therapy
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Helicobacter Infections / immunology
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Helicobacter Infections / prevention & control*
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Helicobacter pylori / immunology*
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Humans
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Immunity, Mucosal
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Immunization / methods*
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Immunoglobulin A / metabolism
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Vaccines, Inactivated / immunology
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Vaccines, Inactivated / pharmacology
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Vaccines, Inactivated / therapeutic use
Substances
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Adjuvants, Immunologic
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Bacterial Toxins
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Bacterial Vaccines
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Enterotoxins
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Escherichia coli Proteins
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Immunoglobulin A
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Vaccines, Inactivated
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heat-labile enterotoxin, E coli