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Helicobacter pylori is associated with gastritis, ulceration, and malignancy. Previous attempts to develop an effective vaccine against the bacterium have been unsuccessful. Investigators now report results of an industry-funded, single-center, phase III, randomized trial in China of an oral recombinant H. pylori vaccine using urease B subunit fused with heat-labile enterotoxin B subunit (derived from Escherichia coli).
In 2004 and 2005, 4464 healthy children (aged 6–15 years) without history of H. pylori infection were randomly assigned to receive the vaccine or placebo (vaccine excipients) on days 0, 14, and 28 after a 2-hour fast and ingestion of a buffer solution.
At 1 year after vaccination, fewer H. pylori infections had occurred in the…