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Helicobacter pylori

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Human Challenge Studies for Vaccine Development

Part of the book series: Current Topics in Microbiology and Immunology ((CT MICROBIOLOGY,volume 445))

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Abstract

Helicobacter pylori (H. pylori) is an important human pathogen etiologically associated with peptic ulcers and gastric cancer. The infection is present in approximately one-half of the world’s population. Population-based H. pylori eradiation has confirmed that cure or prevention of the infection produces a marked reduction in gastric cancer and peptic ulcer disease. Antimicrobial therapy has become increasingly ineffective, and complexity and costs of antimicrobial therapy for infected individuals residing in and, immigrating from, the developing world combined with the cost of treatment for cancer make vaccine development a cost-effective alternative. Challenge studies allowed making a “go–no go” decision regarding vaccine effectiveness. We provide detailed protocols regarding challenge strain selection and administration as well as guidance regarding the clinical and laboratory tests used to confirm and monitor experimental infection. Experience shows that reliance of noninvasive methods led to the erroneous conclusion that some subjects were not infected. The current data suggests that histologic assessment of gastric mucosal biopsies may be one of the most sensitive and specific means of assessment of the presence of experimental infection as well as of successful H. pylori eradication. We recommend detailed recommendations for acquiring, processing, embedding, sectioning, and examining the gastric biopsies.

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Support

Dr. Graham is supported in part by the Office of Research and Development Medical Research Service Department of Veterans Affairs, Public Health Service grant DK56338, which funds the Texas Medical Center Digestive Diseases Center.

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Authors and Affiliations

  1. Department of Medicine, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, RM 3A-390A (111D), 2002 Holcombe Boulevard, Houston, TX, 77030, USA

    David Y. Graham

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  1. David Y. Graham
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Correspondence to David Y. Graham .

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Editors and Affiliations

  1. GSK Vaccines, SIENA, Siena, Italy

    Fabio Bagnoli

  2. Siena, Italy

    Giuseppe Del Giudice

  3. GSK Vaccines, Siena, Italy

    Sanjay K. Phogat

  4. GSK Vaccines, SIENA, Siena, Italy

    Rino Rappuoli

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Graham, D.Y. (2021). Helicobacter pylori. In: Bagnoli, F., Del Giudice, G., Phogat, S.K., Rappuoli, R. (eds) Human Challenge Studies for Vaccine Development. Current Topics in Microbiology and Immunology, vol 445. Springer, Cham. https://doi.org/10.1007/82_2021_235

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