h.pylori control: antibiotics and vaccine development

H. Pylori infection

While an estimated one half of the world’s population is infected with H. pylori, the levels of infection are considerably greater in countries of low socio-economic status (a major risk fac- tor for H. pylori infection). Infection with H. pylori is a proven cause of a range of diseases including gastric and duodenal ulcers (peptic ulcer disease), gastric MALT (mucosal associated lymphoid tissue) lymphoma, and gastric adenocarcinoma (hereafter gastric cancer). There is reasonable evidence that this infection is also a cause of at least some cases of Immune Thrombocytopenic Purpura (ITP).

The most serious consequence of H. pylori infection, and the key reason a vaccine is required, is gastric cancer which globally is the 3rd leading cause of death due to cancer. Gastric cancer is the 5th most common malignancy and the 3rd leading cause of cancer-related deaths world- wide. The prevalence of gastric cancer is particularly high in Asian countries, especially China, Japan and South Korea, where H. pylori infection has a high prevalence.  

H. pylori infections are currently treatable with combination antimicrobial therapies, although antibiotic resistance is a major concern. A failure rate of over one in four, in addition to almost half the volunteers not completing the trial, suggest significant challenges for population- wide implementation of antimicrobial eradication of H. pylori. 

h.pylori vaccine development

An effective vaccine against H. pylori therefore remains a preferential option, especially for low income population who would particularly benefit given the high prevalence of disease associated with this infection in these countries and the likely lower costs of a vaccine approach as compared to other strategies. Importantly, while there are few definitive studies, a vaccine against H. pylori that reduces the incidence of gastric cancer will likely be cost-effective in both developed countries and in low income countries. 
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The development of a vaccine to prevent or eradicate H. pylori infection has proven extremely challenging. Vaccinating with a surprisingly wide range of antigens, adjuvants and delivery systems can produce a modest reduction in H. pylori colonization levels in mice, However attempts to translate this partial success in animal models to clinical trial have proven unsuccessful. The majority of early H. pylori vaccine clinical trials focused on the urease antigen with different adjuvants, routes and delivery systems generally proving ineffective in humans. 

our strategy: immunotherapy with milk

New therapeutic strategies are needed to solve the problems mentioned above. The approach of passive immunization with orally administered antibodies against H. pylori is likely to constitute one of the new therapeutic strategies. This approach mimics naïve protection in humans and has been shown to be effective in the prevention and treatment of a variety of pathogens, such as Rotavirus, Clostridium difficile, and Campylobacter jejuni. Many animal studies have shown that bovine antibody- containing milk against H. pylori reduces bacterial load, thus preventing and even eradicating H. pylori infection.  The use of anti-H. pylori bovine antibodies in milk to control the H.pylori infection has many advantages such as low costs, nutrients, and good compliance, without the development of antibiotic resistance in H. pylori or other ora and the tolerance of long-term use. 

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current progress

Phase 1 results are promising, showed 42.86% H.Pylori clearance rate. Phase 2 study have enrolled more than 200 patients.