Prophylactic and therapeutic immunization

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As we have seen, effective therapies against Helicobacter require the child to ingest multiple drugs several times a day for at least 1 week.106 The common occurrence of adverse effects (nausea, diarrhea, abdominal pain and, more rarely, pseudomembranous colitis), the frequently observed low compliance and the high costs suggest the need to evaluate different approaches.

Despite the fact that patients infected with H. pylori have a systemic and local immune response,57 this response does not resolve the infection. Studies on H. pylori-specific cellular immunity suggested that H. pylori induces a pro-inflammatory cascade and a Th1 response that contributes to the chronicity (Figure 6.2). Since 1993, several groups have developed animal models of Helicobacter infection.122 Using the mouse model, oral immunization with H. felis lysates with cholera toxin (CT) as adjuvant resulted in 76-96% of protection. Others challenged the same models using H. pylori antigens such as Vac-A, Cag-A, catalase or urease B subunit. On the basis of the results of clinical therapeutic vaccination trials, it is likely that several antigens are needed for a subunit vaccine in humans.

Several groups administered the vaccine to infected animals for therapeutic and not for prophylactic use. Oral vaccination of H. felis-infected mice with either bacterial sonicate or H. pylori urease B subunit plus CT cured approximately half of the mice. Several groups have now developed murine models of H. pylori infection. Eradication in 70-92% was achieved by using recombinant Cag-A or Vac-A as oral antigens, respectively.

Studying the H. mustelae ferret model, which represents a natural host-pathogen disease, therapeutic immunization with H. pylori urease and CT achieved eradication in one-third of ferrets.

Recently, a clinical trial tested an oral therapeutic vaccine consisting of recombinant H. pylori urease apoenzyme coupled with Escherichia coli LT in humans; a significant reduction in gastric H. pylori density was achieved along with an increase of specific IgA-producing cells.123

A different approach was based on the development of attenuated recombinant enteric pathogens expressing Helicobacter antigens. Cloning of urease A and B subunits in an attenuated strain of Salmonella typhimurium achieved protection in mice. Recently, the safety and immunogenicity of live recombinant Salmonella typhi vaccine expressing urease A and B from H. pylori in human volunteers has been tested with encouraging results.124

In summary, these immunization studies are very promising, but at the same time indicate that many problems are still unsolved: what constitutes the best antigen, the safest adjuvant and the best route of administration? In spite of these uncertainties, it is evident that childhood vaccination could, in theory, prevent one of the most diffuse chronic infections in the world, avoiding consistent morbidity in adult life, and reducing the incidence of gastric cancer later in life.


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