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Experimental Helicobacter Pylori Infection in Humans 1220 COMMENTARIES H pylori validate animal models for pathogenesis ....................................................................................... studies. In addition to its use in studying the Gut: first published as 10.1136/gut.2004.043281 on 11 August 2004. Downloaded from pathogenesis of infectious diseases, Experimental Helicobacter pylori infection inducing challenge experi- ments have been used to evaluate the infection in humans: a multifaceted initial efficacy of vaccines before con- ducting large scale field tests for many challenge infectious diseases, including enteric pathogens.9 Typically, this step is under- P Michetti taken after basic research has provided data regarding potential protective anti- ................................................................................... gens, and allowed for a description of the host immune response. Then, Is there a scientific rationale for the use of an infection challenge ideally, animal models that mimic human model for Helicobacter pylori vaccine development in humans? infection and response are used to test efficacy before human studies are con- hallenge experiments have been the conditions required for exposure to sidered. Finally, candidate vaccine prep- arations should then be evaluated for an important method of studying H pylori to lead to chronic gastric safety and immunogenicity in humans, the pathogenesis of many infec- infection, and the early clinical and C outside of the challenge setting, to mini- tious diseases and of evaluating initial pathological events following colonisa- mise exposure of volunteers only to the efficacy of vaccines before large scale tion of the gastric mucosa.5 Indeed, the 12 most promising candidates. In this field tests are conducted. In challenge infection is typically acquired in child- instance, however, it is of central impor- experiments, infections are deliberately hood but most studies related to H pylori tance to determine whether the proposed induced under carefully controlled pathogenesis and host response are human challenge model is not only suited and monitored conditions to healthy conducted, for obvious ethical and to reproduce the natural infection but also research volunteers. Induced infections practical reasons, in adults. As young corresponds to the population that the are usually either self limiting or can be children are not always chronically vaccine is intended to protect. fully treated within a short period of infected following initial infection,6 a Vaccine development against H pylori time. Because physicians should be better understanding of the early phase started over 10 years ago, after a proof dedicated to alleviating disease and of the infection may prove useful in the of principle was established in mice avoiding harm to patients, this type of development of novel therapies and infected with Helicobacter felis.10 11 In this experiment may cause uncomfortable vaccines. Although it is not entirely model, and later in H pylori mouse symptoms and evoke serious moral clear that the early events in H pylori models, several protective antigens of concerns. It should be appreciated how- infection in adults are identical to those ever that clinical research commonly H pylori were identified. Urease was also in children during natural infection, shown to be effective in a vaccine involves risks to subjects that are not adult infection has been reported and http://gut.bmj.com/ outweighed by medical benefits but are 7 preparation administered to infected has led to typical chronic infection. A H animals.12 Urease, cytotoxin associated justified by the potential to acquire new pylori challenge model in adults may knowledge.3 In that regard, infection gene A (CagA), vacuolating cytotoxin thus present an unique opportunity to inducing challenges are not necessarily (VacA), and H pylori neutrophil activat- obtain information on the pathogenesis more ethically problematic than phase I ing protein (HpNAP) were also shown of this bacterium, which may be poten- trials aimed at determining maximum to be safe and immunogenic in humans tially useful in the development of tolerated doses of medications. Like any once their protective potential had been new drugs or obtaining knowledge on 13 on September 25, 2021 by guest. Protected copyright. clinical research, challenge experiments established in mice. Although these the host response crucial for vaccine should be conducted by competent antigens are protective in mice, and development. investigators according to sound pro- elicit both humoral and cellular immune tocols that incorporate appropriate By inducing experimental H pylori responses, no clear immune correlate of infection in healthy volunteers, the protection could be identified in mice, safeguards to ensure the safety of 8 volunteers. Because these experiments report of Graham and colleagues in this which prevents the use of an immuno- may provide valuable information that issue of Gut has certainly contributed to logical test to evaluate the protective might not be otherwise obtained, lead to our understanding of this infection (see potential of a candidate vaccine in novel therapies, or speed up vaccine page 1235). This study provides valu- humans.14 Field trials thus represent development that will ultimately spare able information on the low inoculum the alternative, with protection as the morbidity or death from infectious dis- size required for infection, the impact of primary outcome. As H pylori infection is eases and reduce exposure of large some virulence factors, the symptoms acquired early in life, this would imply groups in field trials, challenge experi- associated with acute H pylori infection, that field trials would have to be ments may be justified.4 However, the the physiological changes induced by conducted in children, in areas of high scientific rationale should be carefully H pylori, as well as on the rapid devel- incidence (that is, on the less favoured examined for any given pathogen and opment of histological changes pre- children of most societies). If a pro- model. When such a rationale exists, viously thought to be linked to chronic phylactic vaccine is to be developed, then the question of risks and discom- infection. This harvest of valuable infor- such a field approach would certainly forts should be addressed. mation would have been very difficult elicit several serious ethical concerns. Twenty years after the first culture of to obtain by other means, especially if These concerns may be progressively Helicobacter pylori there are still many early infection is to be analysed in addressed if benefit can be shown for gaps in our knowledge of this world- children. These data represent a well children but the incentive to invest in wide infection. In particular, little infor- controlled body of information, useful the long research needed to follow that mation is available regarding the precise to the scientific community, to better approach would certainly be helped by mode of transmission of the infection, understand transmission and to further positive results in adults. As natural www.gutjnl.com COMMENTARIES 1221 infection is rare in adults, a challenge associated with decreased eradication therefore needs to think carefully before model would then be required to pro- rates. Despite this, full confidence that deciding to use this model in humans gress substantially towards prophylactic H pylori infection, even with a fully for the development of a vaccine against Gut: first published as 10.1136/gut.2004.043281 on 11 August 2004. Downloaded from vaccine development. In this context, antibiotic sensitive strain, can be eradi- H pylori. the model developed by Graham and cated is lacking. Volunteers that might Gut 2004;53:1220–1221. 8 colleagues certainly represents an remain infected would then be at doi: 10.1136/gut.2004.042135 advance. The value of this adult model increased risk, albeit a small risk, of in predicting vaccine induced protection morbidity. In addition, as the precise Correspondence to: Professor P Michetti, in children however would further transmission mode of is as yet Division of Gastroenterology and Hepatology, H pylori BH10N-545, Centre Hospitalier Universitaire depend on the assumptions that both unclear, there was a small risk that the Vaudois, CH-1011 Lausanne, Switzerland; infection and vaccine induced protective experimental strain would pass to other [email protected] responses are similar in adults and individuals. In the course of their study, children. In addition, the model would Graham et al achieved 100% eradication REFERENCES not be appropriate for testing the rate, and no apparent transmission of 1 Sack DA, Tacket CO, Cohen MB, et al. Validation protective potential of CagA, as the the infection was observed, possibly of a volunteer model of cholera with frozen strain was selected as CagA negative related to the precautions undertaken bacteria as the challenge. Infect Immun for safety reasons. As virulence factors to minimise this risk. The size of the 1998;66:1968–72. often represent important vaccine anti- experiment however was far too small 2 Tacket CO, Binion SB, Bostwick E, et al. Efficacy of bovine milk immunoglobulin gens, this is certainly a limitation of the to ascertain that the strain can be safely concentrate in preventing illness after Shigella model which could be resolved only eradicated and is not transmitted, with flexneri challenge. Am J Trop Med Hyg after extensive safety data are obtained type
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