Phase 1 and Phase 2 Studies of<i>Salmonella enterica</i>Serovar Paratyphi A O-Specific Polysaccharide-Tetanus Toxoid Conjugates in Adults, Teenagers, and 2- to 4-Year-Old Children in Vietnam

Konadu, Edward Y.; Lin, Feng-Ying C.; Hó, Vô Anh; Thủy, Nguyễn Thị Thanh; Bay, Phan Van Be; Thanh, Tran Cong; Khiem, Ha Ba; Trach, Dang Duc; Karpas, Arthur B.; Li, Jianping; Bryla, Dolores A.; Robbins, John B.; Szu, Shousun C.

doi:10.1128/iai.68.3.1529-1534.2000

Cited by 65 publications

(47 citation statements)

References 51 publications

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“…None of the licensed typhoid vaccines protect against paratyphoid fever. However, a candidate paratyphoid vaccine consisting of a modified O-specific polysaccharide of its lipopolysaccharide conjugated to tetanus toxoid has been developed and undergone Phase I and II trials in Vietnamese adults and children [23]. This North Jakarta study site could be a potential area for the evaluation of paratyphoid vaccines.…”

Section: Discussionmentioning

confidence: 99%

Enteric fever burden in North Jakarta, Indonesia: a prospective, community-based study

Punjabi¹,

Agtini

Ochiai

et al. 2013

J Infect Dev Ctries

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Introduction: We undertook a prospective community-based study in North Jakarta, Indonesia, to determine the incidence, clinical characteristics, seasonality, etiologic agent, and antimicrobial susceptibility pattern of enteric fever. Methodology: Following a census, treatment centre-based surveillance for febrile illness was conducted for two-years. Clinical data and a blood culture were obtained from each patient. Results: In a population of 160,261, we detected 296 laboratory-confirmed enteric fever cases during the surveillance period, of which 221 (75%) were typhoid fever and 75 (25%) were paratyphoid fever. The overall incidence of typhoid and paratyphoid cases was 1.4, and 0.5 per thousand populations per year, respectively. Although the incidence of febrile episodes evaluated was highest among children under 5 years of age at 92.6 per thousand persons per year, we found that the burden of typhoid fever was greatest among children between 5 and 20 years of age. Paratyphoid fever occurred most commonly in children and was infrequent in adults. Conclusion: Enteric fever is a public health problem in North Jakarta with a substantial proportion due to paratyphoid fever. The results highlight the need for control strategies against enteric fever.

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Section: Discussionmentioning

confidence: 99%

Enteric fever burden in North Jakarta, Indonesia: a prospective, community-based study

Punjabi¹,

Agtini

Ochiai

et al. 2013

J Infect Dev Ctries

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“…Only one Salmonella Paratyphi A vaccine, CVD 1902, has been evaluated in a phase 1 clinical trial (registered at ClinicalTrials.gov [https: //clinicaltrials.gov] under registration number NCT01129453) (K. Kotloff, personal communication), and it was found to be safe. Several conjugate vaccine approaches are also under investigation in preclinical studies (23)(24)(25).…”

Section: Salmonella Vaccinesmentioning

confidence: 99%

Animal Models for Salmonellosis: Applications in Vaccine Research

Higginson

Simon

Tennant

2016

Clin Vaccine Immunol

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Salmonellosis remains an important cause of human disease worldwide. While there are several licensed vaccines for Salmonella enterica serovar Typhi, these vaccines are generally ineffective against other Salmonella serovars. Vaccines that target paratyphoid and nontyphoidal Salmonella serovars are very much in need. Preclinical evaluation of candidate vaccines is highly dependent on the availability of appropriate scientific tools, particularly animal models. Many different animal models exist for various Salmonella serovars, from whole-animal models to smaller models, such as those recently established in insects. Here, we discuss various mouse, rat, rabbit, calf, primate, and insect models for Salmonella infection, all of which have their place in research. However, choosing the right model is imperative in selecting the best vaccine candidates for further clinical testing. In this minireview, we summarize the various animal models that are used to assess salmonellosis, highlight some of the advantages and disadvantages of each, and discuss their value in vaccine development.A nimal models are indispensable tools for assessing candidate vaccines, with preclinical animal safety, immunogenicity, and efficacy data being prerequisite for regulatory agencies such as the U.S. Food and Drug Administration (FDA) prior to undertaking early-stage clinical trials. However, not all animal models are created equal. While some models are highly robust and closely mimic clinical infection, others are contrived and far removed from clinical relevance. Choosing the right animal model for the vaccine under investigation is imperative in determining its safety and/or effectiveness.Salmonella spp. are often used as model organisms to study bacterial pathogenesis and host-microbe interactions, due to the ability of certain Salmonella serovars to readily infect animals. As such, there are a myriad of animal models available to vaccine developers. These range from colonization or lethality models to those involving complex surgical techniques (Table 1). The choice of model is often related not only to relevance but also cost, ethics, housing requirements, and the availability of appropriate technical expertise. While most researchers utilize one model or another, integration of data from multiple animal models can provide a more complete understanding of the safety of a candidate vaccine and/or predict how a potential vaccine may perform in humans. In this minireview, we provide background on Salmonella clinical syndromes and pathogenesis and then summarize the various animal models that have been used for Salmonella vaccine research. We include a brief discussion of the technical aspects, advantages, and limitations of each model, followed by a review of the literature surrounding its use in vaccine evaluation. While there has been considerable development for veterinary Salmonella vaccines, here we will focus solely on vaccines and models for human salmonellosis.

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“…Vaccines are being developed to protect against infection with the diarrhea-causing enteric pathogens noroviruses (138), Campylobacter jejuni (139), C. difficile (140), EPEC (141), E. histolytica (142), Cryptosporidium spp. (143,144), and EAEC as well as the enteric fever-causing pathogens Salmonella Paratyphi A and Salmonella Paratyphi B (145).…”

Section: Enteric Vaccinesmentioning

confidence: 99%

Enteric infections, diarrhea, and their impact on function and development

Petri¹,

Miller²,

Binder³

et al. 2008

J. Clin. Invest.

385

293

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Enteric infections, with or without overt diarrhea, have profound effects on intestinal absorption, nutrition, and childhood development as well as on global mortality. Oral rehydration therapy has reduced the number of deaths from dehydration caused by infection with an enteric pathogen, but it has not changed the morbidity caused by such infections. This Review focuses on the interactions between enteric pathogens and human genetic determinants that alter intestinal function and inflammation and profoundly impair human health and development. We also discuss specific implications for novel approaches to interventions that are now opened by our rapidly growing molecular understanding.

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Phase 1 and Phase 2 Studies ofSalmonella entericaSerovar Paratyphi A O-Specific Polysaccharide-Tetanus Toxoid Conjugates in Adults, Teenagers, and 2- to 4-Year-Old Children in Vietnam

Cited by 65 publications

References 51 publications

Enteric fever burden in North Jakarta, Indonesia: a prospective, community-based study

Enteric fever burden in North Jakarta, Indonesia: a prospective, community-based study

Animal Models for Salmonellosis: Applications in Vaccine Research

Enteric infections, diarrhea, and their impact on function and development

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