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Enteric fever is a life-threatening illness caused by several types of a bacterium known as Salmonella, including Salmonella Paratyphi A. In the United States about 400 cases occur each year, and 75% of these are acquired while traveling internationally. Typhoid fever is still common in the developing world, where it affects about 21.5 million persons each year.Besides being a first step towards a possible oral paratyphoid A vaccine for the prevention of enteric fever, this Phase 1 trial will shed light on the suitability of the guaBA,clpX strategy for attenuating non-typhoidal Salmonella, also an emerging pathogens of public health importance. This randomized, double-blinded, Phase I study in healthy is designed to investigate the safety, clinical tolerability, and immunogenicity in a dose escalating fashion of a live, oral, attenuated S. Paratyphi A at four dose levels (10^6, 10^7, 10^8, and 10^9 CFU). We hypothesize that S. Paratyphi A strains harboring mutations in guaBA and clpX will be well tolerated in the full dose range tested and that a single inoculation at the highest dose will elicit vigorous humoral and cell-mediated immune responses in humans.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
CVD 1902, a Salmonella enterica Serovar Paratyphi A live, oral vaccine, Placebo
University of Maryland, Baltimore Center for Vaccine Development
University of Maryland
Published on BioPortfolio: 2014-08-27T03:13:27-0400
In this Phase I clinical study, three recombinant, avirulent Salmonella Typhi (RASV) strains each expressing the Streptococcus pneumoniae surface protein, PspA, will be compared as live bi...
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Salmonella enterica serovars Typhi and Paratyphi, the causative agents of typhoid and paratyphoid, are major threats in developing countries. The present study aimed to investigate the resistance patt...
Characteristics of Resistance Mechanisms and Molecular Epidemiology of Fluoroquinolone-Nonsusceptible Salmonella enterica Serovar Typhi and Paratyphi A Isolates from a Tertiary Hospital in Dhaka, Bangladesh.
The aim of this study was to characterize the fluoroquinolone (FQ) resistance mechanism of Salmonella enterica serovar Typhi and Paratyphi A in Bangladesh. Salmonella Typhi isolates were classified in...
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Typhoid fever caused by Salmonella enterica serovar (S.) Typhi differs in its clinical presentation from gastroenteritis caused by S. Typhimurium and other non-typhoidal Salmonella serovars. The diffe...
Salmonella is a common and widely distributed foodborne pathogen that is frequently implicated in gastrointestinal infections. The emergence and spread of Salmonella strains resistant to multiple anti...
A serotype of SALMONELLA ENTERICA that causes mild PARATYPHOID FEVER in humans.
A serotype of SALMONELLA ENTERICA which is an agent of PARATYPHOID FEVER in humans.
A serotype of SALMONELLA ENTERICA which is an agent of PARATYPHOID FEVER in Asia, Africa, and southern Europe.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
A prolonged febrile illness commonly caused by several Paratyphi serotypes of SALMONELLA ENTERICA. It is similar to TYPHOID FEVER but less severe.
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
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