Phase I Safety and Efficacy Study of CVD 1902, a Live, Attenuated Oral Vaccine to Prevent Salmonella Enterica Serovar Paratyphi A Infection

2014-08-27 03:13:27 | BioPortfolio


The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine) is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.


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.

Study Design

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
United States




University of Maryland

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:27-0400

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Medical and Biotech [MESH] Definitions

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.

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A prolonged febrile illness commonly caused by several Paratyphi serotypes of SALMONELLA ENTERICA. It is similar to TYPHOID FEVER but less severe.

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