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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

Summary

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.

Description

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

Conditions

Salmonella

Intervention

CVD 1902, a Salmonella enterica Serovar Paratyphi A live, oral vaccine, Placebo

Location

University of Maryland, Baltimore Center for Vaccine Development
Baltimore
Maryland
United States
21201

Status

Recruiting

Source

University of Maryland

Results (where available)

View Results

Links

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.

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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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