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A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults

2016-02-08 19:08:21 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Shigella Sonnei Infection

Intervention

S. sonnei vaccine 25 μg, S. sonnei vaccine 100 μg, Menveo, Boostrix

Location

KEMRI-Wellcome Trust Research Programme
Kilifi
Kenya
80108

Status

Not yet recruiting

Source

GSK Vaccines Institute For Global Health S.r.l.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-02-08T19:08:21-0500

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Medical and Biotech [MESH] Definitions

DYSENTERY caused by gram-negative rod-shaped enteric bacteria (ENTEROBACTERIACEAE), most often by the genus SHIGELLA. Shigella dysentery, Shigellosis, is classified into subgroups according to syndrome severity and the infectious species. Group A: SHIGELLA DYSENTERIAE (severest); Group B: SHIGELLA FLEXNERI; Group C: SHIGELLA BOYDII; and Group D: SHIGELLA SONNEI (mildest).

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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...


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