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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Admin

Brief 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.

Detailed Summary:
Sponsor: GSK Vaccines Institute For Global Health S.r.l.

Current Primary Outcome: Number of subjects with solicited local and systemic adverse reactions after any vaccination [ Time Frame: 7 days after vaccination ]

Solicited local adverse reactions are Injection site Erythema, Induration, Pain Systemic adverse reactions are Headache, Arthralgia, Chills, Fatigue, Malaise, Myalgia, Fever


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IgG geometric mean concentrations (GMCs) as determined by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: 28 days after each vaccination ]
  • Percentage of subjects with seroresponse for anti- LPS S. sonnei [ Time Frame: 28 days after each vaccination ]
    Seroresponse is aimed to define a significant increase in post vaccination samples based on the biological performance of this specific serology assay
  • Percentage of subjects with titers post vaccination concentration ≥ 121 for anti-LPS S. sonnei [ Time Frame: 28 days after each vaccination ]
  • Percentage of subjects with seroresponse for anti- LPS S. sonnei by antibody titer at baseline [ Time Frame: 28 days after each vaccination ]


Original Secondary Outcome: Same as current

Information By: GSK Vaccines Institute For Global Health S.r.l.

Dates:
Date Received: February 1, 2016
Date Started: August 2016
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017