Clinical Trial: Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents

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

Official Title: A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni (Sm) Infection on the Immunogenicity of a Candidate TB Vaccine, MVA85A, in BCG-vaccinated African Adolescents

Brief Summary:

Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority.

Over a billion people worldwide are infected with one or more helminths. Helminths are parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that helminth infection may affect a person's response to a vaccine. In this trial the investigators hope to investigate whether Schistosoma mansoni infection affects adolescents' responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group for an effective TB vaccine.


Detailed Summary:
Sponsor: University of Oxford

Current Primary Outcome: T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. [ Time Frame: 8 weeks ]

To compare T cell immunogenicity in adolescents with and without S. mansoni infection.


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response. [ Time Frame: 8 weeks ]

Effects of S. mansoni infection on other aspects of the immune response following MVA85A immunisation.


Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: June 3, 2014
Date Started: June 2014
Date Completion:
Last Updated: January 29, 2015
Last Verified: January 2015