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MVA 85 A Protocol 011

MVA 85 A Protocol 011

Title:

A Phase I study evaluating the safety and immunogenicity of a new TB vaccine, MVA85A, in asymptomatic volunteers who are infected with either Mycobacterium tuberculosis (M.tb.), Human Immunodeficiency Virus (HIV) or both.

The objective of the study is to test safety and immunogenicity of the MVA85A vaccine.

Study Description:

The study methodology is open label, observation and descriptive safety study, including four groups of 12 participants (Group 1: M.tb infected; Group 2: Infected with HIV and TB; Group 3: HIV infected and not on ARV's; Group 4: HIV infected and stable on ARV's) recruited from the general population of Worcester area, and vaccinated with MVA85A.

The study timeline is between 2007 and 2011.

PI: Greg Hussey

Partners: Oxford University, EuropAID, Wellcome Trust