Vaccine Development

• Background
• Clinical Trials
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Aeras sponsored a Phase IIb — proof of concept — clinical trial in 2,797 infants in partnership with University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI) and the Oxford-Emergent Tuberculosis Consortium. The primary objective of this study was to further evaluate the safety profile of MVA85A in BCG-vaccinated, HIV-negative infants. A secondary objective evaluated the efficacy of MVA85A in preventing TB disease in BCG-vaccinated infants. Enrollment in the clinical trial occured between July 2009 and April 2011 with study follow up through September 2012.

Prior to the start of the Aeras-sponsored Phase IIb infant trial, MVA85A was studied in 524 patients enrolled in Phase I and Phase IIa clinical trials, including in: M. tuberculosis-infected adults in the United Kingdom and South Africa; HIV-infected adults in the UK and South Africa; infants in the Gambia; and adolescents, children, and infants in South Africa. 

Aeras is also sponsoring a Phase IIb - proof of concept - clinical trial of MVA85A in adults living with HIV. This trial is taking place in Senegal and South Africa.  In Dakar, Senegal, the trial is led by the Medical Research Council (The Gambia) led by the Laboratoire de Bacteriologie-Virologie du Centre Hospitalier Universitaire Aristide Le Dantec. In Cape Town, South Africa, the trial is led by the Clinical Infectious Diseases Research Initiative, University of Cape Town. The European and Developing Countries Clinical Trial Partnership (EDCTP) is primary funder of this trial.