A Tuberculosis candidate vaccine MVA85A is set to be subjected to further investigational trail involving people infected with HIV in two African countries to generate important safety, immunogenicity and efficacy data.
Already the vaccine had reached full enrolment following the participation of more than 3000 infants in South Africa in the first proof-of-concept clinical trial.
The trial known as “phase11b proof-of-concept efficacy trial” would be conducted by Aeras and the Oxford-Emergent Tuberculosis Consortium at research sites in Senegal and South Africa in West and Southern Africa respectively.
The trial is the first proof-of-concept efficacy trial in people infected with HIV using MVA85A. MVA85A is developed by a joint venture between the University of Oxford, Emergent BioSolutions and Aeras.
More than 1,400 adults between the ages of 18 and 50 infected with HIV will be participating in the trial to be led by the United Kingdom Medical Research Council in the Gambia, Aeras and the University of Oxford.
University of Cape Town Institute of Infectious Disease and Molecular Medicine in Khayelitsha, South Africa and the Laboratoire de Bacteriologie-Virologie du Centre Hospitalier Universitaire Aristide le Dantec in Dakar, Senegal are the two sites were the study would be conducted.
TB kills 1.7 million people every year and more than two billion people worldwide are infected with TB. HIV positive people living in countries with high TB prevalence are 20 times likely to develop TB than those who are HIV negative.
A World Health Organisation in 2008 estimated 1.4 million new cases of TB among persons with HIV infection and noted that TB accounted for 23 per cent of AIDS-related deaths.
Charles Mgone, executive director of the European and Developing Countries Clinical Trials Partnership said that the clinical trials of new vaccine against TB must be an urgent priority.
“Too many lives are lost to TB especially among people living with HIV.” The TB and HIV co-epidemic is devastating, requiring a concerted global response,” Mgone noted.
Jim Connolly, President of Aeras said that a new, more effective TB vaccine would be game-changing in international efforts to eliminate TB globally by 2050.
Trial partner, Aeras stated in a release that the trial has the approval of the Medicines Control Council of South Africa, the South African Department of Health and the Comite National d Ethique pour la Recherche en Sante in Senegal while the Scientific Institute of Public Health in Belgium would be providing in-kind laboratory services for the study.