The regulatory and ethics submissions of all TB vaccine trial protocols conducted by SATVI since its first phase 1 trial of a novel TB vaccine in 2004 were included in this analysis.
South African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IIDMM); and School of Child and Adolescent Health, Facutly of Health Sciences, University of Cape Town
The personnel complement of SATVI has grown from 3 to more than 190 persons over 10 years, more than 20 000 participants have been enrolled into studies, funding support now exceeds R50 million a year, 80 research articles have been published in mid- to high-impact journals, and multiple PhD, MSc and MPH candidates have graduated.
SATVI has conducted clinical trials of 5 new TB vaccine candidates, (6-8) in 11 different protocols.
The results of the trial of MVA85A, involving 2 797 infants, and conducted exclusively at SATVI, are expected to be available at the beginning of 2013.
As a principle, SATVI uses registration-standard vaccine trials to explore other critical areas in vaccine development.
SATVI's flagship immunology projects address the holy grail of vaccine development--immune correlates of protection against TB.
A major contributor to SATVI's success has been productive partnerships with relevant local and international academics.
A newer formulation of the vaccine, M72, is currently undergoing clinical trials in Europe, with further trials planned for the SATVI site in South Africa in late 2007.
The first trial in South Africa is due to start at the SATVI site near Cape Town in mid-2007.
The main objectives of the SATVI, a research unit within the Institute of Infectious Diseases and Molecular Medicine at UCT, are to develop the capacity of our rural site in Worcester to do phase I to phase IV TB vaccine trials, to determine important epidemiological characteristics that are of relevance to TB in the area and to identify clinical, microbiological and immunological endpoints of key importance to all stages of vaccine trials.
The work of SATVI is supported by a number of international donors including the Aeras Global TB Vaccine Foundation, the National Institutes for Heath, USA, the European Union and the Welcome Trust.