RTS,S malaria vaccine candidate

 

RTS,S is the world’s most clinically advanced malaria vaccine candidate. Its early development, beginning in the 1980s, was undertaken by GlaxoSmithKline Biologicals in close collaboration with the Walter Reed Army Institute of Research. In January 2001, GSK and the PATH Malaria Vaccine Initiative (MVI)—with grant money from the Bill & Melinda Gates Foundation to MVI—entered into a public-private partnership to develop the vaccine for use in infants and young children in sub-Saharan Africa.

In May 2009, RTS,S began large-scale Phase 3 clinical testing, typically one of the last steps before regulatory approval. The study involves 11 clinical trial sites in seven African countries – Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania. The trial completed enrollment in January 2011, with a total of 15,460 confirmed participants. Initial results from the study are expected in late 2011 with the final analysis anticipated in late 2014.

Data from previous studies indicate, among other things, that RTS,S may cut the number of episodes of malaria in young children by about half.

If all goes well in Phase 3 testing, the World Health Organization has indicated that a policy recommendation for RTS,S is possible as early as 2015, paving the way for countries to make a decision about possible implementation of a vaccine through their Expanded Program on Immunization.

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