Speaking at the XIIIth World AIDS Conference in Durban last month, Oxford University immunologist, Andrew McMichael announced the approval for human testing of a DNA/modified vaccinia virus prime boost HIV vaccine he is developing in conjunction with the University of Nairobi in Kenya.
A Phase I safety trial of the gag DNA component of the vaccine will begin this month with 18 volunteers in Oxford—one of which is the Member of Parliament for Oxford, Evan Harris. Testing of the vaccinia boost unit will start next month, combination testing is slated for October, and trials in Kenya are expected to begin by the end of the year. The trial is supported by the International AIDS Vaccine Initiative (IAVI).
Meanwhile, South Africa's effort to develop its own HIV vaccine will be put to the test early next year. The South African AIDS Vaccine Initiative (SAAVI) has announced that it will begin human trials of its Venezuelan equine encephalitis (VEE) virus vaccine in Kwazulu-Natal in January 2001, provided permission is granted by the South African Medicines Control Council (MCC) in October. The president of the South African Medical Research Council, William Makgoba, told Nature Medicine that SAAVI aims to complete Phase III trials by 2005. Development of the VEE vaccine is supported by IAVI and by North Carolina based, Alphavax (Nature Med. 5, 1220; 1999).
The effort to develop a South African vaccine will be aided by R100 million (US$ 14.7 million) over a five-year period awarded to the MRC last month by the US National Institutes of Health. R10 million of the funding will be used to establish a vaccine trial unit and R6 million will go to the creation of an HIV prevention unit that aims to test microbicides and the effectiveness of nevirapine in preventing HIV transmission through breast feeding. The grants are the largest to be given to a South African research organization.
SAAVI has seven other vaccines in the pipeline, including a DNA construct candidate developed at the University of Stellenbosch and with California-based Chiron Corporation, which is also nearing Phase I trials; plus BCG vector, MVA vector, naked DNA and edible (plant) vaccines being developed at the University of Cape Town.
The challenges that developing countries face in trying to produce their own HIV vaccine were discussed at the Durban AIDS meeting. Roy Widdus of the independent Swiss foundation, Global Forum for Health Research, a principal author of IAVI's blueprint, “AIDS vaccines for the World: Preparing Now to Assure Access” admits that there are pitifully few institutions capable of producing quality vaccines outside developed nations but calls for their involvement to be maintained because of the high volume of vaccine that might be needed to immunize against HIV worldwide.
Helen Rees, chair of the MCC, discussed the worldwide attention that the first trial of a home-grown vaccine in her country will attract: “AIDS is sensitive terrain. Vaccine testing will involve trials on poor black people, run by white organizers. The clinical schedule must be solid and defensible.” Rees also revealed that her agency has been in discussions with the US Food and Drug Administration via the head of the White House AIDS unit, Sandra Thurman, regarding special regulations to facilitate the development of an HIV vaccine.
The first trial of an HIV vaccine began in Africa last year. The HIVNET007 study is sponsored by the US National Institutes of Health and is testing a canarypox vaccine in 40 HIV negative Ugandans.
About this article
Cite this article
Birmingham, K. HIV vaccine trials planned for Africa. Nat Med 6, 844 (2000). https://doi.org/10.1038/78569