South Africa approves its first HIV vaccine trials
In June 2003 the South African Medicines Control Council (MCC) approved South Africa’s first HIV vaccine trial (called HVTN 040). This trial will test an experimental vaccine known as AVX101, developed by AlphaVax in the US. HVTN 040 will be conducted by US and South African scientists in the US HIV Vaccine Trials Network (HVTN).
In August the MCC approved a second trial. This trial will use a vaccine known as HIVA.MVA that was designed by scientists at the University of Nairobi (Kenya) and the University of Oxford (UK). The study will be conducted by an international team sponsored by the International AIDS Vaccine Initiative (IAVI).
The AVX101 and HIVA.MVA trials are separate, but they will be conducted at the same South African sites: one in Soweto and the other in Durban. HVTN 040 will enroll a total of 96 volunteers in South Africa and the US and will study three different doses of the vaccine to look for safety and immune responses. Testing will begin in the US and proceed in South Africa once safety is established.
The IAVI-sponsored trial of HIVA.MVA is planned to take place at sites in South Africa and Europe and will enroll a total of 111 volunteers—including approximately 50 South Africans. The vaccine used in this trial is also being studied in Kenya, Uganda and the UK.
Each trial will test a different delivery system, or vector, for carrying very small portions of HIV. None of these fragments can cause HIV. The two trials use vaccines based on different HIV subtypes, or clades (see Primer). HIVA.MVA is based on clade A which is common in east Africa. AVX101 is based on clade C which is most common in South Africa.
Both trials are scheduled to start in late 2003. South Africa joins three other African countries—Uganda, Kenya and Botswana—which have started trials or approved them this year.