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HIV/AIDS vaccine trials only weeks away
Liz Clarke. 21 June 2003. The Independent on Saturday. Republished courtesy of Independent Newspapers (Pty) Ltd.
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The first volunteers in South Africa's historic human clinical trial for a phase one HIV vaccine could receive initial doses of vaccine substance within the next 10 weeks.
This follows the approval by the South African Medicines Control Council, which has given the green light for the first trial of cutting-edge HIV candidate vaccine technology in humans and the first human trial targeting the clade C virus in SA.
The technology, developed by scientists in South Africa, uses virus like particles, containing parts of an attenuated strain of Venezuelan equine encephalitis (VEE) virus and a gene from a South African strain of HIV to deliver the vaccine to the immune system.
Dr Andrew Robinson, head of the South African AIDS Vaccine Initiative (SAAVI) research unit in Durban, said "a very exciting chapter" in the fight against the HIV/AIDS scourge was about to start.
We have reached the stage when we can talk about definite dates for the start of the trial," he said. "We have volunteers, but we do need more."
The initial safety phase of the trial is being conducted on a parallel basis between research sites in America and South Africa, with the first American participants receiving the vaccine substance next month.
Once safety data has been analysed from the first 12 members of the American trial cohort - and no significant side effects recorded - South Africa will start the same trial, with the exact dose given to the first 12 volunteers.
The US/South African trial will then continue on the same alternate process, with each successive cohort receiving increased doses until the maximum dosage is achieved. The entire safety process should be completed within a year. In South Africa 24 volunteers will be enrolled in Durban and 24 in Johannesburg.
The three requirements for volunteers are to be in good health, HIV-negative and able to give informed consent.
The two South African sites are at the SAAVI Vaccine Research Unit at the Medical Research Council in Durban and the peri-natal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto. |
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