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22 Jan 2008 10:30
Researchers from the University of Cape Town (UCT) have developed two test HIV vaccines—the first wholly South African-developed products to enter the human clinical-trials phase, the Herald Online reported on Tuesday.
The vaccines are just months away from being assessed in human clinical trials, the Herald said.
One of the vaccines, Saavi MVA-C, is a genetically modified organism. The other, Saavi DNA-C2, is not.
Advertisements in weekend newspapers explained the vaccines’ purpose and the objectives of the proposed clinical trials.
Interested parties now have 30 days to submit comments or objections to the Department of Agriculture and Land Affairs’s registrar: genetically modified organisms, the Herald said.
Both that body’s review committee and the Medical Controls Council (MCC) will have to approve the application before human trials can commence, the Herald said.
Glenda Gray of the Perinatal HIV Research Unit at Johannesburg’s Chris Hani-Baragwanath Hospital—the protocol chair for phase one of the clinical trials—told the Herald she hoped the trials would be approved within three months.
Both vaccines had already been tested on mice, rabbits, baboons and rhesus macaques, said Gray.
Phase one of the proposed clinical trials would involve 36 people at two sites, one in Cape Town and one in Gauteng, and 12 people in the United States, Gray said.
The South African Aids Vaccine Initiative (Saavi) began funding the vaccine development project at UCT in 2000, said Anna-Lise Williamson, a joint staff member of UCT and the National Health Laboratory Service.
The project was partly funded by the national departments of science and technology and health, as well as Eskom and the National Institutes of Health in the United States.
The American leg of the trials had already been approved by that country’s Food and Drug Administration, said Linda-Gail Bekker of UCT’s Institute of Infectious Diseases and Molecular Medicine.
Gray said the group’s application to perform clinical trials had been submitted to the MCC on Friday.
Phase one of the trials would test “tolerability”—how well humans handled particular doses of the vaccine.
Clinicians would then study the vaccines’ impact on participants’ immune systems.
This phase would be undertaken using “low-risk” participants who did not engage in risky sexual behaviour or intravenous drug use, said Gray.
The vaccines were specifically designed to target the strain of HIV-1—subtype C—that accounts for the majority of HIV infections in Southern Africa, said Bekker.
Saavi’s Michelle Galloway said while the organisation was pleased with progress in developing the uniquely South African vaccines, there was “still a long way to go” before scientists would know whether the vaccines would be “in any way successful in preventing HIV infection”, the Herald said.—Sapa
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