SA Aids vaccine gets the green light
September 26 2002 at 08:45PM
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| By Liz Clarke |
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The green light has been given for the manufacture of three potential
Aids vaccines.
If they are safe and effective, they will bring the first glimmer of hope to
a country devastated by the Aids pandemic.
The fast-track life-and-death process has been been given a significant
multimillion-rand boost after tests by some of the country's top scientists
produced "promising data" during laboratory trials.
According to a South African Aids Vaccine Initiative (SAAVI) spokesperson,
the vaccines will enter the manufacturing process and safety-testing phase
as soon as possible.
| The three vaccine products incorporate the
genetic sequences of South African strains of HIV |
Facilities in Britain and the United States,
which can produce the products in a manner suitable for initial human
clinical trials, are already being considered.
If the resultant vaccines are approved by United Kingdom's Medical Control
Council and the US Food and Drug Administration, it could hold good
prospects for a similar manufacturing process in South Africa.
At an Aids vaccine conference held in Cape Town, the financial backing for
the ground-breaking South African initiative was spelled out, with initial
contributions amounting to R70-million.
The three candidate HIV vaccine products incorporate the genetic sequences
of the South African strains of HIV (subtype C), the most prevalent strain
in the region.
The scaled-up manufacturing process is extremely expensive, time consuming
and technical. It involves bulk manufacturing, toxicity analyses to ensure
product safety before human testing, and a rigorous documentation process
for submission to regulatory authorities.
"We need to proceed as rapidly as possible to phase-one human clinical
trials to test whether these candidate vaccines, and other promising
candidate vaccines, are safe and of potential clinical benefit in preventing
HIV infection or disease," says SAAVI director Dr Tim Tucker.
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