Huge HIV/Aids vaccine trial for SA

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South Africa could be on the verge of a breakthrough in the fight against HIV/Aids as one of the biggest medical trials conducted worldwide is set to begin later this year across 15 sites in the country, according to a Weekend Argus report.

The trial will be similar to the Thai RV114 study conducted in Thailand between 2003-2006. It was also known as the Thai prime-boost Aids vaccine trial with over 16 000 participants but the report says, the South African trial is set to be bigger.

Professor Salim Abdool Karim, director of the Centre for the Aids Programme of Research in South Africa (Caprisa), said the Thai trial showed HIV infections could be reduced by 31%. “The trial data showed the vaccine, which is genetically modified, reduced HIV risk. This was the first time a trial had found evidence that it was possible to reduce the risk of HIV infection with a vaccine. The data from this trial was analysed in detail and Sanofi, the company which made the vaccine, has now teamed up with the National Institutes of Health (NIH) to do a study in South Africa to see if it would work in a South African setting.”

Karim said the trial would involve injecting volunteer participants with the vaccine. “We will talk to patients coming to clinics and inform them about the study and invite them to participate. The people enrolled need to be normal and healthy. They should not have HIV. The vaccine will not work if people have HIV because the vaccine is to prevent it.”

The report said according to Karim there were no risks as the virus was modified and did not contain the HIV genes which endanger the body.

The report says there will be two categories of participants; those who will receive the original modified vaccine and a second group to be given a placebo vaccine. “We won’t know whether a participant was given the vaccine or the placebo. We then do everything in our power to protect the person from getting HIV, but we know that some people will still become HIV positive. After two years we will compare the rate of HIV/Aids with those who received the real vaccine compared to those who had the placebo,” said Karim. “Our goal is we will prevent at least half of the infections,” he said.

According to Karim, once the vaccine was injected into the body it released certain proteins which the body then responded to and created antibodies. The antibodies showed a potential to fight HIV. “We need a vaccine if we are to end the spread of the virus. We don’t think it can end without this. There are many challenges when it comes to making the vaccine which has set the bar high for scientists. HIV is a virus that changes all the time, making it difficult to create a vaccine. There is also no animal model, hence trials can be conducted only on humans. We don’t know what stops HIV and we don’t know what correlates with protection,” he said.

The report says Dr Wilmot James of the Africa Genome Project welcomed the trial and said it showed promising signs of preventing Aids. “A vaccine will bring monumental relief to our overwhelming disease burden. We are getting closer, but not quite there yet. We are greatly indebted to the scientists for their persistence and perseverance and are hopeful the clinical trials will bear fruit. In the meanwhile, we must never let up on safe-sex campaigns, public awareness and education to deal with a disease that is utterly preventable. The moment of the first scientific breakthrough is not the moment to lower our guard and to lapse into complacency,” he said.

Clinical pharmacologist Professor Marc Blockman said the biggest risk linked to the trial was those who participate may face a risk of allergic reaction. “When proteins are injected into the body, you never know how one’s body will respond to them. There is always a risk involved with this,” said Blockman.

The report says the public are being invited to comment or object to the study.

Full Weekend Argus report (subscription needed)

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