Durban - One of the biggest medical trials to be conducted in South Africa is set to begin in 10 days, and if successful the world will be a step closer to a vaccine for HIV.
The HVTN 702 study will take place across 15 sites in the country, including three sites in Durban and one in Ladysmith. It will be similar to the Thai RV144 study in Thailand from 2003 to 2006, which had more than 16 000 participants.
The first participants will be injected on November 30.
The trial is a large, advanced-stage vaccine study testing whether a combination of two vaccine candidates can prevent HIV infection in adults.
The study has already started enrolling the first of its 5 400 participants aged 18 to 35.
They need to be HIV-negative women and men who are in good health and from diverse communities. Women should be willing to use an effective birth control method throughout the study.
Due to the generalised nature of the country’s HIV epidemic, most of the communities are at risk, particularly people in the 18 to 25 age group.
Durban researcher Professor Gita Ramjee, who is actively involved in the trial, said the study vaccines cannot cause HIV infection or Aids as they do not contain the HIV virus.
“Half the participants in HVTN 702 will receive the vaccine candidates and the other half will receive half a placebo (an injection without any study vaccine in it). Neither the participants nor the study team will know who has received which type of injection until the end of the study,” she said.
The participants will get five injections over one year, and will then be followed-up for another two years to assess how the immune response is sustained over this period.
“This process is now at the start. To date, four of the 15 sites have started to receive volunteers and screen them as potential participants. In KZN, we have so far initiated two sites. There are over 40 volunteers who have enrolled in KZN,” said Ramjee here.
Once the trial is over, the data obtained is analysed to ascertain whether the vaccine was safe and if it prevented HIV infection among participants who received the vaccine compared to those who received the placebo.
“If the data is robust, the regulators will assess if the vaccine is good enough for introduction in the community to prevent HIV infection. The process is long as the results will determine the next steps once the trial is concluded,” said Ramjee.
She said it was a pivotal study because it was designed to provide answers in respect of safety and efficacy that could lead to a licensed HIV vaccine in South Africa.
In terms of the risk, Ramjee said that science and medical research were never risk-free.
“The trial is strictly controlled by regulatory bodies appointed by government and by ethics committees and independent experts to ensure the safety of participants.”
She said participants were told the study vaccines could, in rare cases, cause a reaction such as increased body temperature, nausea or a rash, and they were counselled on what to do should this happen.
“These are common reactions for many widely used vaccines,” she said.
Sunday Tribune