Durban - As the country celebrates World Aids Day today, two Inanda residents took a bold step to be the first in the province to participate in the HIV Vaccine Trials Network (HVTN 702) study to find a cure for HIV/Aids.
Ningi Mbutho, 29, and Nkosinathi Mncube, 23, said they were proud to participate in this trial.
The two received their first injections on Wednesday at the KZN launch of the major study to test the efficacy of the vaccine to prevent HIV infection at the Medical Research Council (MRC) site in Verulam.
Mbutho, a mother of three children, said she knew about the site for two years, but only learnt about the current initiative about a few months ago.
“When I talked to people about this initiative, some were sceptical. I thought about young people, my children and what I understand about HIV/Aids, and thought this is one thing I’m not going to miss. I’m HIV negative, but it’s not about me. It’s about how everyone will benefit once this trial becomes a success,” she said.
What makes her brave, she said, is the explanation and counselling provided to volunteers.
“I thought about the risks but once everything was explained and also warned about bad sexual behaviour and the precautionary measures in place, it gave me the spirit to participate. At home they know about what I’m involved with. In the end this will be for the benefit of the community, society and the country at large if the trial becomes a success. I’m not scared, in fact if I was, I wouldn’t be participating,” she said.
After taking his dose, Mncube also said he “felt great” that he was part of the trial.
“I may be healthy, but how many are not?”.
“I’m feeling good about this,” he said when quizzed after the injection was administered.
The HVTN 702 would establish whether this experimental vaccine regiment safely prevents HIV infection among South African adults.
It involves a new version of the only HIV vaccine candidate yet shown to provide some protection against the virus and aims to enrol 5 400 HIV negative men and women.
The participants in the trial, aged between 18 and 35, were screened and counselled on HIV prevention before they were admitted.
Blood and pregnancy tests were conducted on the women, said Professor Gita Ramjee during a question and answer session with the media.
“Over the study period, we will see how many participants were infected with HIV within the vaccine and the placebo groups. We do a statistical analysis to determine the outcome of the trial,” said Professor Ramjee.
She said participants were also given a package of prevention options.
“Remember, not everyone can negotiate safe sex, so with the prevention package we hope to prevent infection,” she said.
The results of the trial are expected to be available in 2020.
The vaccine has some “minor” side-effects such as nausea and skin rash, but participants are in contact with the research team to register any side effects.
This initiative is the largest and most advanced HIV vaccine clinical trial to take place in South Africa.
“If an HIV vaccine were to work in SA, it could dramatically alter the course of the epidemic,” said Professor Glenda Gray, president of the Medical Research Council of SA.
“Half the participants get the vaccine and half get control and we tell everybody to protect themselves. What we are evaluating is how this vaccine works with the standard of prevention we have versus the standard of prevention by itself,” said Professor Gray.
The experimental vaccine regimen being tested in HVTN702 is based on the one investigated in the RV 144 clinical trial in Thailand led by the US Military HIV Research Programme and the Thai Ministry of Health. The Thai trial delivered landmark results in 2009 and the experimental vaccine regimen it tested was found to be 31.2% effective in preventing HIV infection over the 42 months follow-up period after the vaccination.
In the HVTN 702 study, the design, schedule and components of the RV 144 vaccine regimen have been modified in an attempt to increase the magnitude and duration of the protective immune responses elicited by the vaccine.
“This launch represents a significant HIV prevention milestone. In earlier studies, this vaccine regimen improved on many of the antibody responses to the type of HIV strains circulating in SA, providing us the scientific basis to conduct this pivotal trial. This study will provide important insights into vaccine development to help prevent new infections and end the epidemic,” according to a statement by Dr Larry Corey of the HVTN.
The study is conducted at 15 research centres in the country.
The volunteers are randomly assigned to receive either the investigational vaccine regimen or the placebo. All study participants will receive injections on five occasions over the course of one year.