Stringent global standards to enlist participants are slowing the process of volunteering to participate in South Africa’s ground-breaking HIV vaccine trial, known as HVTN 702 but News24 reports that despite the administrative snag, the vaccine trials have been continuing. They have attracted about 500 volunteers who have signed up in 15 operational sites across South Africa, according to the Vaccine Advocacy Resource Group. This figure is just 10% of the intended number of participants.
The report says the HVTN 702 trial was launched on 1 December 1 last year and is expected to enlist 5 400 participants of which 60% should be women and 40% men aged 18 to 35. It is aimed at determining if a new HIV HVTN 702 vaccine regimen is safe, tolerable and effective in the long run in preventing HIV infection among South African adults. The group said this figure was not as small as it seemed considering the stringent processes that had to be followed before a participant is enrolled.
The group’s Tian Johnson said researchers have to ensure that an individual is properly confirmed as eligible to participate in the trial. Researchers are also obliged to make sure that participants understand the safety requirements and give their consent, he said.
“Before the trial starts, there needs to be a community advisory board and stakeholder meetings, getting ethics approvals and training staff at the site on the safe implementation of the study. The recruitment team then identifies participants and they have discussion groups where more information is given to them about the trial.”
The participants are assessed on how much understanding they have about the trials and whether they were properly informed when they signed consent forms. Once that is done, they undergo physical tests including blood tests for HIV, urine tests for urinalysis and pregnancy, and other eligibility assessments, he explained.
During the trials, participants will receive five injections over the course of 24 months and will be monitored for another three years to establish whether the vaccine elicits a sustained protective effect. If the HVTN 702 vaccine shows positive results that lead to its being licensed by the Medicines Control Council, it would mean that thousands of new infections could be averted in future.
The report says the latest statistics from UNAIDS showed that 7m people in South Africa lived with the virus last year. About 180 000 of those had died of Aids-related illnesses, while 380 000 people had been newly infected.
Johnson said the goal was to enlist healthy people so that the efficacy of the vaccine could be tested. “Researchers don’t want a situation where the vaccine will affect any disease progression or any disease that may affect their immune response to the vaccine,” he said.
Johnson mentioned that the duration of the trial might also be contributing to the slow enrolment process. He explained that participants have to be monitored for three years.
“Three years is a long time. Some people don’t even know what they are doing past this year,” he said.
Ntando Yola, an advocate at Vaccine Advocacy Resource Group also emphasised this point, adding in the report that as part of community engagement, ethics have to be considered to ensure that people understand what they are committing to. “The constant challenge is to balance between meeting recruitment and enrolment deadlines, and at the same time ensuring the integrity of the trial while safeguarding the rights of participants. It’s important for the community to understand and be clear about what it means to participate in a vaccine trial,” Yola said.News24 report