The Vaccine Advocacy Resource Group would have liked to see many
South Africans volunteer to participate in the country’s ground-breaking
HIV vaccine trial, known as HVTN 702, but stringent global standards to
enlist participants are slowing the process.
However, 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.
This figure is just 10% of the intended
number of participants. The HVTN 702 trial was launched on December 1
last year. It 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.
Tian
Johnson of the Vaccine Advocacy Resource Group 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 latest statistics from
UNAIDS showed that 7 million 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 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.
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