Challenges in HIV/AIDS vaccine research
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Source:
Integrated Regional Information Network <IRIN@irinnews.org>
CAPE TOWN, 5 June (PLUSNEWS) - Despite optimism about the development
of an HIV/AIDS vaccine in Africa, researchers still face many hur-
dles, scientists said this week at the launch of the African AIDS
Vaccine Programme (AAVP).
Dr Pontiano Kaleebu, a leading researcher with the AAVP and the
Uganda Virus Research Institute, said at the launch of the AAVP in
Cape Town, South Africa, that only two phase one trials had been com-
pleted in Africa to date.
There are three phases in human clinical trials. Phase-one involves
20-60 healthy, uninfected volunteers at low risk of HIV infection,
and tests for safety.
He said the lack of research was "partly a consequence of neglect and
partly of slow and complex decision-making". Some African nations re-
quired the consensus of many officials at every level of government
before a clinical trial can begin.
There is a growing consensus that an AIDS vaccine is the best long-
term hope to control the AIDS epidemic, especially in developing
countries.
"A vaccine for Africa would be the best long-term preventive measure
against AIDS... this initiative, could help address the health and
development tragedy that AIDS has become for many African countries,"
Peter Piot, Executive Director of UNAIDS said in a statement last
week.
But the regulatory process in most African countries is slow, unpre-
dictable, and sometimes non-existent, as guidelines for such research
have not been defined yet. In Uganda, it took two years and 9 commit-
tees to approve the vaccine trials conducted there, as there were no
set procedures, Kaleebu noted.
Ethical and legal requirements, such as obtaining informed consent
for volunteers to participate in the trials were not as straightfor-
ward in Africa as there were cultural issues involved. In many Afri-
can cultures, women need permission from their spouses and cannot
give individual consent.
Researchers also had to assess whether trial participants adequately
understood the purpose of the trials, particularly in rural settings.
In Uganda, compensation for the treatment of research-related inju-
ries during the clinical trials had led to many participants taking
advantage of this, undermining the whole process, Kaleebu said.
Effective family planning was important, as the risks of the candi-
date vaccines to the foetus were still unknown, he added.
Developing a physical infrastructure of clinics, laboratories and
state-of-the-art technology was particularly difficult in areas where
basic utilities such as power and water were not easily available.
The conflict between creating a therapeutic or preventive vaccine was
a "difficult issue" as those already living with HIV/AIDS also wanted
a vaccine, he said.
"Many Africans are skeptical about trials as they believe they are
being used as guinea pigs by the developed countries," he told Plus-
News.
According to Kaleebu, these challenges did not mean there was no fu-
ture for vaccine trials in Africa, as Africa was gaining momentum in
its research. There were a number of trials lined up in South Africa,
Nigeria, Cote D'Ivoire and Ethiopia and other countries, he said.
AAVP chairman Dr Malegapuru Makgoba told journalists that the first
phase-one effectiveness trials on a candidate vaccine for HIV sub-
type C - the variant prevalent in southern Africa - could start in
South Africa soon, and was only awaiting regulatory approval.
However, this process could not be rushed. "You need high ethical
standards... we have to be sure that the day we start injecting we
are not going to be facing the consequences of destroying the whole
process," he said.
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