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Analysis: How to prepare for an HIV/AIDS vaccine?

lead photo
KATHMANDU, 23 October 2013 (IRIN) - Increased attention to the delivery
of HIV prevention and treatment programmes is needed to prepare
communities for a potential roll-out of a vaccine, which will most
probably be partially-effective, experts say.

"How to deliver a 31 percent effective vaccine - it's hard stuff, it's
uncharted territory, and it's un-costed territory," Mitchell Warren,
executive director of the New York-based NGO AIDS Vaccine Advocacy
Coalition (AVAC), told IRIN.

In 2009 the results from a six-year trial in Thailand of a vaccine
called RV144
showed, for the first time, that a vaccine can provide some protection
against HIV infection
-an-hiv-vaccine> .
Proven to be 31 percent effective, however, it also raised questions
veals-more-clues-about-hiv> about how a partially-effective vaccine
could contribute to HIV prevention.

"I think we have seen modelling potential vaccines take us as far as we
can get until we have more data points about how a vaccine is going to
operate - making concrete some of the assumptions such as efficacy, and
how we would deliver it programmatically," Warren said.

According to the Joint UN Programme on AIDS (UNAIDS
ogy/2012/gr2012/jc2434_worldaidsday_results_en.pdf> ), about 2.5
million people are infected with HIV annually. Developing a vaccine
against HIV has been an elusive goal, since the discovery of the virus
more than three decades ago.

While waiting on a vaccine.

"Vaccines are not part of the 2013 guidelines
from the World Health
Organization (WHO) on [HIV] treatment access because it is not possible
to establish guidelines for products unless they have been qualified
for use. To date there is no vaccine which is considered safe and
effective," a spokesperson for UNAIDS e-mailed IRIN from Geneva, adding
that the agency supports efforts to find such a vaccine.

While it remains unclear when - or if - a vaccine will be approved for
HIV/AIDS, experts agree the success of the roll-out depends largely on
work that must begin now. There are currently 35 ongoing AIDS vaccine

The scale-up of HIV-testing programmes will be crucial, as will close
monitoring of logistical issues surrounding vaccine delivery, they say.

"If we have a vaccine of moderate efficacy, say 50-70 percent, I think
we should still use it. But we must not create a false sense of
security," Michael Merson
director of the Global Health Institute at Duke University in the US
state of North Carolina, told IRIN.

"The conversation we should be having right now definitely should
include a prospective vaccine, but it should be grounded in a
comprehensive understanding of which interventions work best to prevent
HIV in different populations," he said.

Learning from other vaccines

According to WHO, while there are many guidelines on vaccine
implementation, none specifically address partially effective vaccines.
Experts say there are a range of factors that must be considered, and
that some of them are already addressed in public health interventions.

"There are some basic issues about the vaccine that will determine the
specifics of its roll-out," said Duke's Merson. "What are the features
of the vaccine? Are we talking about an oral vaccine? An injectable
vaccine? What age group is it going to be given to? And how often does
it have to be given?" he asked, noting the answers have implications
for cost and public education.

According to Warren, officials can learn from ongoing dissemination of
the human papilloma virus (HPV) vaccine, he said.

"Not only is it a great, highly-effective vaccine, but it also is our
first great example of a vaccine that we need to deliver to young men
and women," Warren said, adding that adolescents will also be a likely
target group for an AIDS vaccine.

Concerns about consent
_report.pdf> , the vaccinated feeling more emboldened to engage in
risky sexual behaviours, and parental resistance to having their
children vaccinated, should not be dismissed, he added.

"Once you make people aware of the vaccine and create the operational
system, you must ensure a supply of vaccine"
"If we focus on the HPV vaccine as the bedrock, whenever we do get the
AIDS vaccine it can be built into what we know from the HPV experience,"
he said, echoing claims by a group of scientists
who examined potential
lessons from other vaccines for HIV.

"The second part is the logistics - the management, the operational
components, the distribution of the vaccine," said Merson.
Moreover, "once you make people aware of the vaccine and create the
operational system, you must ensure a supply of vaccine," he said.

"Failure to do so could create a sense of distrust in the health care
system and discourage the population from taking other vaccines or
seeking health care in general."

Donor community awareness

According to Naresh Pratap Kc, director of Nepal's National Centre for
AIDS and Sexually Transmitted Disease Control (NCASC
), preparing health systems for an HIV
vaccine goes beyond cold chains
delivery issues.

"Countries like Nepal have a strong development infrastructure in terms
of agencies and projects ongoing in-country," Kc told IRIN, saying this
can be a strength or weakness depending on how the agencies' reach and
influence are leveraged.

"Educating people who need the vaccine is part of it, but educating
development agencies about how to work in each country is another part
of it. We can't just assume the agencies know what they're doing with
an AIDS vaccine because they know experiences in another country or for
another vaccine," he said, reinforcing the UNAIDS and WHO call, first
made in 2002
_report.pdf> , but still relevant now, to educate policy-makers with
accurate scientific facts about an HIV vaccine as early as possible in
the roll-out process.

HIV testing

While waiting on a vaccine, there are other proven prevention methods,
activists emphasize.

Photo: Keishamaza Rukikaire/IRIN
HIV testing key, vaccine or not
"We need to not wait until we have a vaccine. It is not magic. It's not
going to appear in people's arms because they're at risk of HIV,"
Warren told IRIN.

"Some people say a vaccine is the only way to end the epidemic. A
vaccine doesn't end an epidemic if people don't come in to get tested,
so there are a series of issues we need to overcome now," he said.

Modelling of a
partially-effective HIV vaccine at 30 percent and 60 percent coverage
of the men who have sex with men (MSM) in one part of Australia showed
modest results, reducing incidence rate (newly diagnosed cases) by a
maximum of 23 percent over 10 years. The authors recommended in 2011
that a partially-effective vaccine be "supplemented with other
biomedical and educational strategies".

But research published in 2008

also warned that uptake of standard vaccines (including measles, mumps,
and rubella) among populations most affected by HIV in the US was among
the lowest nationwide, suggesting it may be difficult to encourage
vaccination among the people who most need it, given the stigma of
people infected with HIV.

According to experts, this challenge highlights the need for better
delivery methods, a scale-up current successful interventions, and
improving what Warren calls "the science of delivery".

"To think about delivery the day after a product is proven is too late,"
Warren told IRIN.

"To think about delivery the day after a product is proven is too late"
According to UNAIDS and WHO
_report.pdf> , the efficacy of a first generation HIV vaccine may be
moderate. However the overall public health efficacy may be higher when
combined with other forms of prevention.

Warren agreed that the silos of HIV prevention must be broken.

"It's not vaccine, or PrEP
prep> , or microbicide - it's vaccine and PrEP and microbicide and
combination prevention and understanding where prevention fits in with
treatment," said Warren referring to pre-exposure prophylaxis, the use
of antiretroviral drugs by HIV-negative people to reduce the risk of
their acquiring HIV, and microbicides
o-reality> , vaginal and anal gels containing anti-retroviral drugs.

Community outreach

"If there is a vaccine that works, say, 60 or 70 percent, I think we
would be comfortable with it once it got all the international
approval," said Kc of Nepal's NCASC. "But I would ask the key affected
populations their views on implementation design first."

Many HIV prevention
-comfort-zone> advocates agree, saying that communities who carry the
heaviest burden of HIV risk and infection should be at the core of
policy and programme delivery decisions.

Economic projections
ted> have shown that focusing on "key affected populations", including
MSM, people who inject drugs, and sex workers, can be cost-effective,
an important consideration given dwindling HIV/AIDS funding
lobal-fund-not-enough> .
And given how much efficacy depends on how much of the population is
vaccinated (and who), experts stress the importance of "social research
investigating the likely
acceptance and response of the introduction of a partially-effective


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