17 volunteers from Pune ready to test AIDS vaccine

[Guest guest]

17 volunteers from Pune ready to test AIDS vaccine Phase-I Trials :

In all, 30 un-infected people required; with all approvals in place,

now NARI gets ready for the big challenge. Anuradha Mascarenhas

Pune, January 12: That the country's most challenging trial on humans

in search for that elusive AIDS vaccine will start soon in Pune - a

month-and-a-half from now - is an established fact. But just who are

these volunteers who have selflessly dedicated themselves to the

mission of wiping out this disease?

Of the 700 who were interviewed, 50 made it to the second round of

talks and discussions with National AIDS Research Institute (NARI).

Finally, 17, including 10 women, have evinced keen interest in the

first ever preventive HIV/AIDS vaccine trial to halt the march of the

epidemic.

According to Dr Sanjay Mehendale, Deputy Director, NARI and principal

investigator of the trial, in all, 30 volunteers are required to be

enrolled for the trial. The present lot is from Pune and hail from all

strata of society — some are cooperative housing societies members,

nurses, health care workers and family members of AIDS-affected victims.

``So far there has been a mixed response from religious leaders,'' he

said adding that most decided to volunteer solely due to altruistic

motives - ``wanting to do something for society''.

At a day-long media workshop here on Wednesday, representatives of the

International AIDS Vaccine Initiative (IAVI) and NARI made detailed

presentations on the preparations for the trial in India, medical

insurance for volunteers and even appointing Reliance Clinical

Research Services to monitor the trial at NARI.

Louis Excler, Medical Director, IAVI explained that the trial

will be conducted in HIV-uninfected healthy volunteers (men and women

in the age-group of 18-50 years) at low risk of contracting the HIV

infection. Dr Ramesh Paranjape, officer-in-charge of NARI, also spoke

about how qualitative research studies were conducted to examine the

willingness of volunteers to participate in the trial.

The volunteers are required to sign informed consent forms and will be

reimbursed transportation and loss of wages up to Rs 500 per scheduled

visit. The IAVI's general policy regarding quality of care for

volunteers include free anti-retroviral drugs for a period of five

years in case they contract the HIV infection — not because of the

vaccine — but due to their high risk behaviour. They will also get

medical insurance during the trial for vaccine unrelated medical

events too.

The road to the vaccine trials has been a long one. The government via

the Indian Council of Medical Research and the National AIDS Control

Organisation under the Ministry of Health and Family Welfare signed an

MoU with IAVI to accelerate efforts to develop a safe and effective

AIDS vaccine for use in India. The search is on for a vaccine that

would counter HIV-1 subtype C, the most common HIV strain in India.

Two centres of excellence for the AIDS vaccine clinical evaluation

have been set up — one is in Chennai and the other is here at NARI

where IAVI is working towards conducting the phase 1 clinical trial

with the Adeno-Associated virus (AAV)-based vaccine. All the

approvals, including scientific, regulatory and ethical, are in place,

said Dr Sanjay Mehendale, Principal Investigator of the trial and

Deputy Director NARI.

Globally, multi-centric trials are also underway in Belgium and

Germany who have enrolled 50 volunteers since February 2004 and so far

there has been no vaccine related adverse events, Mehendale added.

http://cities.expressindia.com/fullstory.php?newsid=113810