Thirty Pune residents between 18 to 50 years, their identities guarded from the world, will soon walk back into their regular lives after taking a shot in the arm in India’s first human trial to test a vaccine against HIV/AIDS. The first results are now just a few months away.
Around January 3, these healthy, HIV-uninfected participants will go for one last visit to the Pune-based National Aids Research Institute (NARI) where the trial began last year.
The vaccine is modelled after HIV subtype C that accounts for most infections worldwide including India, with 5.7 million living with HIV/AIDS. The vaccine does not contain the HIV virus, so volunteers are not at risk of infection. But the search for 30 literate, medically eligible people in the city of three million was a trial in itself.
The group of 53 per cent men and 47 per cent women was slowly formed after reaching out to 8,000 people, until 80 agreed to be screened and 30 were selected. “It was not at all easy to get volunteers for the study,’’ Sanjay Mehendale, NARI deputy director and the trial’s principal investigator told the Hindustan Times. “For most volunteers the reason to participate was altruism. They are from all strata of society, including professionals. All expressed a desire to do something good for society.’’
NARI needed a year before the trial to find participants through website awareness and community meetings. The trial—simultaneous with 50 volunteers in Belgium and Germany — will evaluate the vaccine’s safety and ability to generate an immune response in HIV-uninfected, healthy volunteers who take an intramuscular arm injection.
The volunteers were split into three groups for low, medium or high dosage. In each group of 10 volunteers, eight received the vaccine and two received a placebo with no active ingredient. But until the trial ends in January, even the researchers will not know which participant received which shot. “After the last visit, the data will be analysed over three months, separately and together for participants in India and Europe,’’ said Mehendale. “The decision to plan further clinical trials will be taken after this analysis.’’
The volunteers were reimbursed only travel expenses and loss of daily wages during visits to NARI for monitoring and tests. They faced the prospect of an unexpected side effect, although the vaccine — tgAACO9 — has been tested on animals. The NARI website cautions that since the effect the vaccine might have on an unborn child is unknown, women participants had to use contraception until four months after the injection. They were advised to avoid any risk of contracting HIV.
But there are 30 AIDS vaccine trials ongoing in 19 nations, and when a vaccine will be available in India is “difficult to predict”. This small-scale trial is for a vaccine designed by Seattle-based Targeted Genetics and Columbus Children’s Research Institute in Ohio, USA, with the International AIDS Vaccine Initiative.
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