NARI- National Aids Research Institute is all set to undertake Phase I clinical trials for the HIV Subtype-C preventive vaccine, termed as Indian HIV vaccine, by next year. The vaccine is being developed by National Institute of Cholera and Enteric Diseases (NICED), Kolkata, in collaboration with the US based Therion Biologics, using Modified Vaccinia Ankara (MVA).
Dwelling on the objectives of the trials, Dr. S. Paranjape, deputy director, NARI said, "The candidate vaccine is undergoing animal toxicity and immunogenicity studies at US based contract research organisation. Once the results are available, regulatory clearances will be obtained. The trial will commence once all clearances are obtained." After the clearances, NARI would conduct Phase I trial in normal healthy adults to study the safety and tolerability and immunogenicity of the test vaccine. The trial may start in second quarter of 2004, informed Dr. Paranjape.
The trials, supported by International AIDS Vaccine Initiative (IAVI) and Indian Council of Medical Research (ICMR), would witness the participation of thirty-nine volunteers. The enrolment for the trials would commence in second quarter of the year 2004.
For NARI the biggest challenge would be to get diverse volunteers, which according to Dr. Paranjape would not be easy due to fear of stigma and side effects, and of acquiring the disease. Yet NARI is gearing up to ensure the success of the trials, averred Dr. Paranjape, "A community preparedness plan is being implemented to ensure adequate participation of the volunteers. A volunteer recruitment plan is being finalized. Besides the staff of the Institute, some new staff is being recruited and trained for the trial. A new clinic and laboratory facility dedicated to the trial is getting ready."