CHENNAI: India's HIV vaccine programme got a major boost with scientists of the Tuberculosis Research Centre (TRC) here reporting significant progress in the first phase of clinical trials for a vaccine to prevent AIDS.
Preliminary results of phase one trial have successfully proved the vaccine's safety and its ability to stimulate immune response (that might provide protection against infection), the centre's head told TOI.
Confirming the development, TRC director V D Ramanathan said: "The trial was to check the vaccine’s safety and also whether it fulfilled the secondary objective of stimulating immune response. We will announce the results to the world soon after we have the complete analysis of the data."
TRC is affiliated to the Indian Council of Medical Research (ICMR), which, along with National AIDS Control Organisation (NACO) and the International AIDS Vaccine Initiative (IAVI), has spearheaded the vaccine trial in India.
"The Phase I trial of an MVA-based AIDS vaccine candidate (TBC - M4) was conducted at the TRC in Chennai. The preliminary results of the trial showed that the vaccine candidate was generally safe and well tolerated and the frequency of immune responses by volunteers after three injections was good. The phase I trial is over and the final data is under analysis," said Dr Sonali Kochar, Medical Director, IAVI India.
The initial success of the trial with the MVA (Modified Vacinia Anacara)-based vaccine candidate (TBC-M4) comes in the wake of National AIDS Research Institute (NARI) in Pune winding up research with another vaccine candidate AAV (Adena-Associated Virus).
The Pune institute's trials ended in December 2007, after tests in two other countries, Germany and Belgium, with the same vaccine candidate failed.
The vaccine being tested in Chennai has been designed by a Kolkata-based ICMR scientist. To date, there have been at least nine MVA vaccine candidates that have been tested or are still currently in testing in labs around the world.
Controversy clouded the Pune project with reports that the trial conducted on 30 healthy volunteers continued for a year despite scientists learning even within a fortnight that the AAV vaccine had failed in tests in Germany and Belgium.
The Union government and the IAVI had signed an agreement to conduct the HIV vaccine trials both in Chennai's TRC and Pune's NARI. But, with the Pune trials being stopped, the Chennai project is India's only hope for a HIV vaccine.
The phase one trial of the vaccine at TRC, which began in January 2006, was conducted on about 30 healthy, HIV negative volunteers. "The prime objective was to check its safety which we have tested successfully. The secondary objective
of checking its ability to stimulate an immune response has also been tested," said Dr Ramanathan, whose team has been tirelessly working on the vaccine, which could provide a key preventive weapon in India’s war against AIDS.
In phase II of the trial, the vaccine will be tested on a larger number of volunteers, about 300 men and women. The objective of the phase II trial is to double-check the safety of the vaccine, its immune response and the dosage to be administered. It will take about four years for this phase to be completed and another eight years for phase III, during which about 3,000 volunteers, drawn from low and high risk groups, would be tested.
According to Dr Kochar, there are approximately 30 AIDS vaccine candidates in the clinical pipeline in various stages of testing today. One of these candidates is being tested in a phase III trial in Thailand, the third AIDS vaccine candidate to reach efficacy testing to date.