The International AIDS Vaccine Initiative (IAVI), which undertakes research for a preventive AIDS vaccine, has commenced phase II clinical trials for a preventive AIDS vaccine. Modified Vaccinia Ankara (MVA) - TBC-M4, which is targeting HIV-1 subtype C, is currently undergoing trials at the Tuberculosis Research Centre (TRC), Chennai. The trial began in January 2007 and will be completed in Q1, 2008.

Recently, IAVI has conducted country's first clinical trial of a preventive AIDS vaccine candidate at the National AIDS Research Institute, Pune to test the safety and immunogenicity of the Adeno Associated Virus (AAV) vaccine.

Seth Berkley, CEO and president, said, "IAVI has successfully conducted two phase-I clinical trials in the country. The preliminary results shows that, the vaccine is safe, well tolerated and induces a good immune response. These preliminary results are encouraging. The preliminary results of the MVA trial should be presented in August 07 at the AIDS Vaccine Conference in Seattle."

In the phase II trial, 32 healthy volunteers have been enrolled and will be followed up for 12 months post-vaccination. The volunteers enrolled in phase I trials are healthy and not infected with HIV.

While talking about biotech tie up with Indian companies, he said, that IAVI has not entered into any tie up with any biotech company in India. The first component of the Indian Medicinal Chemistry program, co-sponsored and co-funded by IAVI and the Department of Biotechnology to design vaccines that elicit neutralizing antibody responses against HIV infection, will comprise principal investigators from different academic research laboratories working under a common research agreement.

"The initial investigators will include Professor Virander S Chauhan of the International Centre for Genetic Engineering and Biotechnology, New Delhi; Professor Raghavan Varadarajan of the Indian Institute of Science, Bangalore; Dr Stephen Kaminsky of IAVI's AIDS vaccine development laboratory, New York, and Dr Philip Dawson of The Scripps Research Institute, California. At a later stage, based on their initial research and vaccine design concepts, both partners expect to work with an Indian manufacturer to assist with high throughput synthesis, antigen chemical characterization and potency evaluation of proposed AIDS vaccine candidates, he further added.

When Pharmabiz asked about expansion plan, Seth commented that, while the launch of the phase I clinical trial of a preventive AIDS vaccine candidate (tgAAC09 or AAV) at NARI and the second phase I trial of a vaccine candidate TBC-M4 (MVA) at TRC, Chennai, are significant moments for India, several such phase I trials may need to be considered before more promising candidates move to phase II and phase III trials.

Decisions to proceed to further steps are guided by the safety and immunogenicity data generated in pre-clinical studies as well as in phase I clinical trials in India and in other countries.