Indian Council of Medical Research (ICMR) and International AIDS Vaccine Initiative are now gearing up to carry out the phase-I study of a combination vaccine for Human Immunodeficiency Virus (HIV) in the country. The combination vaccine is ADAX and TBC-M4. The trials will be undertaken at the National AIDS Research Institute, Pune and at TB Research Centre, Chennai.
Although this is India's third AIDS vaccine trial, it will be the first study on volunteers for a combination vaccine.
The key objective of the study on volunteers is that it is a principal booster approach with a single vaccine to activate the initial immune response which is being fared up by a second vaccination afterwards. To begin with, for the study, of the 32 healthy volunteers have been identified, 16 of them will at the National AIDS Research Institute, Pune and one at the TB Research Centre, Chennai who will receive two dosages of the ADAX shots followed by two dosages of TBC-M4.
ADVAX is a DNA vaccine, designed by Aaron Diamond Research Centre in New York and the TBC-M4 is an AIDS vaccine candidate made by an US firm in collaboration with Indian scientist Prof. Sekhar Chakrabarti who is a molecular biologist and visiting fellow at National Institutes of Health, USA working on viral diseases including HIV/AIDS and Rotavirus.
When the indigenous Modified Vaccinia Ankara (MVA) vaccine was tested in 2006-07, it was indicated that despite its high levels of safety parameters on humans it showed poor immune response to take it to the next phase of clinical trials. It was then that the scientists at the National AIDS Research Institute, Pune looked at a substitute option where it was decided to take MVA in combination with an imported DNA vaccine, stated sources.
In 2005, India initiated the first Phase I trial at NARI, Pune which saw an enrollment of 30 volunteers and was completed in December 2006.
A second phase-I was held to test the MVA vaccine was held at TRA, Chennai which saw 32 volunteers under go the study. Now the third study is expected top take off in a few weeks at NARI and TRA.
Since 1987, more that 100 global trials have been carried out with 40 kinds of AIDS vaccine on 15,000 volunteers. Some of these global studies are either complete or ongoing at Australia, China, Brazil, Botswana, Belgium. Canada, Finland, France, Germany, Haiti, Kenya, Malawi, Peru, Puerto Rico, South Africa, Switzerland, Thailand, United Kingdom, USA, Trinidad and Uganda.
India is a key partner in global research for AIDS vaccine. There are many leading medico scientists and research institutes which have collaborated with international institutes to develop a AIDS vaccine. In fact multiple vaccine candidates are being tested in India.
India has more than 5 million people living with HIV/AIDS, the world's second highest number of infections after South Africa, thus representing a high public health burden. Almost one-fourth of India's AIDS cases include children and those below 25 years. According to the National AIDS Control Organisation (NACO), 68 new cases of HIV are detected every hour. As the HIV epidemic is hitting across population segment, a specific efficacious and safe vaccine could help control the deadly virus, stated Prof. G Padmanabhan, scientist emeritus and former director, Indian Institute of Science.