India joins the global search to stop AIDS spread

EPP News Bureau - Mumbai

India began its first-ever human clinical trial of an investigational vaccine candidate designed to prevent HIV/AIDS by a partnership between the Government of India through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organisation (NACO)and the not-for-profit International AIDS Vaccine Initiative (IAVI).

The Phase I trial that began on February 7 is being conducted at ICMR’s National AIDS Research Institute (NARI) in Pune, outside of Mumbai, and is testing a vaccine candidate named tgAAC09 (recombinant adeno-associated viral vector, rAAV).

Targeted Genetics Corp. (NASDAQ:TGEN), a Seattle-based bio-technology company, and Columbus Children’s Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with IAVI.

The vaccine candidate tgAAC09 is modelled after subtype C of HIV, the subtype that accounts for the most infections worldwide and is prevalent in many developing countries, including India and South Africa. tgAAC09 is designed so that it cannot cause HIV infection or AIDS; it consists of an artificially made copy of a portion of HIV’s genetic material.

The trial will take roughly 15 months to complete and will enroll 30 volunteers, men and women, who are in good health and not infected with HIV. The trial in India is part of a multi-country Phase I trial of tgAAC09 that is also underway in Europe; researchers in Germany and Belgium are testing the vaccine candidate in partnership with IAVI.

Regulatory approval to test tgAAC09 in India was granted by the Drugs Controller General, the Health Ministry Steering Committee, the Genetic Engineering Approval Committee, the NARI Scientific Committee, the NARI Ethics Committee and the National Ethics Committee. Announcing the trial, the Union Minister of Health and Family Welfare, Dr Anbumani Ramadoss, said, “Developing a vaccine to prevent AIDS is one of the most difficult scientific challenges of our time. It is also one of the most urgent health needs. Perseverance is the way forward, and India has a long-term commitment.”

IAVI Board Member and Minister of State, Science and Technology Mr. Kapil Sibal said, “Vaccine research is so critical that the Health Ministry and the Science and Technology Ministry have joined hands to provide the effort the support it needs.”

Dr N K Ganguly, Director General of ICMR, heralded the trial as part of the Indian government’s commitment to combat the AIDS epidemic, saying, “Our country is an emerging global leader in biomedical research. With this first trial, Indian scientists are making an important contribution that will bring the world a step closer to an AIDS vaccine.”