India trials investigational vaccine candidate designed to prevent HIV/AIDS

Feb 7 2005

India's has begun it's first-ever human clinical trial of an investigational vaccine candidate designed to prevent HIV/AIDS. The trial is being conducted by a partnership between the Government of India -- through the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO) -- and the not-for-profit International AIDS Vaccine Initiative (IAVI).

Announcing the trial, 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: "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."

Dr. S. Y. Quraishi, Director General of NACO, said: "The trial initiation is a great culmination of the tripartite partnership among ICMR, NACO and IAVI. We expect to test other vaccine candidates in the coming years under this partnership."

More than 20 years after HIV/AIDS was identified, new infections are occurring worldwide at the rate of 14,000 every day. Public health experts agree that it is essential to develop a safe and effective vaccine.

Researchers are pursuing multiple vaccine candidates simultaneously because it is not certain which of many possible designs may prove effective.

Dr. Seth Berkley, President and CEO of IAVI, highlighted the need for global partnership: "The partnership in India is an example of the kind of international collaboration that is critical to the quest for a vaccine. We must work together to mobilize the best science in the fight against the epidemic."

The Phase I trial that began today is being conducted at ICMR's National AIDS Research Institute (NARI) in Pune, outside of Mumbai, and is testing a vaccine candidate named tgAAC09. Targeted Genetics Corp., a Seattle-based biotechnology company, and Columbus Children's Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with IAVI.

The vaccine candidate tgAAC09 is modeled 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.

A Phase I vaccine trial is the first stage of human testing, and the primary purpose is to evaluate safety. 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. For the trial in Germany and Belgium, approval was obtained from authorities in the countries.

tgAAC09 utilizes a vaccine-making technology called recombinant adeno- associated viral vector (rAAV). This showed encouraging results in animals, protecting some of them from developing AIDS after they became infected with a HIV-like virus. Because what works in animals only provides a guide for what might work in humans, researchers now need to study tgAAC09 in clinical trials.