India's first-ever human clinical trial of an investigational vaccine candidate designed to prevent HIV/AIDS, 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), has started today.
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 (recombinant adeno-associated viral vector, rAAV). 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 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.
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."
Dr. N K Ganguly, director general of ICMR, said, "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."
The trial will take roughly 15 months to complete and will enrol 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.
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.