New Delhi, February 7
India today began its first-ever human clinical trial of an investigational vaccine candidate, tgAAC09, designed to prevent the global epidemic of HIV/AIDS.
Announcing the administration of the vaccine to the first volunteer at the ICMR’s National AIDS Research Institute(NARI), Pune, Health Minister Anbumani Ramdoss said here that the primary purpose of the Phase I clinical trial of the vaccine, being developed with the help of an international partnership, was to evaluate its safety.
The Phase I stage of human testing of the vaccine, in which 30 volunteers in good health and not infected with HIV are participating, will take about 15 months to complete.
Volunteers, include men and women in the age group of 18 to 45 years, who have given consent after series of counseling sessions and meetings. Their health has been checked to see that they do not suffer from any major infections. After the Phase I trial, the tgAAC09 will be tested in a series of longer trails to evaluate its safety, immunogenicity, efficacy and eventually determine if the vaccine can offer clinical benefit against HIV/AIDS.
Partners in the programme includes the Indian Government - the Indian Council of Medical Research (ICMR) and the National AIDS Control Organisation (NACO)-besides the not-for-profit International AIDS Vaccine Initiative(IAVI) and the biotechnology company Targeted Genetics Corp of the USA.
The entire clinical trial of the vaccine, specifically designed against the HIV type C, which is the most prevalent form of the virus in India, will take at least eight to 10 years. The single-shot vaccine has been genetically engineered and is a synthetic copy of a portion of HIV’s genetic material inserted into adeno-associated virus.
The vaccine is unlike a traditional vaccine, with weakened strains of avirus. Scientists in the country are also working on three other vaccine candidates and the clinical trial of one of them, the MVA vaccine, is likely to begin in Chennai in five to six months time. ICMR Director-General N.K. Ganguly said the vaccine, which is unrelated to HIV, does not cause the disease in humans. It has shown encouraging results in monkeys, protecting some of them from developing AIDS after they became infected with an AIDS-like virus. Because what works in animals only provides a guide for what might work in humans, hence the human clinical trials.
Minister of Science and Technology Kapil Sibal, who is also an IAVI board member, was also present. The phase I trial of the vaccine is also undergoing in Germany and Belgium. The results from the phase I trial on 50 individuals in the two European nations have shown it to be safe, Dr Ganguly added.
President and CEO of IAVI Seth Berkley, who joined through teleconferencing, said eight governments, the European Union, the World bank and various foundations, corporations and individuals were financing the IAVI’s efforts.
The vaccine development cost is about $50 million and clinical trials will require hundreds of millions of dollars if it is found effective after the three-phase clinical trial. Regulatory approval to test the vaccine 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.
