A second Phase I AIDS vaccine clinical trial in India was successfully completed, the Indian Council of Medical Research, the National AIDS Control Organization and the International AIDS Vaccine Initiative announced.
The results of the trial of an MVA-based AIDS vaccine candidate (TBC-M4), which was conducted in Chennai, indicated that the vaccine candidate had acceptable levels of safety and was well tolerated.
The proportion of volunteers whose immune systems responded to the vaccine candidate suggests the candidate holds promise. The trial was done using two doses of the candidate vaccine. After three injections, 82 percent of the volunteers who received a low dose and 100 percent of those who received a high dose registered immune responses to the vaccine. The 100 percent response rate is greater than that seen with the majority of AIDS vaccine candidates tested in humans to date. However the strength and diversity of these immune responses were modest. It may be possible to boost the immune response, if this vaccine is used in combination with other candidate AIDS vaccines.
“We are pleased to see that the MVA-based candidate tested in Chennai was safe and showed promising initial immune responses. We do not know whether these observed responses will ultimately translate into an effective vaccine that will help protect individuals from HIV infection, but hope to learn more through further testing,” said Dr. S K Bhattacharya, Additional Director General of the Indian Council of Medical Research. “India is playing a significant role in global AIDS vaccine discovery efforts given our strong medical and scientific capabilities. There is a need for continued efforts for the creation of novel, reliable mechanisms for long-term research on AIDS vaccines and other new prevention technologies.”
The Phase I clinical trial was initiated in January 2006 at the Tuberculosis Research Center (TRC), an Indian Council of Medical Research (ICMR) institute in Chennai, and was completed in February 2008. This trial was conducted under the aegis of a Memorandum of Understanding (MoU) 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). YRG CARE, based in Chennai, collaborated with TRC to mobilize the community around the Phase I trial.
Dr. Narayanan, former Director of the Tuberculosis Research Center, added, “Consistent innovation in science despite setbacks has ensured the development of many effective prevention technologies. The successful conduct of the trial in Chennai re-affirms the need for continued vaccine development initiatives, where learnings from every effort will contribute to global advancement of the AIDS vaccine field.”
Source: International AIDS Vaccine Initiative, USA