CHENNAI: The successful completion of phase-1 of clinical trials of the ASIDS vaccine developed here has indicated that it had acceptable levels of safety and was well tolerated, say the Indian Council of Medical Research (ICMR), National AIDS Control Organisation (NACO) and International AIDS Vaccine Initiative (IAVI). The trial relied on an Modified Vaccinia Ankara (MVA) based AIDS vaccine candidate (TBC-M4).
The response levels of volunteers suggested that it holds promise, the three organisations said in a joint statement. The trial used two doses of the MVA. 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 … but hope to learn more through further testing,” said S.K. Bhattacharya, additional director general of ICMR.
“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,” he added. The phase I clinical trial was started in January 2006 at the Tuberculosis Research Centre (TRC), an ICMR institute in Chennai, and was completed in February 2008.
This trial was conducted under the aegis of a MoU between the central government through ICMR and NACO and IAVI. YRG CARE, based in Chennai, collaborated with TRC to mobilise the community around the phase I trial.