AIDS Vaccine Await nodPune, Chennai Trials for
Clinical trials for an AIDS vaccine are likely to begin in Pune and Chennai.
The International AIDS Vaccine Initiative (Iavi), along with the National AIDS Control Organisation (Naco) and the Indian Council of Medical Research (ICMR), has submitted a protocol for the trials to the Drugs Controller General of India (DCGI) for its approval. The proposed phase I of the clinical trials will use a MVA-based prime boost regime.
“The proposed trials are being planned simultaneously both at the National Aids Research Institute (Nari) in Pune and the Chennai–based Tuberculosis Research Centre (TRC),” said Lisa Beyer, vice–president (communications) of Iavi, who was in Pune. Both Nari and TRC have already carried out phase I clinical trials using two Aids vaccine candidates.
The idea to conduct another phase I clinical trials in India gained momentum after the completion of the Chennai trials earlier this year. The vaccine candidate, administered on healthy volunteers in Chennai was TBC-M4, based on a vector built from recombinant Modified Vaccinia Ankara (MVA). It was designed by a biotech firm in the US in collaboration with Dr Sekhar Chakrabarty from the National Institute of Cholera and Enteric Diseases (NICED).
It targets HIV-1 subtype C, the most predominant HIV subtype in India. Soon after the completion of the clinical trials in Chennai, Iavi had said the results of the vaccine trial of TBC–M4 suggest that further research is warranted.
Iavi had said the new trial will include a DNA–based vaccine candidate called ADVAX to prime the immune system. “It is hoped that the prime–boost regimen will help to strengthen the modest immune responses observed in the Phase I trial of the MVA–based candidate alone.” Nari officials said the trial protocol will be finalised soon.
Deputy director of Nari Dr. Sanjay Mehendale said the new vaccine candidate will have additional genes to boost the immune system. Volunteers will be administered more than one dosage. Mehendale was the principal investigator of the first–ever Aids vaccine clinical trials in Pune, where 30 healthy volunteers were administered the injectible vaccine candidate tgAAC09 (recombinant adeno-associated virus vector).
Friday, Mar 24th
Last update:05:44:44 AM IST