Pune, Chennai trials for AIDS vaccine await nod

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Pune, Chennai trials for Aids vaccine await nod

Siddhartha D Kashyap Tuesday, December 09, 2008 01:45 IST

PUNE: 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 is being planned simultaneously both at the

National Aids Research Institute (Nari) in Pune and the Chennai-based

Tuberculosis Research Centre (TRC), " said 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 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 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).

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