Pune, Chennai trials for Aids vaccine await nod

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.

Siddhartha D Kashyap, for DNA

"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 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 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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