Business Daily from THE HINDU group of publications
Thursday, Aug 03, 2006
iGate CRI sees larger role in meningitis vaccine trial
P. T. Jyothi Datta
The vaccine is an initiative of the Meningitis Vaccine Project, a partnership between the World Health Organisation and an American NGO
It is expected to be priced at less than 50 cents
Mumbai , Aug. 2
Contract research organisation iGate Clinical Research International (iGate CRI) sees its role getting "larger and more complex" in the clinical trial of the meningococcal A conjugate vaccine, as it enters the second phase of human trials in Africa.
Phase I trial
The vaccine has recently completed its phase I trial it was tested on 72 healthy volunteers across three hospitals in Mumbai and Hyderabad. iGate CRI commenced monitoring Phase I trials in September 2004 in India and expects to initiate work on Phase II trials in 2006.
Dr Vasudeo Ginde, President and Managing Director of iGate CRI, told Business Line that its role will get bigger and more complex as the trial rolls into its second phase in Africa, where the vaccine will be targeted and tested on a larger sample size of people with the illness.
"We are in charge of pharmaco-vigilence (among other things), so the complexity increases because the base mortality rate there is high," he said. Besides, the sheer distance and the new population bring with it challenges, he indicated. The trial on the meningitis A conjugate vaccine is a first time of sorts, since phase I is sparingly given regulatory clearance in India, Dr Ginde observed.
The trials were done at Mumbai's KEM and Nair Hospitals, besides Hyderabad's Nizam's Institute.
On why Phase II trials were not being done in India, he said, "Africa has the most tangible and known population with the disease, so it was fitting in terms of the numbers."
The vaccine is an initiative of the Meningitis Vaccine Project (MVP), a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH), an American NGO based in Seattle.
It was established in May 2001 through a grant from the Bill & Melinda Gates Foundation.
Pune's Serum Institute is one of the co-sponsors, besides the US-based Centre for Biologics Evaluation and Research. Serum Institute will manufacture the vaccine on completion.
The idea was to get an effective vaccine that would cost less than 50 cents, he said. And there is a sense of urgency to the project, as it targets having an effective vaccine in place before the next epidemic that is expected to hit Africa in 2007-08, he said.
iGATE CRI was awarded a five-year contract by MVP for clinical trial services spanning Phase I to Phase III, testing that will include seven clinical trials.
The CRO manages the clinical data, bio-statistical analysis, quality assurance and central laboratory services. It also supplies lab-kits for analysis to Atlanta's Centre for Disease Control and Prevention (CDC) and Manchester's Health Protection Agency (HPA) to ensure assay standardisation across the vaccine development program.
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