iGATE Clinical Research International announced today the successful completion of the phase I clinical trial of a new meningococcal A conjugate vaccine for 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.
Vaccine development partners include the Centre for Biologics Evaluation and Research (CBER), a centre of the US FDA for conjugation technology, and Serum Institute of India Limited (SIIL) for vaccine manufacturing. iGATE CRI was awarded a 5-year contract by MVP for clinical trial services spanning phase I to phase III testing that will include 7 clinical trials. The new meningococcal A vaccine is manufactured by Serum Institute of India Limited (SIIL).
Dr F Marc LaForce, director, Meningitis Vaccine Project said, "To avoid another devastating epidemic, conjugate meningococcal vaccines must be developed urgently and it was important for us to find a partner who could expedite the clinical trials. We look forward to working with them in our phase II and III trials."
Dr Vasudeo Ginde, president and managing director, iGATE CRI, added "We are proud of our association with MVP and SIIL in fighting meningococcal epidemics. Our commitment to ensuring the highest quality standards has ensured the safe completion of Phase I trials. We are prepared to replicate the same commitment in the Phase II and III trials to enable MVP and Serum Institute of India Limited to continue the development of this important vaccine."
A press release said, iGATE CRI commenced monitoring phase I trials in September 2004 in India and expects to initiate work on phase II trials in 2006. The phase I trial of the new vaccine was conducted in 72 subjects across three sites in India, B.Y.L Nair Hospital and King Edward Memorial Hospital in Mumbai, and Nizam's Institute of Medical Sciences in Hyderabad. The scope of services provided by iGATE Clinical Research for all trials includes clinical data management, bio-statistical analysis, pharmacovigilance, quality assurance & central laboratory services.
iGATE CRI also provided project management & monitoring for the phase I study. iGATE CRI also provided consultative services to Meningococcal Serology Laboratory at Centre for Disease Control and Prevention (CDC), Atlanta, and the Health Protection Agency (HPA), Manchester, UK, to ensure assay standardization across the vaccine development programme.
MVP's goal is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa. Meningitis is one of the most feared diseases in Africa. At least 10 per cent of infected individuals die during the acute episode and some 10-20 per cent of survivors develop permanent sequelae such as epilepsy, hearing loss, or mental retardation.