iGATE Clinical Research Contributes to Successful Completion of Phase I Testing of Meningitis A Conjugate Vaccine



iGATE Clinical Research International today announced 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 Center for Biologics Evaluation and Research (CBER - a centre of the United States Food and Drug Administration [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).

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's8217;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 Center for Disease Control and Prevention (CDC), Atlanta, and the Health Protection Agency (HPA), Manchester, UK, to ensure assay standardization across the vaccine development program.

MVP's8217;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 percent of infected individuals die during the acute episode and some 10-20 percent of survivors develop permanent sequelae such as epilepsy, hearing loss, or mental retardation. In the so called 'smeningitis belt's that stretches from Ethiopia to Senegal, meningococcal disease has killed more than 100,000 people between 1988 and 1997, with more than 704,000 cases reported to the World Health Organization. Existing polysaccharide vaccines are only partially effective.

Speaking on the need for the vaccine and the partnership with iGATE CRI, Dr. F. Marc LaForce, Director, Meningitis Vaccine Project said, 's8220;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. The successful and timely completion of the Phase I trials by iGATE is an important milestone that validates our selection of iGATE CRI after an extensive evaluation process. We look forward to working with them in our Phase II and III trials.'s8221;

Dr. Suresh Jadhav, Executive Director (Q.A) at Serum Institute of India Ltd said, 's8220;We are very happy to be associated with all our partners in this project to develop the Meningococcal A Conjugate vaccine at an affordable cost to eliminate meningitis epidemics in the Sub-Saharan African belt.'s8221;

Dr. Vasudeo Ginde, President and Managing Director, iGATE CRI, added 's8220;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.'s8221;

About The Meningitis Vaccine Project
The Meningitis Vaccine Project (http://www.meningvax.org) is a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH). It was established in May 2001 through a grant from the Bill & Melinda Gates Foundation. The mission of MVP is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa through the development, testing, introduction, and widespread use of conjugate meningococcal vaccines. Vaccine development partners include the Center for Biologics Evaluation and Research (CBER -- a centre of the United States Food and Drug Administration [US FDA) for conjugation technology, and Serum Institute of India Limited (SIIL) for vaccine manufacturing.

About iGATE Clinical Research International
iGATE Clinical Research International (iGATE CRI) is a leading contract research organization with offices in Pittsburg, USA & Mumbai, India, offering end-to-end services for conducting Phase I-IV clinical trials in India. In its ninth year of operations, the company is a part of NASDAQ listed iGATE Corp.

iGATE Clinical Research is amongst the first clinical trials management companies to establish operations in India, and has a substantial track record in conducting ICH-GCP compliant work in clinical research for multinational biopharmaceutical clients including 5 of the top 20 global pharmaceutical companies.

The comprehensive array of their services include Clinical Operations and monitoring, Project management, Central Lab services, Data management, Bio-statistical services, Quality assurance and Regulatory support.

About Serum Institute of India
Created in 1967, Serum Institute of India Limited (SIIL - http://www.seruminstitute.com) has emerged as a top supplier of quality vaccines and the world's8217;s largest manufacturer of measles vaccine and DTP vaccines. Currently, SIIL products are being exported to 150 countries. At least one of two children born throughout the world is administered a measles or DTP vaccine manufactured by SIIL.

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iGATE Clinical Research Contributes to Successful Completion of Phase I Testing of Meningitis A Conjugate Vaccine