New Delhi, Aug 12, 2010: The 102nd meeting of the Genetic Engineering Appraisal Committee (GEAC) held on  July 30, 2010 at the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad, India, decided to defer its decision on granting permission to conduct phase III clinical trials controlled study of the safety and immununogencity of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) by Sanofi Pasteur India.

This decision has come despite the recommendation of Indian Council for Medical Research (ICMR) for phase III clinical trials. During the deliberations, members expressed concern that JE-CV, a chimeric Flavivrus vaccine was derived from 17D strain of yellow fever vaccine and attenuated strain of SA-14-14-2 of the JE virus. As Flaviviruses are viable, non-homologous recombination between different Flavivirus species is a further possibility. Therefore, environmental risk of dissemination of Flavivirus (live vaccine virus) from the blood of immunized subjects through mosquitoes is an area of concern that needs to be addressed.

After detailed deliberations, the Committee opined, though the JE-CV live virus vaccines offers considerable promise in terms of efficacy and cost, Sanofi Pasteur may be advised to submit the  information on Seroconversion rate of JE-CV vaccine in comparison with the available brain mouse vaccine.

Besides the  information on adverse reactions during complete phase-II clinical trial and safety data, Sanofi might have to also submit information on whether the phase-II trials have been conducted without involving measles vaccine as directed by the GEAC in its letter dated Jan 28. 2008. Also information on the number of patients and age group to be tested in phase-III clinical trials also needs to be submitted to GEAC.

The objective of the clinical trial study is to asses JE-CV in phase III trials in pediatric populations in India. Subjects will be immunized with either a single dose administration of JE-CV at day 0 or with 3 doses of MBDV at day 0, day 7 and day 28, in accordance with the recommended regime of immunization for both vaccines.