Inventor:  Dr Chetan Chitnis and Dr. Virander S. Chauhan, ICGEB, New-Delhi
Project Team Leader:  Nathalie Imbault, EVI
Product Leader:  Dr. Shams Yazdani, ICGEB, New-Delhi
Manufacturer:  Bharat Biotech International Limited, Hyderabad
Clinical Trial Principal Investigator:  Dr. Sandhya Ravi (Lotus Labs Pvt. Ltd., Bangalore, India)
Clinical Trial Management:  DiagnoSearch Laboratoies Services, Mumbai, India

Product Development
Production of three (3) consistency batches by Bharat Biotech International Limited in Hyderabad (sub-contracted by International Centre for Genetic Engineering and Biotechnology, New Delhi) was completed in December 2007, and the toxicology report was compiled in March 2009 by Intox Pvt. Ltd., Pune, India.

Clinical Development Sponsored by ICGEB and EVI
A Phase I, Randomised, Controlled, Dose-Escalating, Single-Blind Clinical Trial to Evaluate the Safety and Immunogenicity of JAIVAC-1 Vaccine (rPfMSP-119and rPfF2) formulated with Montanide ISA720 in Healthy Indian Males between 18 to 45 Years of Age

The Investigational New Drug (IND) application has been made to the Drug Controller General of India (DCGI). The IND Committee met on 18 December and the project team is awaiting recommendations. The clinical trial, due to start Q1 2010, will be conducted at Lotus Labs Pvt. Ltd., Bangalore, India. The management of the clinical trial has been delegated to DiagnoSearch Laboratoies Services, a Contract Research Organisation (CRO), Mumbai, India.

Life of the Project
The JAIVAC-1 project team is very pleased to welcome on board Dr Kavita Singh and Dr Shantanu Mehta from the Indian Malaria Vaccine Program, New Dehli, India