This is the first-ever government led vaccine trial after the BCG vaccine trial that was undertaken decades ago. After a detailed land scape analysis of the available vaccine candidates, two potential vaccines were shortlisted for a ICMR led Phase III trial of 12000 healthy house hold contacts of sputum smear positive TB patients.
Clinical Development Services Agency (CDSA), launched by Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India in 2009, has provided study start-up support to all sites and oversaw the recruitment and vaccination of the first participant at National Institute of Tuberculosis and Respiratory Diseases (NITRD) New Delhi on 15th July 2019.
The trial launch at NITRD, Delhi was attended by Dr. Balram Bhargava, Secretary, DHR & Director General, ICMR, Dr. Rohit Sarin – Director, NITRD, Dr. Manjula Singh- Scientist “E” EDC, ITRC-ICMR project team and CDSA team members - Dr. Monika Bahl, Ms. Shubhra Bansal, Mr. Tarun Puri and Ms. Jinisha Shukla.
Dr. Bhargava emphasised the need in India where the disease is endemic for clinical trials to show that the vaccine is safe and effective. Participants will be recruited from twelve sites in six states—Delhi, Karnataka, Maharashtra, Orissa, Tamil Nadu and Telangana.
CDSA is an extramural unit of Translational Health Science & Technology Institute (THSTI), Faridabad.
