Bhubaneswar: The third phase of the clinical trial for India’s first indigenous dengue vaccine, ‘DengiAll,’ commenced at the Kalinga Institute of Medical Sciences (KIMS) here Sunday. The trial began in the presence of the Dean and Principal of KIMS AP Mohanty; HoD, Community Medicine Sonali Kar, and HoD, General Medicine, Lalatendu Mohanty. Kar along with Mohanty, Dipti Pattnaik of the Department of Microbiology, and Saurav Patra, the Director of the Central Laboratory will oversee the operations, supported by an investigation team led by PC Samantaray.
The site initiation visit (SIV) started August 29, when the Indian Council of Medical Research (ICMR) team from various institutes of ICMR, Sponsor from Panacea Biotech and JSS as CRO for the study visited KIMS to guide the trial team on operating procedures of the trial. The trial aims to evaluate the efficacy of the indigenous tetravalent dengue vaccine developed by Panacea Biotec, in collaboration with the ICMR, institute officials said. KIMS is the only hospital in Odisha selected to conduct the Phase III trial, which involves 18 other sites across 18 states in India. “We have to recruit more than 500 participants in Bhubaneswar who would have volunteer for the third phase of the trial,” said a doctor involved in the process.
Notably, India ranks among the top 30 countries with the highest incidence of dengue, with Odisha ranking sixth among the states. Telangana tops the chart, followed by Delhi and Rajasthan. “Currently, there is no antiviral treatment or licensed vaccine against dengue in India. Developing an effective vaccine is complex due to the need for good efficacy across all four serotypes of the dengue virus, all of which are known to circulate or co-circulate in many regions of India,” officials said. “The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide,” they said.
ARINDAM GANGULY, OP