First Dengue Vaccine Phase 3 Clinical Trial Kicks off at KIMS
The third phase of the clinical trial for India’s first indigenous dengue vaccine, ‘DengiAll,’ began today at the Kalinga Institute of Medical Sciences (KIMS) here. This trial aims to evaluate the efficacy of the indigenous tetravalent dengue vaccine developed by Panacea Biotec, in collaboration with the Indian Council of Medical Research (ICMR).
KIMS is the only hospital in Odisha selected to conduct the Phase 3 trial, which involves 18 other sites across 18 states in India. 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.
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. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work.
Phase 1 and 2 clinical trials were completed in 2018-19, yielding promising results. “We have to recruit more than 500 participants in Bhubaneswar who would have volunteered for the third phase of the trial,” said a doctor involved in the process.
The trial commenced at KIMS attended by the Dean and Principal of KIMS, Dr. A P Mohanty; HoD of Community Medicine, Dr. Sonali Kar; and HoD Dept of Medicine, Dr. Lalatendu Mohanty. The Founder of KIIT and KISS, Dr. Achyuta Samanta, expressed confidence in the success of this third phase.
Dr. Sonali Kar, HOD Community Medicine, is the Principal Investigator for the study along with Dr. L. Mohanty, the HoD of the Deptt. of Internal Medicine, Prof. Dr. Dipti Pattnaik; HoD of the Deptt. of Microbiology, and Prof. Dr. Saurav Patra the Director of the Central Laboratory, KIMS, will oversee the operations, supported by an investigation team led by Prof. Dr. PC Samantaray.
The Site initiation visit (SIV) started on August 29, where the ICMR team from various institutes of ICMR, Sponsor from Panacea Bio-tech and JSS as CRO for the study visited KIMS to guide the trial team on operating procedures of the trial.
The global incidence of dengue has been steadily increasing over the past two decades. According to WHO, more than 129 countries have reported dengue viral disease by the end of 2023. 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.
The dengue virus has four serotypes, 1-4, which provide low cross-protection against each other. Therefore, an individual infected with one serotype is not immune to the others and can experience repeated infections.