Phase-3 clinical trial of India’s first dengue vaccine begins at KIMS-Bhubaneswar
BHUBANESWAR, SEPT 3: The phase-3 clinical trial for India’s first Indigenous dengue vaccine, ‘DengiAll,’ commenced at the Kalinga Institute of Medical Sciences (KIMS) on Tuesday.
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 third phase trial, which involves 18 other sites across 18 states in the country.
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.
The tetravalent dengue vaccine (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 extensively worked on these strains to develop a full-fledged vaccine formulation and has been granted 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 volunteer for the third phase trial,” said a vaccine investigator involved in the process.
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, 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.
Dr Sonali Kar, head of the Community Medicine department and principal investigator for the study said the site was selected after teams from various institutes of ICMR Panacea Biotech visited KIMS. They guided the trial team on the operating procedures of the trial.
Dr L Mohanty, HoD of the Internal Medicine department, Prof Dipti Pattnaik, HoD of the Microbiology department and Prof Saurav Patra, director of the Central Laboratory at KIMS will oversee the operations, supported by an investigation team led by Prof PC Samantaray.
Founder of KIIT and KISS Achyuta Samanta expressed confidence in the success of this third phase. The Dean and Principal of KIMS Dr AP Mohanty was also present.
-The New Indian Express
