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In a historic development, India has completed more than 50% enrollment in the phase III of its first indigenous dengue vaccine, DengiAll. As of now, the one-shot vaccine to fight the mosquito-borne viral disease has shown no signs of safety concerns, according to the researchers. The Indian Council of Medical Research (ICMR) and Panacea Biotec anticipate the completion of the trial by October of this year. Earlier, phase I and phase II clinical trials had shown great promise and had also gotten positive feedback from the National Institutes of Health (NIH), the primary US federal agency for biomedical research.
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Why is DengiAll Important?
The World Health Organization (WHO) lists dengue as one of the ten most urgent global health priorities, and India is home to a major chunk of that dengue-affected population. Data received from the National Centre for Vector Borne Diseases Control, suggests that there were approximately 12,043 cases of dengue reported until the March of 2024 in the country, while in the same year, India also saw 297 deaths due to the disease. Dengue is a mosquito-borne viral disease that has no treatment available and therefore, a vaccine for prevention would be a significant advantage to India's fight against dengue. Dr Sheela Godbole, director, ICMR-NITVAR and the national principal investigator of the trial, reported to the media that follow up on the trial can be expected to be complete by the end of 2027. “DengiAll has a weakened form of all four dengue virus subtypes and has the same virus composition as the vaccine developed by NIH, except for the inactive ingredients. The NIH also evaluated the vaccine in the US and the results were found to be promising in the early-stage clinical studies,” she said.
Also Read: Dengue Prevention Isn’t Just About Mosquitoes: Here Are Home And Diet Fixes That Matter Too
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A Large Scale Trial
The ICMR-National Institute of Translational Virology (NITVAR) and AIDS Research (earlier ICMR-NARI) has the overall responsibility for the coordination of the trial. The study, coordinated by the Indian Council of Medical Research (ICMR), aims to recruit 10,355 volunteers aged 18-60 years and will be following them up for two years post-vaccination. Participants will either receive the vaccine or a placebo. The trial has been sanctioned by the Drug Controller General of India (DCGI) and will finish recruitment by October. There are 20 trial sites in the following cities: Chennai, Pune (two sites), Mysuru, Hyderabad, Puducherry, Kochi, Jodhpur, Ranchi, Kolkata, Aligarh, Patna, Rohtak, Ludhiana, Bengaluru, New Delhi, Bhubaneswar, Rishikesh, Guwahati, and Faridabad. The research teams for the sites are from reputable medical institutes being three from ICMR.
Conclusion
Dengue has been a long standing thorn for India’s healthcare system. The disease particularly affects the middle and lower class populations and is known to be rampant in the monsoon season. The inception of India’s first indigenous dengue vaccine is potentially a huge breakthrough, however, it remains to be seen whether the trials live up to the promise or not.