Phase-3 Dengue Vaccine Trial Nears Completion by October

Scientists at the Indian Council of Medical Research (ICMR) expect that the phase-III clinical trial of DengiAll, developed as the first ever indigenous dengue vaccine of India, will reach the enrollment of about 10,500 people by October 2025.

Panacea Bio has developed a tetravalent, single-dose vaccine and is currently carrying out a multi-centre, double-blind, placebo-controlled, randomised trial in August 2023. To date, more than 8,000 volunteers in 20 centres in such cities as Pune, Chennai, Delhi, Kolkata, and Bhubaneswar have undergone a placebo or a vaccine.

ICMR-National Institute of Translational Virology and AIDS Research (Pune), National Institute of Epidemiology (Chennai), and National Institute of Virology (Pune) are the co-leaders of the trial. Those accepted will allow the observation of their efficacy, safety of the vaccine, and long-term immunogenicity during two years.

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Dr Manoj Murhekar, the Director of NIE Chennai, reported that there had been no safety issues noted in Phase I/II. This is because the difficulty in vaccination is how to overcome the protective balance in all four serotypes (1-4) of the virus, which tends to co-circulate in Indian areas.

Dengue fever is a significant health hazard, and India is one of the 30 countries where the problem of the disease ranks high. A symptomatic infection occurs with great frequency (7580%), but a symptomatic infection could cause hospital admission or even death, such as dengue hemorrhagic fever. In 2024, India reported more than 2.3 lakh cases and 297 deaths.