India on course to developing first indigenous dengue vaccine

The Phase 3 clinical trial for India’s first dengue vaccine has enrolled over 7,248 participants since its launch in August 2024, marking a major milestone in the development of an indigenous dengue vaccine.

- Vicky Pathare

The trial, led by the Indian Council of Medical Research (ICMR) in collaboration with Panacea Biotec, is testing DengiAll, a tetravalent vaccine designed to protect against all four known dengue virus serotypes.

The vaccine strain (TV003/TV005), originally developed by the US National Institutes of Health (NIH), has shown promising results in global studies. The NIH later sub-licensed the technology to several firms globally including Indian companies like Panacea Biotec and Indian Immunologicals.

Among the Indian licensees, Panacea Biotec is the most advanced, having completed Phase 1 and 2 trials in 2018-19. The company has since developed a full vaccine formulation and holds a process patent.

The ongoing multi-centre, double-blind, randomized, placebo-controlled Phase 3 trial began on August 14, 2024, and aims to recruit 10,355 healthy volunteers aged 18-60 years across 19 clinical sites in India.

The trial has received all regulatory approvals from the Drug Controller General of India (DCGI). Enrolment is expected to conclude by October 2025, with each participant to be monitored for two years. Data will be submitted to the Central Drugs Standard Control Organisation (CDSCO) for review.