India’s dengue vaccine Phase-3 trial enrolment to be completed by Oct: ICMR

New Delhi, July 13 — India’s first indigenous one-shot dengue vaccine, DengiAll, developed by Panacea Biotec, is nearing a major milestone with over 8,000 of the targeted 10,500 participants enrolled in its Phase-III clinical trial, according to ICMR scientists.

The ongoing trial, launched in August 2023, is expected to complete enrolment by October 2025 across 20 centres nationwide, including Delhi, Pune, Chennai, Bhubaneswar, and Kolkata. The trial is being co-led by ICMR-National Institute of Virology (NIV), National Institute of Epidemiology (NIE), Chennai, and the National Institute of Translational Virology and AIDS Research, Pune.

A Step Toward India’s First Dengue Vaccine

There is currently no approved antiviral treatment or licensed dengue vaccine in India. DengiAll, a tetravalent vaccine, is designed to protect against all four dengue virus serotypes (DENV 1–4), which commonly co-circulate in India.

“Phase-1/2 results have shown no safety concerns. The ongoing Phase-III will now assess efficacy and long-term immunity over a two-year follow-up,” said Dr Manoj Murhekar, Director of NIE.

The double-blind, randomised, placebo-controlled trial is being conducted with support from the Indian Council of Medical Research (ICMR) and Panacea Biotec. The first volunteer was vaccinated at PGIMS Rohtak last year.

Vaccine Based on NIH Strain Shows Global Promise

The vaccine strain (TV003/TV005), initially developed by the U.S. National Institutes of Health (NIH), has shown encouraging results in Brazilian clinical trials. Of three Indian firms licensed to develop it, Panacea Biotec is furthest along, with a process patent for its formulation.

Developing an effective vaccine is challenging due to low cross-protection between dengue serotypes. Re-infections are common and more dangerous.

Urgency Amid Rising Dengue Cases

Dengue remains a major public health threat in India, among the top 30 countries globally for incidence. As per government data, 2.3 lakh cases and 297 deaths were reported in 2024. Although 75–80% of infections are asymptomatic, they still contribute to transmission via Aedes mosquitoes.

Children face higher risks of hospitalisation and mortality, while adults can develop severe forms like dengue hemorrhagic fever or dengue shock syndrome.