India's landmark Dengue vaccine trial enrolment to wrap up by October: ICMR

Written by Ruchika Sharma Published On 2025-07-14T11:54:03+05:30 | Updated On 14 July 2025 11:54 AM IST

Indias landmark Dengue Vaccine trial enrolment to wrap up by October: ICMR

New Delhi: An ongoing Phase III clinical trial of DengiAll, a one-shot dengue vaccine developed by Panacea Biotec, is progressing in India. According to scientists from the Indian Council of Medical Research (ICMR), the enrolment of around 10,500 participants is expected to be completed by October 2025 across 20 centres nationwide, marking a key milestone in the evaluation of this potential breakthrough vaccine.

So far, 8,000 participants across trial sites in cities including Pune, Chennai, Delhi, Kolkata, and Bhubaneswar among others have received either DengiAll or a placebo as part of the study sponsored by the Indian Council of Medical Research (ICMR) and Panacea Biotec.

The trial is co-led by ICMR-National Institute of Translational Virology and AIDS research in Pune, National Institute of Epidemiology (NIE), Chennai and National Institute of Virology, Pune, PTI reported.

Currently, there is no antiviral treatment or licensed vaccine against dengue in India.

The results of the Phase-1/2 trial has shown no safety concerns for the one-shot vaccine, NIE Director Dr Manoj Murhekar said.

"The participants enrolled in the Phase- III trial will be followed up for two-years. This trial will evaluate the efficacy of this tetravalent dengue vaccine," Dr Murhekar said.

The multi-centre, double-blind, randomised, placebo-controlled phase-III trial was launched in August last year to evaluate the jab's efficacy, safety and, long-term immunogenicity.

The first participant in this trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak last year.

The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. The dengue virus has four serotypes, 1-4, with low cross-protection against each other, meaning individuals can experience repeated infections, Dr Murhekar said.

In India, all four serotypes of dengue virus are known to circulate or co-circulate in many regions.

The Union Health Ministry in a statement earlier had said that the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in clinical trials in Brazil. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work.

Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease.

The global incidence of dengue has been steadily increasing over the past two decades, with more than 129 countries reporting dengue viral disease by the end of 2023, according to the World Health Organisation (WHO).

In India, approximately 75-80 per cent of infections are asymptomatic, yet these individuals can still transmit the infection through the bite of Aedes mosquitoes.

Among the 20-25 per cent of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalisation and mortality. In adults, the disease can escalate into severe conditions like dengue hemorrhagic fever and dengue shock syndrome.

According to the government data, around 12,043 dengue cases were reported till March this year. In 2024, 2.3 lakh cases and 297 deaths had been recorded.

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751