India launches first-ever phase-three trial for indigenous dengue vaccine

New Delhi: In a significant step towards combating dengue fever, the Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated the first-ever phase three clinical trial for an indigenous dengue vaccine in India. The Union Health Ministry announced on Wednesday that the trial for the tetravalent vaccine, named DengiAll, commenced with the vaccination of the first participant at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak.

This large-scale trial will span 19 sites across 18 states and Union Territories, involving over 10,335 healthy adult participants. The study aims to evaluate the safety and efficacy of DengiAll, which targets all four serotypes of the dengue virus known to circulate in India.

Union Health minister J P Nadda hailed the initiative as a “critical advancement” in India’s fight against dengue. He emphasised that this endeavour not only demonstrates India’s commitment to public health but also reinforces the country’s vision of “Atmanirbhar Bharat” (self-reliant India) in the healthcare sector.

The development of DengiAll is particularly significant as India currently lacks any licensed vaccine or antiviral treatment for dengue. The disease poses a major public health challenge, with India ranking among the top 30 countries with the highest incidence of dengue globally.

Panacea Biotec, one of three Indian companies to receive the original vaccine strain developed by the US National Institutes of Health, has made substantial progress in developing a full-fledged vaccine formulation.

The company successfully completed phase one and two clinical trials in 2018-19, paving the way for this crucial phase three trial.

The trial, primarily funded by ICMR with partial support from Panacea Biotec, will follow participants for two years to assess long-term safety and efficacy.

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, the statement said.

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, the statement said.