India Launches Landmark Phase 3 Dengue Vaccine Trial

The ICMR and Panacea Biotec have commenced the first phase three clinical trial for an indigenous dengue vaccine, DengiAll, in India. The trial will involve over 10,335 healthy participants across 19 sites. This initiative aims to address the growing dengue public health crisis, with no existing licensed vaccine in the country.

The ICMR and Panacea Biotec have commenced the first-ever phase three clinical trial for a dengue vaccine in India, the Union Health Ministry announced on Wednesday.

The indigenous tetravalent dengue vaccine, named DengiAll, was developed by Panacea Biotec, and the first participant was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak.

The clinical trial will span 19 sites across 18 states and union territories, involving over 10,335 healthy adult volunteers.

Union Health Minister J P Nadda stated, "The initiation of this phase three clinical trial marks a significant step forward in our battle against dengue. It underscores India's commitment to protecting its citizens and showcases the nation's vaccine research and development capabilities."

This collaboration between ICMR and Panacea Biotec is seen as a move towards Atmanirbhar Bharat in the healthcare sector. There is currently no licensed vaccine or antiviral treatment for dengue in India.

The development of an effective vaccine is complicated by the need to address all four serotypes of the dengue virus, which co-circulate in many regions of India.

The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH) in the USA, has shown promising results globally. Panacea Biotec, one of the three Indian companies to receive this strain, has advanced the most in its development.

Following successful phase one and two trials completed in 2018-19, the phase three trial aims to observe participants for two years.

Dengue remains a major public health issue in India, part of the top 30 countries with the highest incidence. According to WHO, more than 129 countries reported cases by the end of 2023. In India, a large portion of infections are asymptomatic but still transmissible, posing a higher risk for children and leading to severe conditions in adults.

(With inputs from agencies.)