Pancea Biotec previously reported positive data from the Phase I and II trials of DengiAll. Image credit: Shutterstock / Lightspring.

Panacea Biotec and the Indian Council of Medical Research (ICMR) are initiating a Phase III trial of a dengue fever vaccine.

This landmark trial (CTRI/2024/03/064910) will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll.

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The virus has become a major public health concern in India, ranking it among the top 30 countries with the highest incidence of the disease.

Union Minister of Health and Family Welfare Shri Nadda said: “The initiation of this Phase III clinical trial for India’s first indigenous dengue vaccine marks a critical advancement in our fight against dengue. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India’s capabilities in vaccine research and development.

“Through this collaboration between ICMR and Panacea Biotec, we are not only taking a step towards ensuring the health and well-being of our people but also reinforcing our vision of Atmanirbhar Bharat in the healthcare sector.”

DengiAll is based on the tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH) which has shown promise in previous studies.

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Panacea Biotec is one of three Indian companies to receive the strain and has already conducted a Phase I/II trial (CTRI/2017/02/007923) of the formulation.

In collaboration with ICMR, Panacea Biotec will conduct the Phase III clinical trial across 19 sites in 18 States and Union Territories of India, involving more than 10,335 healthy adult participants.

The trial, primarily funded by ICMR, with partial support from Panacea Biotec, will follow up with participants for two years.

Development of dengue vaccines began in the 1920s but was slowed by the need to create immunity against all four dengue serotypes. As of last year, there were only two commercially available vaccines, sold under the brand names Sanofi’s Dengvaxia and Takeda’s Qdenga, but these are not approved globally.

There are no antiviral treatments or licensed vaccines against dengue in India. In India, all four serotypes of the dengue virus are known to circulate or co-circulate in many regions.

GlobalData reports that the Asia-Pacific dominates the dengue fever market with more than 50% of the clinical trials conducted as of July 2023.

GlobalData is the parent company of the Clinical Trials Arena.