India’s first Indigenous dengue vaccine ‘DengiAll’ enters Phase 3 clinical trials

New Delhi: The Indian Council of Medical Research (ICMR) and Panacea Biotec have launched a Phase 3 clinical trial for India’s first indigenous dengue vaccine, DengiAll.

This trial will test the vaccine’s effectiveness, marking a significant milestone in the nation’s battle against the mosquito-borne disease. The first participant was vaccinated today at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.

This trial, conducted in collaboration with ICMR, will be carried out across 19 sites in 18 States and Union Territories, involving over 10,335 healthy adult participants. The trial, primarily funded by ICMR and supported by Panacea Biotec, will track participants over two years to evaluate the vaccine’s safety and effectiveness.

Union Health Minister J.P. Nadda highlighted, “The initiation of this Phase 3 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.”

Dengue poses a serious health challenge in India, with no current antiviral treatment or approved vaccine available. The complexity of creating a dengue vaccine lies in ensuring strong protection against all four virus serotypes, which often circulate simultaneously in many parts of the country.

The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH) in the United States, has demonstrated promising results in both preclinical and clinical trials globally. Panacea Biotec, one of the Indian companies to receive the strain, has advanced the development of this vaccine and holds a process patent for its formulation. The Phase 1 and 2 clinical trials conducted in India in 2018-19 yielded encouraging results, paving the way for this large-scale Phase 3 trial.