The Indian Council of Medical Research (ICMR) and Panacea Biotec has announced the initiation of the first-ever Phase 3 clinical trial for a dengue vaccine in India. Developed by Panacea Biotec, the trial is to evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, informed Ministry of Health & Family Welfare.
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak became the first participant of the trial as he received the vaccination on August 14, 2024.
J.P. Nadda, Union Minister of Health & Family Welfare, commenting on the turning point for India stated, “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.”
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The Ministry stated that the research for an effective dengue vaccine is complex, “due to the need to achieve good efficacy for all four serotypes.” At present, India is still combating on successfully bringing out an antiviral treatment or licensed vaccine against dengue. The four serotypes of Dengue virus are known to circulate or co-circulate in many regions in India.
The tetravalent dengue vaccine strain (TV003/TV005) is originally developed by the National Institutes of Health (NIH), USA and has shown promising results in preclinical and clinical trials worldwide. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development.
Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 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, is set to follow up with participants for two years.
