India Begins First Phase 3 Trial for Indigenous Dengue Vaccine

The Hindu, New Delhi, August 2024: India has launched its first-ever phase 3 clinical trial for a dengue vaccine, involving over 10,335 healthy adult participants across 19 sites in 18 States and Union Territories. Panacea Biotec, with support from the Indian Council of Medical Research (ICMR), developed the indigenous tetravalent dengue vaccine, DengiAll, which is based on a strain originally created by the U.S. National Institutes of Health and has already demonstrated promising results in global trials. Panacea Biotec, one of three Indian companies working with this strain, is leading the vaccine’s development with a process patent. Phase 1 and 2 trials in India, completed in 2018-19, yielded positive outcomes.

The first participant in this phase 3 trial was vaccinated at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak on Wednesday. Primarily funded by ICMR, this trial seeks to assess the vaccine’s efficacy, marking a crucial milestone in India’s efforts to combat dengue. Union Health Minister J.P. Nadda 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.” This vaccine is crucial as there is currently no licensed dengue vaccine or antiviral treatment available in India.