New Delhi: The Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated the Phase 3 clinical trial for DengiAll, an indigenous tetravalent dengue vaccine developed in India. This trial marks a significant milestone in the nation's efforts to combat dengue, a disease for which no antiviral treatment or licensed vaccine currently exists in the country.
The Phase 3 trial will be conducted at 19 sites across 18 States and Union Territories, involving more than 10,335 healthy adult participants. The participants will be followed for two years, with the first vaccination administered at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.
The challenge in developing an effective dengue vaccine lies in achieving good efficacy against all four serotypes of the virus, which are known to circulate or co-circulate in many regions. The successful development of this vaccine could have a profound impact on public health in India.
Speaking about the indigenous dengue vaccine, Union Minister of Health & Family Welfare, JP Nadda, said, “The initiation of this Phase 3 clinical trial for India's first indigenous dengue vaccine marks a critical advancement in our fight against dengue. 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.”
The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the NIH, has shown promising results worldwide, and the Indian formulation's earlier trials in 2018-19 further strengthen the hope for a successful outcome in this critical Phase 3 trial.