- ICMR and Panacea Biotec launch India's first Phase 3 clinical trial for indigenous dengue vaccine DengiAll, with the first participant vaccinated at PGIMS Rohtak.
- The trial will involve over 10,335 participants across 19 sites in 18 states and Union Territories, testing the effectiveness of a tetravalent dengue vaccine strain.
- Meanwhile, Takeda's dengue vaccine Qdenga, pre-approved by WHO, has shown to reduce dengue cases by over 50% and elicit immune responses in over 90% of recipients.
The Indian Council of Medical Research (ICMR) and Panacea Biotec have begun India's first Phase 3 clinical trial for a dengue vaccine. This important trial will test the effectiveness of Panacea Biotec's indigenous tetravalent dengue vaccine, DengiAll.
The first participant was vaccinated on Wednesday at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.
“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,” said Shri J.P. Nadda, Union Minister of Health & Family Welfare.
India currently has no antiviral treatment or licensed vaccine for dengue, a situation complicated by the need to target all four circulating serotypes of the virus.
The tetravalent dengue vaccine strain (TV003/TV005), developed by the National Institutes of Health (NIH) in the USA, has shown promise in global trials. Panacea Biotec, one of three Indian companies to receive the strain, is leading the development efforts. The company has developed a vaccine formulation and completed successful Phase 1 and 2 clinical trials in 2018-19.
In partnership with ICMR, Panacea Biotec will conduct Phase 3 trials across 19 sites in 18 states and Union Territories, involving over 10,335 healthy adult participants. Funded mainly by ICMR with additional support from Panacea Biotec, the trial will monitor participants for two years.
In other news, the dengue vaccine Qdenga, which received pre-approval from the World Health Organization (WHO) in May, has been found to reduce dengue cases by over 50% and has a strong safety record.
Developed by Takeda Pharmaceutical Industries, this live-attenuated vaccine contains weakened forms of the four types of the DENV virus.
A comprehensive review of 19 studies, involving over 20,000 people, found that more than 90% of adults and children developed an immune response against all four types of the virus after receiving the two-dose vaccine. The studies included data from Asia and South America, regions where dengue is prevalent.
Edited by Harshajit Sarmah
