The Indian Council of Medical Research (ICMR) and Panacea Biotec on Wednesday announced the commencement of the Phase 3 clinical trial of India's first indigenous dengue vaccine, DengiAll, at the Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak.
Health Minister JP Nadda lauded the initiative and said, “The initiation of this Phase 3 clinical trial for India’s first indigenous dengue vaccine marks a crucial step forward in our fight against dengue.”
Highlighting the importance of the collaboration between ICMR and Panacea Biotec for the development of dengue vaccine, the Health Minister noted, “Through this collaboration, we are not only taking a step towards ensuring the health and well-being of our people but also strengthening our vision of Atmanirbhar Bharat in the healthcare sector.”
Currently, the country has no antiviral treatment or approved vaccine for dengue, making the development of an effective vaccine a complex and urgent need. The challenge lies in achieving high efficacy for all four serotypes of dengue virus, which are known to circulate or co-circulate in many regions of the country.
The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide. Panacea Biotec, one of the three Indian companies to receive this strain, has made the most progress in developing a complete vaccine formulation.
The company has a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19 and yielded promising results.
The Phase 3 clinical trial, being conducted in collaboration with ICMR, is being conducted at 19 sites in 18 states and union territories and will involve over 10,335 healthy adult participants.
It is important to note that Dengue is a major public health problem in India and is among the top 30 countries with the highest incidence of the disease. According to the WHO report, about 75-80% of infections in India are asymptomatic, but these individuals can transmit the infection through the bite of Aedes mosquitoes. Of the 20-25% of cases where symptoms are clinically apparent, children are at significantly higher risk of hospitalization and death.
