ICMR and Panacea Biotec begin Phase 3 clinical trial of India’s 1st indigenous dengue vaccine DengiAll

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 Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak.

Union Health Minister JP Nadda hailed the initiative, stating, “The initiation of this Phase 3 clinical trial for India's first indigenous dengue vaccine marks a critical advancement in our fight against dengue.”

Emphasizing the importance of the collaboration between ICMR and Panacea Biotec for the development of the dengue vaccine, the Union Health Minister noted that "Through this partnership, 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."

Currently, the country has no antiviral treatment or licensed vaccine for dengue, making the development of an effective vaccine a complex and urgent need. The challenge lies in achieving high efficacy across all four serotypes of the dengue virus, which are known to circulate or co-circulate in many regions of the country.

The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials globally. Panacea Biotec, one of three Indian companies to receive this strain, has made the most progress in developing a complete vaccine formulation.

The company holds a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results.

The Phase 3 clinical trial, conducted in collaboration with ICMR, will take place across 19 sites in 18 States and Union Territories, involving over 10,335 healthy adult participants.

It is important to note that Dengue is a major public health concern in India, ranking among the top 30 countries with the highest incidence of the disease. According to WHO report approximately 75-80% of infections in India are asymptomatic, yet these individuals can transmit the infection through the bite of Aedes mosquitoes. Among the 20-25% of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalization and mortality.