New Delhi, August 14, 2024: In a landmark development for India’s healthcare sector, the Indian Council of Medical Research (ICMR) and Panacea Biotec have initiated the first-ever Phase 3 clinical trial for a dengue vaccine in the country. This pivotal trial aims to assess the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. The first participant was vaccinated today at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
Currently, India lacks an antiviral treatment or a licensed vaccine against dengue, making the development of an effective vaccine a complex yet urgent need. The challenge lies in achieving robust efficacy across all four serotypes of the dengue virus, which are known to circulate or co-circulate in various regions across India.
The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has demonstrated promising results in global preclinical and clinical trials. Panacea Biotec, one of three Indian companies to receive this strain, is leading the charge in vaccine development. The company has extensively worked on these strains to create a comprehensive vaccine formulation and holds a process patent for this innovative work. The Phase 1 and 2 clinical trials of the Indian formulation were successfully completed in 2018-19, showing encouraging results.
In partnership with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial at 19 sites across 18 States and Union Territories, involving over 10,335 healthy adult participants. The trial, which will track participants for two years, is primarily funded by ICMR, with additional support from Panacea Biotec. This initiative represents a monumental step towards developing an indigenous vaccine to address one of India’s most pressing public health challenges and is a testament to the nation’s commitment to achieving self-reliance (Atmanirbhar Bharat) in the healthcare sector.
Background on Dengue in India
Dengue continues to be a major public health concern in India, with the country ranking among the top 30 nations with the highest incidence of the disease. According to the World Health Organization (WHO), the global incidence of dengue has surged over the past two decades, with more than 129 countries reporting cases by the end of 2023. In India, approximately 75-80% of dengue infections are asymptomatic, yet these individuals can still transmit the virus through Aedes mosquitoes. Among the 20-25% of cases where symptoms are clinically apparent, children are at a significantly higher risk of hospitalization and mortality. In adults, the disease can progress into severe conditions such as dengue hemorrhagic fever and dengue shock syndrome. The dengue virus has four serotypes (1-4), and due to low cross-protection among them, individuals can experience multiple infections over their lifetime.
The initiation of this Phase 3 clinical trial marks a critical step forward in India’s efforts to combat dengue and underscores the country’s growing capabilities in vaccine research and development.
