The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of India's first-ever Phase 3 clinical trial for an indigenous dengue vaccine, marking a significant milestone in the country's fight against one of its most pressing public health challenges. The first participant in this landmark trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.
Critical Public Health Need
Dengue represents a major public health concern in India, which ranks among the top 30 countries with the highest incidence of the disease globally. According to the World Health Organization (WHO), more than 129 countries reported dengue viral disease by the end of 2023, with global incidence steadily increasing over the past two decades. In India specifically, approximately 75-80% of infections are asymptomatic, yet these individuals can still transmit the infection through Aedes mosquito bites.
Among the 20-25% of cases where symptoms are clinically apparent, children face significantly higher risks of hospitalization and mortality. In adults, the disease can escalate into severe conditions including dengue hemorrhagic fever and dengue shock syndrome. Currently, there is no antiviral treatment or licensed vaccine against dengue available in India.
Vaccine Development Challenges and Innovation
The development of an effective dengue vaccine presents unique complexities due to the need to achieve good efficacy against all four dengue virus serotypes. In India, all four serotypes are known to circulate or co-circulate in many regions, with low cross-protection between serotypes meaning individuals can experience repeated infections.
The tetravalent dengue vaccine DengiAll is based on strains (TV003/TV005) originally developed by the National Institutes of Health (NIH), USA, which have shown promising results in preclinical and clinical trials worldwide. Panacea Biotec, one of three Indian companies to receive these strains, has reached the most advanced stage of development and holds a process patent for their extensive formulation work.
Phase 3 Trial Design and Scope
The Phase 3 clinical trial will be conducted across 19 sites in 18 states and union territories of India, involving more than 10,335 healthy adult participants. The trial is primarily funded by ICMR with partial support from Panacea Biotec and is designed to follow participants for two years to evaluate vaccine efficacy and safety.
Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results that supported progression to the current Phase 3 evaluation.
Government Support and Strategic Vision
Union Minister of Health & Family Welfare, Shri J.P. Nadda, emphasized the significance of this development, 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. It reflects our commitment to protecting our citizens from this pervasive disease and underscores India's capabilities in vaccine research and development."
The minister further highlighted how this collaboration between ICMR and Panacea Biotec represents a step toward ensuring public health while reinforcing India's vision of Atmanirbhar Bharat (self-reliant India) in the healthcare sector.
Disease Burden and Impact
India accounts for an estimated 100-400 million dengue infections globally, with the disease typically reaching peak incidence during monsoon seasons. The dengue virus, primarily transmitted by Aedes aegypti mosquitoes active during daylight hours, can cause symptoms ranging from mild to severe, with potentially fatal outcomes, especially in individuals with compromised immunity.
This Phase 3 trial represents a significant step toward developing an indigenous vaccine solution for addressing dengue's substantial public health and economic burden in India, potentially offering protection against all four circulating dengue virus serotypes through a single vaccination approach.
