Completion of Phase-3 Enrolment for India's First Dengue Vaccine Expected Soon

In a significant advancement in public health, India's first indigenous dengue vaccine, developed by Panacea Biotec, is set to complete its Phase-3 clinical trial enrolment by October 2025. The trial, which is sponsored by the Indian Council of Medical Research (ICMR), aims to evaluate the vaccine's efficacy, safety, and long-term immunogenicity. Launched in August 2024, the trial has thus far enrolled approximately 8,000 participants across 20 centers in cities such as Pune, Chennai, Kolkata, Delhi, and Bhubaneswar, with a target of reaching 10,500 participants by the completion date.

The primary investigator for the trial, Dr. Manoj Murhekar, Director of the National Institute of Epidemiology (NIE), highlighted that the vaccine, named DengiAll, is a tetravalent formulation designed to protect against all four serotypes of the dengue virus, which presents significant challenges due to low cross-protection among the serotypes. "The participants enrolled in the Phase-III trial will be followed up for two years to assess the vaccine's efficacy," Dr. Murhekar stated, emphasizing the importance of this research in combating dengue, which is a major public health concern in India.

Dengue fever, transmitted by Aedes mosquitoes, has seen a troubling rise in incidence rates worldwide, with the World Health Organization (WHO) reporting over 129 countries affected by the disease as of late 2023. In India, the situation is especially critical, with approximately 12,043 dengue cases reported by March 2025 and a staggering 2.3 lakh cases and 297 deaths recorded in 2024 alone. According to government data, between 75% to 80% of infections remain asymptomatic, yet these individuals can still transmit the virus, complicating efforts to control outbreaks.

The trial's design is multi-centre, double-blind, and randomized, ensuring rigorous testing standards in line with international clinical trial protocols. The vaccine strain, TV003/TV005, originally developed by the National Institutes of Health (NIH) in the United States, has shown promising results in earlier trials conducted in Brazil. Panacea Biotec is currently one of three Indian companies licensed to develop this strain, and it is at the forefront of advancing this vaccine formulation, holding a process patent for its work.

Experts believe that the successful development and eventual rollout of DengiAll could transform dengue prevention strategies in India, where the four serotypes of the virus circulate widely, making immunization critical. Dr. Sarah Johnson, an epidemiologist at the Harvard T.H. Chan School of Public Health, noted that an effective dengue vaccine could significantly reduce hospitalizations and mortality associated with severe dengue cases, particularly among children who are at a higher risk.

The implications of this vaccine are profound, not only for public health in India but also for global health initiatives aimed at reducing the burden of vector-borne diseases. As the enrolment phase nears completion, the medical community and public health officials await the trial results, which could pave the way for the first licensed dengue vaccine in India, addressing a long-standing need in the face of rising dengue cases and outbreaks.

The urgency for effective dengue prevention strategies is underscored by the ongoing global trends in disease incidence, making the successful outcome of this trial a critical milestone in the fight against dengue fever. As India continues to battle the challenges posed by this disease, the DengiAll vaccine represents a beacon of hope for health authorities and communities alike.