Context
India has reached an important milestone by launching the first Phase III clinical trial of an indigenous tetravalent dengue vaccine, DengiAll.
About DengiAll:
- DengiAll has been developed by Panacea Biotec Limited under a licensing agreement with the National Institutes of Health (NIH) in the United States.
- The vaccine contains a weakened form of all four dengue virus subtypes, similar to the NIH-developed version but with different inactive ingredients. Earlier Phase I and II trials in India demonstrated that DengiAll produced a robust and balanced immune response against all four virus types. It was also found to be safe and well-tolerated.
The Phase III Clinical Trial
- India’s Phase III trial is being coordinated by the Indian Council of Medical Research (ICMR). The study plans to recruit 10,355 healthy adults aged 18 to 60 years across 20 sites in India.
- As of now, over 7,000 participants have been enrolled and randomised. Participants are assigned in a 2:1 ratio to receive either the vaccine or a placebo. The trial is approved by the Drug Controller General of India and aims to complete enrolment by October this year.
- Participants will be followed up for two years after vaccination to evaluate the vaccine’s efficacy, safety, and immunogenicity. Overall trial management is being handled by a dedicated national institute under ICMR.
About Dengue:
- Dengue fever is a major public health challenge in India and many tropical countries. The World Health Organization (WHO) has identified dengue among the top 10 global health threats. India contributes significantly to the global dengue burden, with data from the National Centre for Vector Borne Diseases Control showing around 2.3 lakh dengue cases and 297 deaths reported in 2024 alone.
- Dengue is caused by infection with any of the four dengue virus subtypes transmitted by Aedes mosquitoes. There is no specific antiviral treatment, and severe cases can result in bleeding, shock, and death. As a result, prevention through vaccination has long been a key priority.
How the Vaccine Helps
- Experts involved in the study have explained that this vaccine could significantly advance the prevention of dengue, which currently has no curative treatment.
- Vaccination is expected to protect against severe manifestations such as bleeding, sudden drops in blood pressure, and potentially life-threatening complications.
Conclusion
India’s Phase III trial of DengiAll represents a major step towards developing a safe, effective, and domestically produced dengue vaccine. If successful, the vaccine could reduce dengue-related illness and mortality across the country.
With enrolment already crossing the halfway mark, this effort highlights India’s growing capabilities in vaccine development and clinical research. It also shows how local innovation and collaboration with global institutions can help address pressing public health challenges.
