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India is on the verge of a major public health milestone as enrolment for the third phase of clinical trials for the country’s first indigenous dengue vaccine, DengiAll, approaches completion. The trial, a collaboration between the Indian Council of Medical Research (ICMR) and Panacea Biotec, is being conducted across 19 sites in 18 states and union territories, with a target of recruiting over 10,000 healthy adult participants.
DengiAll, a tetravalent vaccine developed under a licensing agreement with the US National Institutes of Health (NIH), is designed to protect against all four dengue virus serotypes. The vaccine has already shown promising safety and efficacy results in earlier Phase I and II trials, with a balanced immune response and no significant safety concerns reported so far.
The Phase 3 trial, which began in August 2024, has already surpassed the halfway mark, with over 7,000 participants enrolled as of July 2025. Participants, aged between 18 and 60, receive either the vaccine or a placebo, and will be followed for two years to monitor long-term outcomes. The Drug Controller General of India has approved the study, and enrolment is expected to conclude by October 2025.
Union Health Minister J P Nadda described the trial as a “critical advancement in our fight against dengue,” highlighting the importance of indigenous vaccine development for national health security. Currently, there is no licensed dengue vaccine or antiviral treatment available in India, and the disease remains a significant public health challenge due to the complexity of achieving efficacy against all four virus serotypes.
“The initiation of this phase three 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,” said Health Minister Nadda.
The DengiAll vaccine contains weakened forms of all four dengue virus subtypes, mirroring the composition of the NIH-developed vaccine except for inactive ingredients. Early-stage clinical studies in the US and India have both indicated strong safety and immune responses.
Disclaimer:
This article is based on information available as of July 2025 regarding ongoing clinical trials. The DengiAll dengue vaccine is still under evaluation and has not yet received regulatory approval for public use. The safety and efficacy of the vaccine will be determined upon completion of the Phase 3 trial and subsequent review by health authorities. Readers are advised to consult official health sources for updates and should not interpret this information as medical advice or an endorsement of the vaccine.
