India Nears Completion of Phase III Dengue Vaccine Trials

New Delhi/Hyderabad: The Ministry of Health and Family Welfare has confirmed significant progress in the Phase III trial of India's first dengue vaccine, “DengiAll.” This clinical study, conducted by the Indian Council of Medical Research (ICMR), aims to evaluate the efficacy of a live attenuated tetravalent vaccine against all four known serotypes of the dengue virus.

This update was provided in response to a question raised by Eatala Rajender, a Member of Parliament, during a Lok Sabha session on Friday. The multi-centre trial has enrolled over 10,000 participants, with more than 70% of the enrollment completed. The study is being conducted at 20 designated research centres across India, including key sites such as JSS Medical College and Hospital in Mysore (Karnataka), Bangalore Medical College & Research Institute in Bengaluru (Karnataka), and AIIMS Bibinagar in Hyderabad (Telangana). Each site has been allocated a budget of approximately Rs 1.3 to Rs 1.5 crore.

Dengue remains a major public health challenge in India. Data from the Integrated Health Information Platform (IHIP) indicates that there were 573,563 laboratory-confirmed dengue cases reported in 2024, ranking the country among the top 30 worldwide for disease prevalence.Currently, there is no licensed antiviral treatment or vaccine available for dengue in India. The treatment protocol is supportive, following national clinical management guidelines developed by the Union Health Ministry. These guidelines have been shared with all states and Union Territories to enhance preparedness and response capabilities during outbreaks.

Given the circulation of all four dengue virus serotypes (DENV-1 to DENV-4) across different regions of India—sometimes even within the same individual—the ICMR has strategically selected trial zones that reflect this viral diversity. This method aims to assess the vaccine's broad-spectrum efficacy.

In parallel, the government is implementing efforts under the National Health Mission (NHM), which include vector control measures, fogging operations, public awareness campaigns, and improved surveillance infrastructure. Sentinel Surveillance Hospitals and Apex Laboratories have been established to facilitate free diagnosis and reporting.