ICMR Has Undertaken Phase III Placebo Controlled Study To Evaluate Efficacy Of Single Dose Of Dengue Vaccine: Centre

New Delhi: The Union Health Ministry on Friday said that the Indian Council of Medical Research (ICMR) has undertaken a phase III, multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy, immunogenicity and safety of a single dose of dengue tetravalent vaccine "DengiAll".

"The ICMR has informed that it has undertaken a clinical trial titled 'A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of Single dose of Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized) – 'DengiAll'," said Minister of State for Health Pratarao Jadhav in the Lok Sabha.

He said that the trial involves over 10,000 participants, out of which more than 70 per cent enrollment has been completed.

"The trial has been implemented in 20 sites across India. There are two sites in Karnataka and one site in Telangana. These sites are JSS Medical College and Hospital, Mysore (Karnataka), Bangalore Medical College & Research Institute, Bengaluru (Karnataka) and All India Institute of Medical Sciences, Bibinagar (Telangana). The approximate budget is Rs 1.3 to 1.5 crore per site for the trial," said Jadhav while replying to an unstarred question raised by Dr MP Abdussamad Samadani, D K Aruna and Eatala Rajender.

As per the information provided by the National Centre for Disease Control (NCDC), a total of 5,73,563 laboratory confirmed (L form) dengue cases were reported through Integrated Health Information Platform (IHIP) in 2024, Jadhav stated.

According to ICMR, all four serotypes of the dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4) are known to circulate and co-circulate in India.

"Multiple serotypes can be present in the same geographical region and can even infect the same individual at the same time. Hence, participants have been enrolled in the ICMR vaccine trial from the different zones where these four serotypes circulate in order to test the efficacy of the vaccine against all four serotypes," the minister said.

He said that the Ministry of Health and Family Welfare, the Director General of Health Services and the National Centre for Vector Borne Disease Control (NCVBDC) regularly monitor the situation of dengue outbreaks across the country for assessing the disease situation, preparedness, technical guidance, and to sensitise and forewarn the states.

"Under National Health Mission, adequate budgetary support is provided to States and Union Territories for Dengue control activities like epidemic preparedness, monitoring, case management, vector control (provision of domestic breeding checkers, ASHA involvement, insecticide, fogging machines), training, intersectoral convergence, awareness activities, etc," Jadhav said.

For surveillance and free-of-cost diagnosis of dengue, sentinel surveillance hospitals with laboratory facilities and apex referral laboratories with advanced diagnostic facilities have been identified across the country.

"As per the ICMR, there is no specific antiviral treatment or licensed vaccines for dengue, and the treatment is supportive in nature. The Government of India has developed National guidelines on Dengue case treatment and management, in consultation with experts and shared with all States and UTs for implementation. The guidelines emphasise on the preparedness of hospitals for case treatment and management. In addition, advisories have been issued from time to time to States and UTs for prevention and control of dengue, including case management,” Jadhav informed.