One-shot Dengue vaccine 'DengiAll' completes 70% enrolment of participants in Phase III trial: Centre
New Delhi: Seventy per cent of participant enrolment has been completed for the Phase III clinical trial of indigenous one-shot dengue vaccine, DengiAll, Minister of State for Health Prataprao Jadhav informed the Lok Sabha on Friday
The Indian Council of Medical Research (ICMR) has undertaken a large-scale trial titled phase III, which is designed as a multicentre, randomised, double-blind, placebo-controlled study to evaluate the vaccine’s efficacy, safety, and immunogenicity, Jadhav said.
"The trial involves over 10,000 participants, out of which more than 70 per cent enrolment has been completed. The trial has been implemented in 20 sites across India," he said.
The sites are JSS Medical College and Hospital, Mysuru (Karnataka), Bangalore Medical College and Research Institute, and All India Institute of Medical Sciences, Bibinagar (Telangana), PTI reported.
The approximate budget for the trial is Rs 1.3 to 1.5 crore per site, Jadhav said.
According to ICMR, there is no specific antiviral treatment or licensed vaccines for dengue and the treatment is supportive in nature, Jadhav said.
A total of 5,73,563 laboratory confirmed dengue cases were reported through the Integrated Health Information Platform (IHIP) in 2024, according to information shared by the National Centre for Disease Control (NCDC).
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 different zones where these four serotypes circulate in order to test the efficacy of the vaccine against all four serotypes, Jadhav said.
The minister also said that the Union Health Ministry, Director General of Health Services, and 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 the National Health Mission, adequate budgetary support is provided to states and Union territories for dengue control activities such as epidemic preparedness, monitoring, case management, vector control (provision of domestic breeding checkers, ASHA involvement, insecticide, fogging machines), training, intersectoral convergence, awareness activities, etc.
For surveillance and free of cost diagnosis of dengue, Sentinel Surveillance Hospitals with laboratory facility and Apex Referral laboratories with advance diagnostic facilities have been identified across the country, Jadhav said.
The government of India has developed national guidelines on dengue treatment/management, in consultation with experts, which have been shared with all the states and UTs for implementation.
The guidelines emphasise the preparedness of hospitals for case treatment/management.
In addition, advisories have been issued from time to time to states/UTs for prevention and control of dengue, including case management, the minister said.
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