Executive Summary:
The Ministry of Health and Family Welfare addresses concerns regarding dengue fever in India, including the ongoing Phase III clinical trial for India's first dengue vaccine, "DengiAll," led by the Indian Council of Medical Research (ICMR). The trial, involving over 10,000 participants across 20 sites, aims to evaluate the vaccine's efficacy against all four dengue virus serotypes. Government initiatives include monitoring outbreaks, providing support to states, and developing treatment guidelines due to the absence of specific antiviral treatments or licensed vaccines.
Key Points / Main Content:
Dengue Vaccine Trial:
* ICMR is conducting a Phase III clinical trial for the "DengiAll" dengue tetravalent vaccine.
* The trial is a multi-center, randomized, double-blind, placebo-controlled study.
* Over 70% enrolment is complete of over 10,000 participants across 20 sites in India.
* Karnataka has two trial sites (JSS Medical College and Hospital, Mysore; Bangalore Medical College Research Institute, Bengaluru) and Telangana has one (All India Institute of Medical Sciences, Bibinagar).
* The approximate budget per site for the trial is 1.3 to 1.5 crore Rupees.
Dengue Situation in India:
* In 2024, 573,563 laboratory-confirmed dengue cases were reported through the Integrated Health Information Platform (IHIP).
* All four dengue virus serotypes (DENV1, DENV2, DENV3, DENV4) circulate and co-circulate in India.
* Multiple serotypes can be present in the same region and infect the same individual simultaneously.
Government Measures:
* The Ministry of Health and Family Welfare, Director General of Health Services, and National Center for Vector Borne Disease Control (NCVBDC) monitor dengue outbreaks.
* Under the National Health Mission, budgetary support is provided to States/UTs for dengue control activities.
* Activities include epidemic preparedness, monitoring, case management, vector control, domestic breeding checkers, ASHA involvement, insecticide, fogging machines, training, intersectoral convergence, and awareness activities.
* Sentinel Surveillance Hospitals with laboratory facilities and Apex Referral laboratories have been identified for surveillance and free diagnosis.
* National guidelines on dengue case treatment management have been developed and shared with States/UTs.
* Advisories are issued to States/UTs for prevention and control, including case management.
Treatment and Prevention:
* There is no specific antiviral treatment or licensed vaccine for dengue; treatment is supportive.
Impact Analysis:
States and Union Territories:
* Impact: Need to implement national guidelines for dengue case management, utilize budgetary support for control activities, and adhere to advisories for prevention and control.
* Action Required: Prepare hospitals for case management, conduct vector control activities, raise awareness, and ensure surveillance.
Healthcare Professionals:
* Impact: Must follow national guidelines for dengue case treatment management, provide supportive care to patients, and remain updated on advisories for prevention and control.
* Action Required: Implement the guidelines in hospitals and clinics and stay informed about the latest advisories.
ICMR and Trial Sites:
* Impact: Responsible for conducting the Phase III clinical trial of the "DengiAll" vaccine and adhering to the trial protocol.
* Action Required: Continue the clinical trial, monitor participant safety and vaccine efficacy, and report results.
National Center for Vector Borne Disease Control (NCVBDC):
* Impact: Responsible for monitoring dengue outbreaks, providing technical guidance to States/UTs, and assessing the disease situation.
* Action Required: Continue monitoring outbreaks, provide guidance to States/UTs, and assess the effectiveness of control measures.
Key Entities Referenced
Dengue: A mosquito-borne viral disease that is a major public health concern in India.
Indian Council of Medical Research (ICMR): An apex body in India for the formulation, coordination and promotion of biomedical research, leading the third phase clinical trials for India's first dengue vaccine.
Dengue Tetravalent Vaccine, Live Attenuated Recombinant, Lyophilized DengiAll: The specific name of the dengue vaccine undergoing Phase III clinical trials in India.
National Centre for Disease Control (NCDC): An institute under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, responsible for disease surveillance and control.
Integrated Health Information Platform (IHIP): A platform used for reporting laboratory-confirmed dengue cases in India.
Telangana: A state in India where one of the clinical trial sites for the dengue vaccine is located, specifically at All India Institute of Medical Sciences Bibinagar.
Karnataka: A state in India where two of the clinical trial sites for the dengue vaccine are located, specifically at JSS Medical college and hospital, Mysore and Bangalore Medical College Research Institute, Bengaluru.
National Health Mission: A centrally sponsored scheme of the Government of India, providing budgetary support to States and Union Territories for Dengue control activities.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH RESEARCH
LOK SABHA
UNSTARREDQUESTION NO. 2165
TOBE ANSWERED ON01STAUGUST, 2025
TRIALOFDENGUE VACCINE
2165. DR. M PABDUSSAMAD SAMADANI:
SMT.D K ARUNA:
SHRIEATALARAJENDER:
Willthe Minister of HEALTHANDFAMILYWELFAREbe pleasedtostate:
(a) whether enrolment of participants in third phase clinical trials led by Indian Council of Medical
Research (ICMR) for India's first dengue vaccineisnearlycompleteand if so, the detailsthereof;
(b) whether dengue is a major public health concern in the country which ranks among the top 30
countries with the highest incidence of the disease and if so, the details thereof along with the corrective
steps beingtakenbythe Government inthisregard;
(c) whether there is currently no antiviral treatment or licensed vaccine for dengue in the country and if
so, detailsthereof;
(d) whether the trial islikely tobe rolledacross 20centresinthe country;
(e) if so, the results yieldedtill date alongwith the funds sanctioned,spent for Telangana andKarnataka;
(f) whether all four serotypes of the dengue virus are known to circulate or co-circulate inmany regions
across the country; and
(g) if so, the details thereof along with the measures undertaken by the Government to ensure that we
have aneffective vaccinethatachievesgoodefficacy for allfour serotypes of the said virus?
ANSWER
THE MINISTER OFSTATE INTHE MINISTRYOFHEALTH ANDFAMILYWELFARE
(SHRIPRATAPRAOJADHAV)
(a),(d) and(e): Indian Council of Medical Research (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”. 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. 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
1.3to1.5crore Rupeespersite for the trial.(b) (c)(f) and(g): As per the information provided by National Centre for Disease Control (NCDC) , a
total of 5,73,563 Laboratory confirmed (L form) Dengue cases were reported through Integrated Health
InformationPlatform (IHIP)inthe year2024.
According toICMR, allfour serotypes of the dengue virus(DENV-1,DENV-2, DENV-3,andDENV
-4) are known to circulate and co-circulate in India. Multiple serotypes can be present in the same
geographicalregion andcaneveninfect the same individual at the same time. Hence,participantshave been
enrolled in the ICMR vaccine trial from the different zones where these four serotypes circulate in order to
test the efficacy of the vaccineagainst all four serotypes.
The Ministry of HealthandFamily Welfare,Director General of HealthServicesandNational Center
for VectorBorne Disease Control (NCVBDC) regularlymonitor the situation of Dengue outbreaksacross the
country for assessing the disease situation, preparedness, technical guidance and to sensitize 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. 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. As per Indian Council of Medical
Research (ICMR), there is no specific antiviral treatment or licensed vaccines for dengue and the treatment
is supportive in nature. Government of India has developed National guidelines on Dengue case
treatment/management, in consultation with experts and shared with all States/UTs for implementation. The
guidelines emphasize on 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.
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