New Delhi: India’s first indigenous dengue vaccine, DengiAll, has made significant progress in its Phase III clinical trial, with more than 70 per cent of participants enrolled so far, Union Minister of State for Health, Prataprao Jadhav, informed the Lok Sabha on Friday.
In a written reply to the Lok Sabha, Jadhav shared details on the Phase III clinical trial of the indigenous one-shot dengue vaccine, DengiAll. “The trial involves over 10,000 participants, out of which more than 70 per cent enrolment has been completed,” Jadhav said. The trial is likely to be completed by October. “The trial has been implemented in 20 sites across India. The approximate budget is Rs 1.3 to 1.5 crore per site for the trial,” he added.
DengiAll is a tetravalent, single-dose vaccine that targets all four dengue virus serotypes — DENV-1, DENV-2, DENV-3, and DENV-4. It is being developed by Panacea Biotec under a licensing agreement with the National Institutes of Health (NIH), the premier biomedical research agency of the United States. The vaccine has shown promising safety and immunogenicity in earlier trials, with no significant adverse events reported.
“According to the Indian Council of Medical Research (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,” Jadhav said. 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,” he added.
As per data from the National Centre for Disease Control (NCDC), India reported 5,73,563 laboratory-confirmed dengue cases in 2024. Despite the high burden of disease, there is currently no specific antiviral treatment or licensed vaccine for dengue in India.
To tackle this, the government has developed national guidelines for the treatment and management of dengue, which focus on improving hospital preparedness and clinical care. The development of DengiAll is seen as a potentially game-changing step in the fight against dengue, offering hope for long-term control of the mosquito-borne viral infection.