Phase III clinical trial for India's 1st dengue vaccine hits 70pc enrolment mark: Minister

New Delhi, Aug 1 (IANS) The phase III clinical trial for India’s 1st dengue vaccine has enroled 70 per cent participants, said Union Minister of State for Health, Prataprao Jadhav, in the Parliament 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.

The indigenous tetravalent dengue vaccine, DengiAll, is being developed by Panacea Biotec under a licensing agreement with the National Institutes of Health (NIH). The vaccine targets all four dengue virus subtypes and has shown promising results in earlier clinical trials.

As per data from the National Centre for Disease Control (NCDC), a total of 5,73,563 laboratory-confirmed (L form) dengue cases were reported in 2024.

“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.

DengiAll is being developed by Panacea Biotec under a licensing agreement with the National Institutes of Health (NIH), the primary US federal agency for biomedical research. Initial results show no safety concerns for the one-shot vaccine to fight the mosquito-borne viral disease.

Citing ICMR, Jadhav said there is no specific antiviral treatment or licensed vaccines for dengue.

The government has also developed National guidelines on Dengue case treatment/management, which emphasise the preparedness of hospitals for case treatment/management, the minister noted.

--IANS

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