CDSCO panel gives nod for continuation of phase-II clinical trial of SII’s dengue vaccine

A tetravalent live-attenuated dengue vaccine was manufactured in India after receipt of vaccine strains from NIAID, NIH, USA.

ByPTI

Published Jun 07, 2024 | 11:41 AMUpdatedJun 07, 2024 | 11:41 AM

Vaccine

An expert committee under the Central Drug Regulatory Authority has recommended the continuation of a phase-II clinical trial of the Serum Institute of India (SII)’s vaccine against dengue after noting the promising results of the phase-I interim clinical trial.

The Serum Institute conducted the phase-I, double-blind, randomised, placebo-controlled trial on 60 healthy individuals aged 18 to 45 years in Australia to assess the safety and immunogenicity of the tetravalent live-attenuated dengue vaccine.

A tetravalent live-attenuated dengue vaccine was manufactured in India after receipt of vaccine strains from NIAID, NIH, USA.

“A single dose of dengue vaccine was safe and well tolerated in adults. The vaccine was highly immunogenic with trivalent or tetravalent seroconversion and seropositivity in most of the participants,” stated the study results published in Vaccine, a journal by Elsevier, last year in August.

In light of recommendation of the subject expert committee dated 18 July 2023, the SII presented the phase-I interim clinical trial report of Dengue Tetravalent Vaccine (Live, Attenuated) which was discussed by the panel on 31 May.

“After detailed deliberation, the committee noted the results of Phase I interim clinical trial and recommended for continuation of Phase II clinical trial as per approved protocol,” the SEC recommendations stated.

Also Read: Kerala, Karnataka top the list of dengue cases in the country

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