CDSCO Panel Approves Continuation Of Phase-II Trials For SII's Dengue Vaccine
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 safety and immunogenicity of the tetravalent live attenuated dengue vaccine.
An expert committee under the Central Drug Regulatory Authority has recommended continuation of phase-II clinical trial of the Serum Institute of India'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 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 July 18, 2023, the SII presented phase-I interim clinical trial report of Dengue Tetravalent Vaccine (Live, Attenuated) which was discussed by the panel on May 31.
"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.
