SII's Dengue Vaccine: Green Light for Phase-II Trials After Promising Results

An expert committee under the Central Drug Regulatory Authority has recommended the continuation of phase-II clinical trials for Serum Institute of India's dengue vaccine, following promising results from the phase-I trial conducted on healthy individuals in Australia aged 18 to 45 years.

An expert committee under the Central Drug Regulatory Authority has urged the continuation of phase-II clinical trials for the Serum Institute of India's (SII) dengue vaccine, after the phase-I interim clinical trial yielded promising results.

Phase-I trials, which were double-blind, randomised, and placebo-controlled, took place in Australia, involving 60 healthy participants aged 18 to 45 years. The study aimed to assess the safety and immunogenicity of the tetravalent live attenuated dengue vaccine developed by SII.

The results showed that a single dose of the vaccine was safe, well-tolerated, and highly immunogenic, leading to seroconversion in most participants. Following these positive outcomes, an expert committee meeting on May 31 recommended the advancement to Phase II trials.

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