Serum Institute of India (SII) has received the green light from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) to advance clinical trials for two critical vaccines. The approvals encompass a Phase II/III trial for a typhoid conjugate vaccine (bivalent) and a Phase III trial for a yellow fever vaccine, marking significant steps in combating these infectious diseases.
Typhoid Conjugate Vaccine (Bivalent) Trial
The SEC granted approval for SII to conduct a Phase II/III clinical trial of its typhoid conjugate vaccine (bivalent) after reviewing the Phase I clinical trial report. The study is designed as a Phase II/III, double-blind, randomized, active-controlled, multicentric trial. It aims to evaluate the safety, immunogenicity, and lot-to-lot consistency of the vaccine in healthy individuals aged 6 months to 65 years. The vaccine targets Salmonella enterica serovars Typhi and Paratyphi A.
The approval is contingent upon SII submitting a Phase II study report along with a Data and Safety Monitoring Board (DSMB) review for approval before initiating the Phase III study. Typhoid fever, caused by Salmonella typhi, can lead to severe complications and fatality if untreated. Typhoid conjugate vaccines (TCVs) are recommended by the WHO due to their improved performance, single-dose administration, and suitability for young children, providing protection for at least 4 years with a single dose and proven safety and efficacy in children older than 6 months.
Yellow Fever Vaccine Trial
SII also received a nod to proceed with a Phase III clinical trial for its yellow fever vaccine. This decision followed the submission of an interim analysis of the Phase II safety and immunogenicity study report, along with DSMB recommendations and a revised Phase III study protocol. Yellow fever, a viral disease transmitted by infected mosquitoes, poses epidemic risks and is preventable through vaccination. The yellow fever vaccine uses a live, weakened version of the virus to confer protection.
The SEC's decision was influenced by the interim results of the Phase II clinical trial. The committee has recommended the conduct of the Phase III clinical trial as per the presented revised protocol.
