The above study findings have been published in the ScienceDirect, Vaccine journal 126998 to assess a double-blind, randomized phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in a diverse participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India.
In this study, participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine.
The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety.
"This publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data. It highlights our continued commitment to providing affordable, effective, and accessible vaccines for the populations who need them the most,” said Dr. Krishna Ella, Executive Chairman of Bharat Biotech.
Dr. Ella added , “Cholera is a vaccine-preventable disease that has faced a surge in outbreaks along with a huge shortage of vaccines. The new generation Oral Cholera Vaccine Hillchol, featuring a simplified single stable O1 Hikojima strain, inducing robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.”
Cholera is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria. Studies have estimated that 2.86 million cases and 95,000 deaths occur annually.
Global demand for OCVs is close to 100 million doses a year, and given that only one manufacturer supplies them, there is a global shortage. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have a capacity to produce up to 200 million doses of Hillchol.
Reference: Krishna Mohan Vadrevu, Abhishek Chavan, Amit Chawla, B.S. Chakravarthy, Chandramani Singh, Sagar Redkar, Savita Verma, Sriharsha Yandapally, M. Suma Priya, Vasant Khalatkar, Vishal Tripathi, Brunda Ganneru, Siddharth Reddy, Bhargav Reddy, Jan Holmgren, Badri Patnaik, Sai D. Prasad, Raches Ella, A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol™, Vaccine, https://doi.org/10.1016/j.vaccine.2025.126998.
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