Bharat Biotech's oral cholera vaccine Hillchol clears phase 3 trials

Bharat Biotech, the makers of Covaxin, on Tuesday said that their oral cholera vaccine Hillchol has demonstrated against both the Ogawa and Inaba serotypes of Cholera in both adults and children in a phase 3 clinical study across 1800 individuals. 

 

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," the company said. Sanofi India makes an oral cholera vaccine 

 

The double-blind, randomised phase 3 clinical trial was evaluating safety, immunogenicity and non-inferiority as well as a lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in an 1800 participant study 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 above study findings have been published in the ScienceDirect, Vaccine journal. The primary endpoint focused on the proportion of participants achieving  over 4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. 

 

Bharat Biotech claimed that Hillchol demonstrated 4-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes, proving non-inferiority to licensed vaccines. It also demonstrated a strong safety profile and was well-tolerated across all age groups including infants less than 1 year old.  

"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 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.”