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Hyderabad-based Bharat Biotech International Ltd. has claimed that its oral cholera vaccine (OCV) under development, Hillchol, has shown promising results in final Phase III clinical trials.
The results of its clinical trial, published in the journal Vaccine (ScienceDirect), indicate that Hillchol demonstrated efficacy against both Ogawa and Inaba serotypes, proving non-inferior
in healthy Indian adults and children. These findings support its potential as an effective OCV.
The double-blind, randomised phase III clinical trial was conducted to evaluate the safety, immunogenicity, non-inferiority, and lot-to-lot consistency of the single-component OCV Hillchol,
in comparison to a comparator vaccine. The study was conducted on a diverse participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India.
According to a statement issued by the company, Hillchol demonstrated a greater than fourfold rise in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes,
establishing its non-inferiority to licensed vaccines. The statement also noted that adverse events were mild and comparable between Hillchol and the comparator vaccine, supporting its
favourable safety profile.
"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, Bharat Biotech.
“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”, he adds.
Cholera is an acute diarrhoeal infection caused by the ingestion of food or water contaminated with Vibrio cholerae bacteria. Studies estimate that it causes approximately 2.86 million cases
and 95,000 deaths globally each year.
Global demand for OCVs is estimated at nearly 100 million doses annually. However, with only one manufacturer currently supplying them, there is a global shortage. Bharat Biotech stated that
its facilities in Hyderabad and Bhubaneswar have the capacity to produce up to 200 million doses of Hillchol.
Privately held Bharat Biotech is one of India’s leading vaccine manufacturers, with a product portfolio comprising over 19 vaccines, four biotherapeutics, registrations in more than 125
countries, and multiple World Health Organisation (WHO) pre-qualifications.