New Oral Cholera Vaccine by Bharat Biotech Passes Phase III Clinical Trial: Study

New Delhi: Bharat Biotech announced that its oral cholera vaccine, Hillchol, has successfully completed Phase III clinical trials, demonstrating high efficacy against both Ogawa and Inaba serotypes of cholera. The findings have been published in the Vaccine journal. The vaccine showed a more than four-fold rise in vibriocidal antibodies—68.3% for Ogawa and 69.5% for Inaba—and was found to be non-inferior to currently licensed vaccines. It also exhibited a strong safety profile with only mild adverse events reported across all age groups.

Currently, global demand for oral cholera vaccines is around 100 million doses per year, but supply is limited due to dependence on a single manufacturer, leading to periodic shortages.

Cholera, a severe diarrheal illness caused by ingesting water or food contaminated with Vibrio cholerae, is responsible for an estimated 2.86 million cases and 95,000 deaths globally each year.

The double-blind, randomized Phase III trial evaluated Hillchol’s safety, immunogenicity, non-inferiority, and lot-to-lot consistency in comparison with the existing vaccine Shanchol. Conducted across 10 clinical sites in India, the study involved 1,800 participants ranging from infants to adults. The subjects were grouped into three categories: infants (1 to under 5 years), children (5 to under 18 years), and adults (18 years and above) and were randomized in a 3:1 ratio to receive either Hillchol or the comparator vaccine.

Highlighting the vaccine’s potential global impact, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, stated, “The new generation oral cholera vaccine features a simplified single stable O1 Hikojima strain, which enhances production efficiency and affordability and is particularly beneficial for lower- and middle-income countries.” He said the company’s facilities in Hyderabad and Bhubaneswar are equipped to produce 200 million doses of Hillchol and can ease the global shortage of oral cholera vaccines.

The successful trial positions Hillchol as a solution to help bridge the global vaccine supply gap and combat cholera outbreaks effectively, especially in vulnerable populations.

Reference: Vadrevu, K. M., Chavan, A., Chawla, A., Chakravarthy, B. S., Singh, C., Redkar, S., ... & Ella, R. (2025). 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, 55, 126998.