Cholera, a severe diarrhoeal disease from contaminated food or water, causes 2.86 million cases and 95,000 deaths annually. Global vaccine demand exceeds 100 million doses, but supply remains limited
Published May 22, 2025 | 12:53 AM ⚊ Updated May 22, 2025 | 8:27 AM
Synopsis: In a major advance against cholera, Hyderabad-based Bharat Biotech’s oral vaccine Hillchol has completed successful Phase III trials. The study confirmed its safety, strong immune response, and effectiveness across age groups against Ogawa and Inaba serotypes. Conducted at 10 Indian sites with 1,800 participants, the trial showed Hillchol’s performance was non-inferior to existing vaccines, marking a milestone in public health efforts
In a significant breakthrough in the fight against cholera, Hyderabad based Bharat Biotech’s oral cholera vaccine Hillchol has successfully completed Phase III clinical trials, demonstrating strong safety, immunogenicity, and non-inferiority to existing licensed vaccines. The results, published in the journal Vaccine (ScienceDirect, Article ID: 126998), show Hillchol’s effectiveness against both Ogawa and Inaba serotypes of Vibrio cholera across diverse age groups.
The randomized, double-blind, controlled Phase III study involved 1,800 participants across 10 clinical sites in India—ranging from infants aged 1 to under 5 years, children aged 5 to under 18, to adults above 18. Participants were randomized in a 3:1 ratio to receive either Hillchol or a comparator oral cholera vaccine (OCV).
The trial’s primary goal was to assess the proportion of participants achieving a more than four-fold rise in vibriocidal antibodies 14 days after two doses. Hillchol met this endpoint successfully, showing immunogenicity rates of 68.3 percent for the Ogawa serotype and 69.5 percent for Inaba—demonstrating non-inferiority to the comparator vaccine. Geometric Mean Titres (GMTs) and safety outcomes were included as secondary endpoints.
“This publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data,” said Dr. Krishna Ella, Executive Chairman of Bharat Biotech in a statement. “Hillchol is a new-generation OCV built on a simplified, stable O1 Hikojima strain that induces robust antibody responses, making it an affordable and scalable solution for countries that continue to struggle with cholera outbreaks.”
Dr. Ella emphasized that cholera, a vaccine-preventable disease, still affects millions globally due to poor water and sanitation access—particularly in low- and middle-income countries. “With outbreaks surging and a severe global vaccine shortage, Hillchol could play a critical role in filling the gap,” he added.
Cholera, caused by ingestion of contaminated food or water, results in acute diarrhoeal illness and remains a major public health threat in many regions. The World Health Organization estimates around 2.86 million cases and 95,000 deaths from cholera each year. Current global demand for oral cholera vaccines is estimated at over 100 million doses annually, but supply is limited due to dependence on a single manufacturer.
With manufacturing facilities in Hyderabad and Bhubaneswar, Bharat Biotech claims it can produce up to 200 million doses of Hillchol annually, positioning the company to significantly alleviate the global supply crunch.
Hillchol’s Phase III success not only strengthens Bharat Biotech’s growing portfolio of public health vaccines but also enhances India’s position in the global fight against infectious diseases through indigenous innovation and large-scale vaccine manufacturing.
