Bharat Biotech’s oral cholera vaccine, Hillchol®, has demonstrated strong immunogenicity against both Ogawa and Inaba serotypes of Vibrio cholerae, proving non-inferior to licensed vaccines. The findings, published in the ScienceDirect journal Vaccine (Article 126998), confirm the vaccine’s potential as a reliable and effective oral cholera vaccine (OCV) for diverse age groups in India.
Robust Phase III Trial Design Across Age Groups
As per the Bharat Biotech’s press release, the company conducted a double-blind, randomized Phase III clinical trial involving 1,800 participants—ranging from infants to adults—across 10 clinical sites in India. Participants were divided into three age groups:
- Adults (over 18 years)
- Children (5 to under 18 years)
- Infants (1 to under 5 years)
Researchers randomized the participants in a 3:1 ratio to receive either Hillchol® or a comparator vaccine (Shanchol).
Primary and Secondary Endpoints
The trial’s primary endpoint assessed the proportion of participants achieving more than a four-fold increase in vibriocidal antibody titres against the Ogawa and Inaba serotypes 14 days after two doses. Secondary endpoints included geometric mean titres (GMTs) and evaluation of safety.
Key Findings: Hillchol®’s Efficacy and Safety
- Robust Immunogenicity: Hillchol® achieved a >4-fold rise in antibody titres in 68.3% (Ogawa) and 69.5% (Inaba) of participants, demonstrating non-inferiority to existing vaccines.
- Strong Safety Profile: Adverse events were mild and comparable to those in the comparator group.
- Broad Age Coverage: The vaccine was well-tolerated and effective across all age groups, including infants, children, and adults.
A Step Toward Affordable, Scalable Cholera Prevention
Dr. Krishna Ella, Executive Chairman of Bharat Biotech, emphasized the vaccine’s importance amid global cholera outbreaks and vaccine shortages. “This publication reaffirms our commitment to rigorous science and delivering vaccines that are both effective and accessible,” he stated.
He added, “Cholera remains a vaccine-preventable disease, yet outbreaks persist due to poor sanitation and vaccine scarcity. Hillchol® is built with a simplified, single stable O1 Hikojima strain. This design enhances both production efficiency and affordability, making it especially valuable for low- and middle-income countries.”
Meeting Global Vaccine Demand Through Scalable Manufacturing
Global demand for oral cholera vaccines stands at approximately 100 million doses per year, yet a single manufacturer currently supplies this demand, resulting in chronic shortages. Bharat Biotech has stepped in to bridge this gap. With manufacturing facilities in Hyderabad and Bhubaneswar, the company can produce up to 200 million doses of Hillchol® annually.
Fighting Cholera with Innovation and Commitment
Cholera, an acute diarrhoeal disease caused by contaminated food or water, leads to an estimated 2.86 million cases and 95,000 deaths globally every year. Bharat Biotech, through Hillchol®, reinforces its mission to combat infectious diseases with innovative, evidence-based solutions. This new generation OCV supports global health programs and ensures equitable access to life-saving vaccines in high-risk communities.