Vaccine maker Bharat Biotech announced on Wednesday that its oral cholera vaccine, Hillchol, has successfully completed phase III clinical trials. This double-blind, randomized trial evaluated the vaccine’s safety, immunogenicity, non-inferiority, and lot-to-lot consistency. The study involved 1,800 participants ranging from infants to adults across ten clinical sites in India. The primary endpoint was to determine the proportion of participants achieving a greater than four-fold increase in vibriocidal antibody titres against the Ogawa and Inaba serotypes 14 days after receiving two doses. Secondary endpoints included Geometric Mean Titre (GMT) measurements and safety assessments.
According to Bharat Biotech, Hillchol showed a greater than four-fold increase in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes, demonstrating non-inferiority to licensed vaccines. This result supports Hillchol’s potential as an effective oral cholera vaccine, as detailed in the study published in the Vaccine journal on ScienceDirect. Adverse events associated with the vaccine were mild and comparable to those of the comparator vaccine, Shanchol. The vaccine was well-tolerated and immunogenic across all age groups, including infants, children, and adults, indicating readiness for distribution within the coming months.
Krishna Ella, Executive Chairman of Bharat Biotech, emphasized the company’s commitment to advancing vaccines through rigorous research and comprehensive clinical trials. He noted that this publication reflects their dedication to providing affordable, effective, and accessible vaccines to populations in need. Cholera, a vaccine-preventable disease, has experienced a surge in outbreaks alongside a global vaccine shortage. Hillchol utilizes a simplified single stable O1 Hikojima strain, aiming to enhance production efficiency and affordability, especially in lower- and middle-income countries where waterborne diseases remain a serious health threat.
The global demand for oral cholera vaccines (OCVs) approaches 100 million doses annually, but with only one manufacturer currently supplying the market, there is a significant shortage. Bharat Biotech’s facilities in Hyderabad and Bhubaneswar can produce up to 200 million doses of Hillchol. The vaccine, known by its trade name BBV131, has already received market authorization in India.
Original Source: https://www.thehindu.com/news/cities/Hyderabad/phase-iii-clinical-trials-of-bharat-biotechs-oral-cholera-vaccine-over/article69602317.ece
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Publish Date: 2025-05-21 20:25:00
