Bharat Biotech's cholera vaccine successfully completes Phase-III trials
International Ltd on Wednesday said its
oral Cholera Vaccine
Hillchol has successfully completed phase III clinical trials. The vaccine maker, in a press release, said it has demonstrated against both Ogawa and Inaba serotypes, proving non-inferior in healthy Indian adults and children, supporting its potential as an effective OCV.
Ogawa and Inaba are two serotypes of Vibrio cholerae O1, a bacterial species that causes cholera.
The findings of a double-blind, randomized phase III clinical trial evaluating the safety, immunogenicity, non-inferiority, and lot-to-lot consistency of the
Hillchol
oral cholera vaccine, compared to a comparator vaccine, were recently published in a journal. The study involved 1,800 participants, ranging from infants to adults, across 10 clinical sites in India, the release said.
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The participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine.
"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 Krishna Ella, Executive Chairman of Bharat Biotech.
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Cholera is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria. Studies have estimated that 2.86 million cases and 95,000 deaths occur annually, the release further said.
Global demand for OCVs is close to 100 million doses a year, and given that only one manufacturer supplies them, there is a global shortage. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have a capacity to produce up to 200 million doses of Hillchol, it added.
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