Vizag's King George Hospital among 10 centres in country to participate in oral cholera vaccine trials
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Of the 1,800 enrolled participants across these 10 sites, 1,794 completed the clinical study, which assessed the safety, immunogenicity, and non-inferiority of Hillchol in comparison to a comparator vaccine in this diverse participant group. Post-vaccination, the percentage of participants in the Hillchol group who exhibited a four-fold increase in anti-Vibrio cholerae antibody titres was 68.25% for Ogawa and 69.52% for Inaba.
For the uninformed, among the various serotypes of the Vibrio cholerae O1 biotype, Ogawa and Inaba are primarily associated with cholera outbreaks, as they exhibit distinct antigenic variations in their lipopolysaccharide structure. Cholera is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria.
Approximately, V. cholerae affects 1.3 to 4.0 million people per year, causing between 21,000 and 1.43 lakh deaths worldwide, predominantly in developing nations across Africa, Asia, and the Americas.
Children under five years of age account for about half of all cases and deaths, although individuals of all ages are susceptible.
The World Health Organisation (WHO) recently reported that the dynamics of cholera outbreaks are becoming increasingly complex, with a rise in the number of cases since 2021, highlighting the escalating challenge of controlling V. cholerae infections and transmission.
The global demand for OCVs is close to 100 million doses per year.
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Yet, given that only a single manufacturer supplies them, a global shortage persists. According to Bharat Biotech, its facilities in Hyderabad and Bhubaneswar have the capacity to produce up to 200 million doses of Hillchol. The new-generation OCV, featuring a simplified single stable O1 Hikojima strain, aims to enhance production efficiency and affordability.
It induces robust antibodies against both Ogawa and Inaba serotypes, improving accessibility, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.
A total of 1,800 participants were screened based on health status across the 10 trial sites to ensure a diverse demographic analysis. Participants with a history of cholera vaccination or infection, hypersensitivity to past vaccinations, immune disorders, significant acute symptoms, or recent treatment for diarrhoea were excluded. All trial sites were tertiary care centres, including KGH Visakhapatnam, located in urban areas.
Participants were enrolled after obtaining informed consent. The other centres were located in states such as Maharashtra, Telangana, Uttar Pradesh, Goa, and Bihar.
The trial achieved a completion rate of 99% (1,782 participants), with a discontinuation rate of 1% attributed to various reasons. No serious adverse events were reported, with the majority of adverse events being mild. According to the researchers, this highlights the safety of the vaccine as a viable OCV option and the reliability of its manufacturing processes. Its scalability and logistical benefits also highlight its potential to mitigate the OCV shortage.
The study findings have been published in Vaccine, a journal from ScienceDirect.
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