Phase III clinical trials of Bharat Biotech's oral cholera vaccine over
Vaccine maker Bharat Biotech on Wednesday said its oral cholera vaccine Hillchol has successfully completed phase III clinical trials.
The double-blind, randomised phase III clinical trial was to evaluate safety, immunogenicity, non-inferiority and lot-to-lot consistency of single component of the OCV in comparison to a comparator vaccine (Shanchol) in a participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India.
The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. Secondary endpoints included Geometric Mean Titre (GMT) measurements and safety.
'Hillchol demonstrated a greater than 4-fold rise in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes, proving non-inferiority to licensed vaccines... supporting its potential as an effective OCV,' Bharat Biotech said in a release on the study findings published in the Vaccine journal ScienceDirect.
Paves way for distribution
Adverse events were mild and comparable between the two vaccines. The vaccine was well-tolerated and immunogenic across all age groups — including infants, children, and adults. The trials pave the way for distribution of Hillchol within the next few months, it said.
'The publication [of the study] 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,' Executive Chairman Krishna Ella said.
Cholera is a vaccine-preventable disease that faced a surge in outbreaks along with a huge shortage of vaccines. Hillchol features a simplified single stable O1 Hikojima strain. It aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats, he said.
Global demand for OCVs is close to 100 million doses a year. 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, the company said.
BBV131 - trade name Hillchol – has received market authorisation in India.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
3 days ago
- Time of India
Musi river water unfit for drinking except at Osman Sagar: Study
Hyderabad: A scientific study published in the June edition of the Cleaner Water journal by ScienceDirect has found that water from the Musi River is unfit for drinking at all locations except at its upstream source, Osman Sagar. Tired of too many ads? go ad free now The research, titled 'Spatial and Seasonal Assessment of Water Quality of Musi River, India,' was led by Ajmal Koya Pulikkal of the Department of Chemistry, National Institute of Technology Mizoram, and co-authored by Mohammad Zakwan from Maulana Azad National Urdu University, Hyderabad. Water samples were collected from four stations — Osman Sagar (upstream), Bapughat and Musarambagh (midstream), and Nagole (downstream) — during the pre-monsoon, monsoon, and post-monsoon seasons. The study analysed 27 water quality parameters using standard methods and indices such as the Weighted Arithmetic Water Quality Index (WAWQI), Nemerow's Pollution Index, and various irrigation indices. The WAWQI values across the sites showed a sharp deterioration in water quality downstream: 38 at Osman Sagar, 175 at Bapughat, 197 at Musarambagh, and 179 at Nagole. Only Osman Sagar met the Bureau of Indian Standards for potable water. The deterioration became significant at Bapughat, attributed to urban encroachments, waste dumping, and sewage discharge. The study noted a slight improvement in water quality at Nagole, likely due to the Amberpet sewage treatment plant near Musarambagh. Seasonal and irrigation assessment reflect pollution load Seasonal analysis revealed further insights. While water from Osman Sagar remained suitable for both drinking and irrigation in all seasons (S-1 category), the other stations fell into S-3 (unsuitable for irrigation) during the pre and post-monsoon periods, and into S-2 (moderately suitable) during the monsoon, due to dilution effects. Tired of too many ads? go ad free now Kelley's index also indicated that only Osman Sagar's water was suitable for irrigation throughout the year. The study flagged declining dissolved oxygen levels and rising biochemical oxygen demand downstream. Hydrochemical facies analysis (a method used to interpret the chemical composition of water) using Piper diagrams further revealed a shift in water composition from upstream to downstream. The authors call for urgent and consistent monitoring, improved wastewater treatment, effective stormwater management, and stronger environmental regulation to reverse the degradation.
Time of India
28-05-2025
- Time of India
Vizag's King George Hospital among 10 centres in country to participate in oral cholera vaccine trials
Visakhapatnam: King George Hospital in Visakhapatnam is one of 10 centres in the country that participated in phase III trials of oral cholera vaccine Hillchol, developed by Bharat Biotech. Tired of too many ads? go ad free now 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. Tired of too many ads? go ad free now 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.
United News of India
26-05-2025
- United News of India
Bharat Biotech's oral cholera vaccine Hillchol demonstrates success in Phase III
Hyderabad, May 21 (UNI) Bharat Biotech's Oral Cholera Vaccine Hillchol has demonstrated against both Ogawa and Inaba serotypes, proving non-inferior in healthy Indian adults and children, supporting its potential as an effective OCV. The study findings have been published in the ScienceDirect, Vaccine journal 126998 to assess a double-blind, randomized phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in a diverse participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India, Hyderabad based Vaccine maker said in a release here on Wednesday. In this study, 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. The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety. Key highlights from the findings are that Hillchol demonstrated a greater than 4-fold rise in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes, proving non-inferiority to licensed vaccines. Adverse events were mild and comparable between the two vaccines. The vaccine was well-tolerated and immunogenic across all age groups—including infants (≥1 year), children, and adults. Dr. Krishna Ella, Executive Chairman of Bharat Biotech, said, " T his publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data." 'Cholera is a vaccine-preventable disease that has faced a surge in outbreaks along with a huge shortage of vaccines. The new generation Oral Cholera Vaccine Hillchol, featuring a simplified single stable O1 Hikojima strain, inducing robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats," Dr Ella added. 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. With Hillchol, Bharat Biotech strengthens its commitment to combating global infectious diseases through innovation and clinical excellence. As cholera continues to threaten communities lacking clean water and sanitation, Hillchol provides a streamlined, scalable solution designed to support global health programs and ensure equitable access to life-saving vaccines. 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. UNI KNR BM
