Latest news with #BharatBiotech
Time of India
3 days ago
- Health
- 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
5 days ago
- Health
- 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
Time of India
7 days ago
- Health
- Time of India
Bharat Bio completes Phase III trials of new oral cholera vaccine Hillchol
Hyderabad: Vaccine maker Bharat Biotech on Wednesday said its oral cholera vaccine, Hillchol, successfully completed Phase III clinical trials demonstrating efficacy against both Ogawa and Inaba serotypes. Tired of too many ads? go ad free now The Hyderabad-based vaccine maker said Hillchol showed an over four-fold rise in vibriocidal antibodies—68.3% for Ogawa and 69.5% for Inaba serotypes. The vaccine proved non-inferior to licensed vaccines and maintained a strong safety profile across all age groups, with only mild adverse events reported, it added. The findings of the study have been published in the ScienceDirect vaccine journal. The double-blind, randomised Phase III clinical trial was conducted to evaluate the safety, immunogenicity, non-inferiority, and lot-to-lot consistency of the single-component Hillchol in comparison to a comparator vaccine, Shanchol, in a diverse group of 1,800 individuals, ranging from infants to adults, across 10 clinical sites in India. The 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. The participants were randomised in a ratio of 3:1 to receive either Hillchol or a comparator vaccine. Pointing to the significant role Hillchol can play in addressing the global cholera crisis and vaccine shortages, Bharat Biotech executive chairman Dr Krishna Ella said the new generation oral cholera vaccine features a simplified single stable O1 Hikojima strain, which enhances production efficiency and affordability and is particularly beneficial for lower- and middle-income countries. He said the company's facilities in Hyderabad and Bhubaneswar are equipped to produce 200 million doses of Hillchol and can ease the global shortage of oral cholera vaccines. While currently the global demand for oral cholera vaccines is around 100 million doses per annum, there is only one manufacturer. Cholera, which is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria, is estimated to cause over 2.86 million cases and around 95,000 deaths globally every year.
Hans India
22-05-2025
- Health
- Hans India
Bharat Biotech's oral cholera vax clears phase-3 trials: Study
Hyderabad: Bharat Biotech, which has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 19 vaccines, 4 biotherapeutics, has made a significant announcement. Its oral cholera vaccine (OCV) 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 above 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. 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 as follows: Robust Immunogenicity: 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; and, Strong Safety Profile: Adverse events were mild and comparable between the two vaccines. Broad Age Coverage: The vaccine was well-tolerated and immunogenic across all age groups—including infants (≥1 year), children, and adults. '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 Dr Krishna Ella, Executive Chairman, Bharat Biotech. Dr Ella added, '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.' As cholera continues to threaten communities lacking clean water and sanitation, Hillcholprovides a streamlined, scalable solution designed to support global health programmes and ensure equitable access to life-saving 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.
Time of India
21-05-2025
- Health
- Time of India
Bharat Bio successfully completes Phase III trials of new oral cholera vaccine Hillchol
Dr Krishna Ella executive chairman Bharat Biotech HYDERABAD: Vaccine maker Bharat Biotech on Wednesday said its oral cholera vaccine , Hillchol , successfully completed Phase III clinical trials demonstrating efficacy against both Ogawa and Inaba serotypes . The Hyderabad-based vaccine maker said Hillchol showed an over four-fold rise in vibriocidal antibodies—68.3% for Ogawa and 69.5% for Inaba serotypes. The vaccine proved non-inferior to licensed vaccines and maintained a strong safety profile across all age groups, with only mild adverse events reported, it added. The findings of the study have been published in the ScienceDirect vaccine journal. The double-blind, randomised Phase III clinical trial was conducted to evaluate the safety, immunogenicity, non-inferiority, and lot-to-lot consistency of the single-component Hillchol in comparison to a comparator vaccine (Shanchol) in a diverse group of 1,800 individuals, ranging from infants to adults, across 10 clinical sites in India. The 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. The participants were randomised in a ratio of 3:1 to receive either Hillchol or a comparator vaccine. Pointing to the significant role Hillchol can play in addressing the global cholera crisis and vaccine shortages, Bharat Biotech executive chairman Dr Krishna Ella said the new generation oral cholera vaccine features a simplified single stable O1 Hikojima strain, which enhances production efficiency and affordability and is particularly beneficial for lower- and middle-income countries. He said the company's facilities in Hyderabad and Bhubaneswar are equipped to produce 200 million doses of Hillchol and can ease the global shortage of oral cholera vaccines. While currently the global demand for oral cholera vaccines is around 100 million doses per annum , there is only one manufacturer, resulting in shortages. Cholera, which is an acute diarrhoeal infection caused by ingesting food or water contaminated with vibrio cholerae bacteria, is estimated to cause over 2.86 million cases and around 95,000 deaths globally every year. Bharat Biotech, which has delivered over nine billion doses of vaccines globally so far, has over 145 global patents and a portfolio of over 19 vaccines, four biotherapeutics and registrations in over 125 countries. Apart from developing India's first indigenous Covid-19 vaccine Covaxin , it has also developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (Jenvac), Rabies, Chikungunya, Zika, and the world's first tetanus-toxoid conjugated vaccine for Typhoid.
