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Time of India
24-05-2025
- 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.
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.
Time of India
21-05-2025
- Health
- Time of India
Bharat Biotech successfully completes Phase III trials of new oral cholera vaccine Hillchol
Bharat Biotech successfully completes Phase III trials of new oral cholera vaccine Hillchol (Picture credit: X/@BharatBiotech) 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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Estrénalo con hasta 10 años de garantía Nuevo Nissan Juke Ver oferta Undo 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. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
The Hindu
21-05-2025
- Health
- The Hindu
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.
