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.
