Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

Hyderabad: Bharat Biotech ’s oral cholera vaccine , Hillchol , has demonstrated positive results in a Phase-3 trial against the two serotypes of the disease—Ogawa and Inaba—in healthy Indian adults and children. The vaccine’s potential efficacy was reported in a double-blind, randomised Phase III clinical trial designed to evaluate safety, immunogenicity , non-inferiority, and lot-to-lot consistency, in comparison to a comparator vaccine. The trial results, published in ScienceDirect’s Vaccine journal, noted, “Hillchol demonstrated a greater than four-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes.” In addition, “the investigational vaccine was well-tolerated and immunogenic across all age groups—including infants (≥1 year), children, and adults.” Participants in the study were divided into three age groups and were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine. The trial included a diverse cohort of 1,800 participants, from infants to adults, across 10 clinical sites in India. The primary endpoint was the proportion of participants achieving a >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. “The new-generation oral cholera vaccine Hillchol, featuring a simplified, single, stable O1 Hikojima strain that induces 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.” Explaining the vaccine’s mechanism, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, said, “The vaccine, featuring a simplified single stable O1 Hikojima strain, induces robust antibodies against both Ogawa and Inaba serotypes.” He added, “This publication reaffirms our commitment, and we aim to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Cholera is an acute diarrheal infection caused by ingesting food or water contaminated with the bacterium Vibrio cholerae. Two serogroups—O1 (with subtypes Ogawa and Inaba) and O139—are responsible for cholera outbreaks . Transmission typically occurs through the fecal-oral route, primarily via contaminated food or water. Bharat Biotech’s vaccine was tested against Shanchol, a comparator vaccine previously marketed by Shantha Biotechnics, which is no longer in production. Shantha Biotechnics, a wholly owned subsidiary of French drugmaker Sanofi, discontinued the oral vaccine in 2023. The only other currently available option is Euvichol-S, marketed by EuBiologics Co., Ltd., and prequalified by the World Health Organization (WHO) for use in countries facing cholera outbreaks. According to Bharat Biotech, global demand for oral cholera vaccines (OCVs) is estimated at 100 million doses annually, but there is a significant shortage, with only one major supplier currently meeting global needs. Bharat Biotech’s facilities in Hyderabad and Bhubaneswar have the capacity to produce up to 200 million doses of the vaccine, positioning India as a key player in tackling the global cholera burden. By Online Bureau ,