Conduct trial with additional safety arm of 1800 subjects: CDSCO Panel Tells Bharath Biotech on Cholera Vaccine
New Delhi: Regarding the already approved Phase III clinical trial protocol of Cholera Vaccine (Inactivated Vibrio cholarae, MS 1568, Oral), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the vaccine maker Bharat Biotech to conduct the trial with additional safety arm of 1800 subjects.
Cholera is an acute diarrhoeal infection caused by ingestion of food or water contaminated with the bacterium Vibrio cholerae. Cholera is an easily treatable disease. The majority of people can be treated successfully through prompt administration of oral rehydration solution (ORS). Currently there are three WHO pre-qualified oral cholera vaccines (OCV): Dukoral, Shanchol, and Euvichol-Plus. All three vaccines require two doses for full protection.
Bharat Biotech International Limited is conducting a Phase III randomised, modified double-blind, multi-centric, comparative study to assess the non-inferiority of immunogenicity, safety, and lot-to-lot consistency of the single strain oral cholera vaccine Hillchol (BBV131) to the comparator vaccine Shanchol.
Prior to that, Bharat Biotech International Ltd. and Hilleman Laboratories, a global organisation for vaccine research and development, collaborated together to manufacture Hillchol, a new oral cholera vaccine.
At the recent SEC meeting for Vaccine, the expert panel reviewed the proposal presented by vaccine major Bharat Biotech for the inclusion of an additional safety arm of 1800 subjects as an addendum to the already approved Phase III clinical trial protocol of Cholera Vaccine (Inactivated Vibrio cholerae, MS1568, Oral).
