The phase I/II clinical study was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh
Hilleman Laboratories has successfully completed the phase I/II clinical trials of its novel oral cholera vaccine Hillchol to address growing need to stop cholera in the developing world. The phase I/II clinical study was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). Results of the clinical trials were announced at the Vaccines for Enteric Diseases Conference 2017 recently held in Albufeira, Portugal.
Sharing results of the clinical study, Dr Ajit Pal Singh, VP Clinical R&D, Hilleman Labs stated, “Hillchol was tested in 840 subjects that included adults, adolescents as well as small children. We were able to demonstrate safety and tolerability of Hillchol in our phase I/II trials. Our vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes. When compared against Shanchol, the cholera vaccine pre-qualified by WHO, we could achieve non-inferiority in terms of seroconversion as well as Geometric Mean Titre for both the Ogawa and Inaba serotypes. These results are encouraging and warrant further development of our Cholera vaccine.”
Dr Tarun Sharma, Director R&D, Hilleman Labs stated, “The Hillchol Phase I/II clinical trial results support our Hikojima vaccine design and mirror the impressive results we have been able to achieve in preclinical studies. This encourages us to conduct further clinical studies as well as undertake further research in our labs for additional innovations in next-generation oral cholera vaccines.”
Talking about the accomplishment, Dr Davinder Gill, CEO Hilleman Laboratories said, “There is an urgent need for effective and affordable cholera vaccines for use in both cholera outbreaks and in mass vaccination campaigns. Currently, WHO recommends oral cholera vaccines for humanitarian crises and in outbreaks. With the advancement of Hillchol, we hope to make available to the global health community, an affordable vaccine for mass vaccination in hotspots against cholera-endemic countries. This will greatly assist in the global initiative recently announced by WHO to reduce cholera deaths by 90 per cent by the year 2030.”