The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants

Vaccine
Amit SahaFirdausi Qadri

Abstract

The oral cholera vaccine (OCV), Shanchol™ has shown protective efficacy lasting up to 5 years, however, requirement for a cold chain limits its use in resource poor settings. The study was conducted to determine the safety and immunogenicity of Shanchol in adult participants in Bangladesh when stored at elevated temperatures. The study was conducted in Mirpur, Dhaka. Four groups of healthy adult participants received two doses of Shanchol™, kept under standard storage temperature (Group A; 2-8°C) or at elevated temperatures (Group B, 25°C; Group C, 37°C; Group D, 42°C) for 14 days, respectively. Vaccine specific antibody responses were determined. 145 participants were assigned to each group. Adverse events were mild not differing among groups. Vaccine stored at elevated temperatures remained stable with cumulative LPS content within admissible limits. Vibriocidal antibody responses were observed in all groups after each dose of vaccine at day 7 and 21 compared to pre-immune levels (P<0.001). Four-fold increases to Vibrio cholerae O1 Ogawa were observed at day 7 and/or day 21 after vaccination in the standard temperature and the three elevated temperature groups, with responder rates of; 76% (95% CI LB; 70%), 80% (95% CI LB; 74...Continue Reading

Associated Clinical Trials

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Citations

Nov 5, 2016·Human Vaccines & Immunotherapeutics·Sachin N DesaiDominique Legros
Dec 6, 2016·Vaccine·Francisco J LuqueroDavid A Sack
Nov 3, 2016·Expert Review of Vaccines·Amit SahaFirdausi Qadri
Jul 27, 2018·Current Opinion in Infectious Diseases·Ana A Weil, Edward T Ryan
Sep 22, 2018·The Journal of Infectious Diseases·Iza CigleneckiJean-Clement Cabrol
Dec 7, 2018·Bulletin of the World Health Organization·Francesco GrandessoSandra Cohuet
Mar 11, 2017·Artificial Cells, Nanomedicine, and Biotechnology·Mahdi Fasihi-RamandiKazem Ahmadi
Sep 1, 2018·The Journal of Infectious Diseases·Md Taufiqul IslamFirdausi Qadri
May 10, 2017·Bulletin of the World Health Organization·Amber HsiaoLaura Digilio
Dec 17, 2016·Emerging Infectious Diseases·Eugene LamKashmira Date
Feb 27, 2019·BMC Proceedings·Mesbah Uddin AhmedG Balakrish Nair
Sep 6, 2018·The Journal of Infectious Diseases·Jason B Harris
Apr 4, 2021·Tropical Medicine and Infectious Disease·Jacqueline Deen, John D Clemens
Nov 16, 2021·Expert Review of Vaccines·James McCartyDouglas Haney

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