Yeong Ok Baik1, Seuk Keun Choi1, Remigio M Olveda2, Roberto A Espos3, Antonio D Ligsay4, May B Montellano5, Jong Sun Yeam6, Jae Seung Yang7, Ju Yeon Park8, Deok Ryun Kim8, Sachin N Desai8, Ajit Pal Singh8, Ick Young Kim9, Chan Wha Kim9, Sue-nie Park10. 1. EuBiologics Co., Ltd., Seoul, Republic of Korea; Department of Biotechnology, Korea University, Seoul, Republic of Korea. 2. Research Institute for Tropical Medicine, Muntinlupa City, Philippines. 3. De Lasalle University Medical Center, Dasmarinas, Philippines. 4. National Children's Hospital, Quezon, Philippines. 5. Mary Chiles General Hospital, Manila, Philippines. 6. EuBiologics Co., Ltd., Seoul, Republic of Korea. 7. Clinical Immunology, Laboratory Science Unit, International Vaccine Institute (IVI), Seoul, Republic of Korea. 8. Development and Delivery, International Vaccine Institute (IVI), Seoul, Republic of Korea. 9. Department of Biotechnology, Korea University, Seoul, Republic of Korea. 10. EuBiologics Co., Ltd., Seoul, Republic of Korea. Electronic address: suenie@eubiologics.com.
Abstract
BACKGROUND: Currently, there are two oral cholera vaccines (OCV) that are prequalified by the World Health Organization. Both (Dukoral and Shanchol) have been proven to be safe, immunogenic, and effective. As the global supply of OCV remains limited, we assessed the safety and immunogenicity of a new low cost, killed, bivalent OCV (Euvichol) in the Philippines. METHODS: The randomized controlled trial was carried out in healthy Filipino adults and children. Two doses of either the current WHO prequalified OCV (Shanchol) or the same composition OCV being considered for WHO prequalification (Euvichol) were administered to participants. RESULTS: The pivotal study was conducted in total of 1263 healthy participants (777 adults and 486 children). No serious adverse reactions were elicited in either vaccine groups. Vibriocidal antibody responses to V. cholerae O1 Inaba following administration of two doses of Euvichol were non-inferior to those of Shanchol in adults (82% vs 76%) and children (87% vs 89%). Similar findings were observed for O1 Ogawa in adults (80% vs 74%) and children (91% vs 88%). CONCLUSION: A two dose schedule with Euvichol induces a strong vibriocidal response comparable to those elicited by the currently WHO prequalified OCV, Shanchol. Euvichol will be an oral cholera vaccine suitable for use in lower income countries, where cholera still has a significant economic and public health impact.
RCT Entities:
BACKGROUND: Currently, there are two oral cholera vaccines (OCV) that are prequalified by the World Health Organization. Both (Dukoral and Shanchol) have been proven to be safe, immunogenic, and effective. As the global supply of OCV remains limited, we assessed the safety and immunogenicity of a new low cost, killed, bivalent OCV (Euvichol) in the Philippines. METHODS: The randomized controlled trial was carried out in healthy Filipino adults and children. Two doses of either the current WHO prequalified OCV (Shanchol) or the same composition OCV being considered for WHO prequalification (Euvichol) were administered to participants. RESULTS: The pivotal study was conducted in total of 1263 healthy participants (777 adults and 486 children). No serious adverse reactions were elicited in either vaccine groups. Vibriocidal antibody responses to V. cholerae O1 Inaba following administration of two doses of Euvichol were non-inferior to those of Shanchol in adults (82% vs 76%) and children (87% vs 89%). Similar findings were observed for O1 Ogawa in adults (80% vs 74%) and children (91% vs 88%). CONCLUSION: A two dose schedule with Euvichol induces a strong vibriocidal response comparable to those elicited by the currently WHO prequalified OCV, Shanchol. Euvichol will be an oral cholera vaccine suitable for use in lower income countries, where cholera still has a significant economic and public health impact.
Authors: Robert K M Choy; A Louis Bourgeois; Christian F Ockenhouse; Richard I Walker; Rebecca L Sheets; Jorge Flores Journal: Clin Microbiol Rev Date: 2022-07-06 Impact factor: 50.129
Authors: Wilfredo R Matias; Brie Falkard; Richelle C Charles; Leslie M Mayo-Smith; Jessica E Teng; Peng Xu; Pavol Kováč; Edward T Ryan; Firdausi Qadri; Molly F Franke; Louise C Ivers; Jason B Harris Journal: PLoS Negl Trop Dis Date: 2016-06-16