Bivalent oral cholera vaccine in participants aged 1 year and older in the Dominican Republic: A phase III, single-arm, safety and immunogenicity trial

References

• Ali M, Nelson AR, Lopez AL, Sack DA. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015;9:e0003832. doi:10.1371/journal.pntd.0003832.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Use of Oral Cholera Vaccine in Humanitarian Emergencies. 2014. http://www.who.int/cholera/vaccines/OCV_in_humanitarian_emergencies_15Jan2014.pdf
   Google Scholar
• Kanungo S, Desai SN, Saha J, Nandy RK, Sinha A, Kim DR, Bannerjee B, Manna B, Yang JS, Ali M, et al. An Open Label Non-inferiority Trial Assessing Vibriocidal Response of a Killed Bivalent Oral Cholera Vaccine Regimen following a Five Year Interval in Kolkata, India. PLoS Negl Trop Dis. 2015;9:e0003809. doi:10.1371/journal.pntd.0003809.
   PubMed Web of Science ®Google Scholar
• Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Asaduzzaman M, Akter A, Khan A, et al. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016;374:1723–32. doi:10.1056/NEJMoa1510330.
   PubMed Web of Science ®Google Scholar
• Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, et al. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2013;13:1050–6. doi:10.1016/S1473-3099(13)70273-1.
   PubMed Web of Science ®Google Scholar
• Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, Yang JS, Hussein J, Park JY, Jang MS, et al. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015;93:527–33. doi:10.4269/ajtmh.14-0683.
   PubMed Web of Science ®Google Scholar
• Charles RC, Hilaire IJ, Mayo-Smith LM, Teng JE, Jerome JG, Franke MF, Saha A, Yu Y, Kováč P, Calderwood SB, et al. Immunogenicity of a killed bivalent (O1 and O139) whole cell oral cholera vaccine, Shanchol, in Haiti. PLoS Negl Trop Dis. 2014;8:e2828. doi:10.1371/journal.pntd.0002828.
   PubMed Web of Science ®Google Scholar
• Severe K, Rouzier V, Anglade SB, Bertil C, Joseph P, Deroncelay A, Mabou MM, Wright PF, Guillaume FD, Pape JW, et al. Effectiveness of Oral Cholera Vaccine in Haiti: 37-Month Follow-Up. Am J Trop Med Hyg. 2016;94:1136–42. doi:10.4269/ajtmh.15-0700.
   PubMed Web of Science ®Google Scholar
• Pan American Health Organization. Epidemiological update: cholera. 2015. http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=31604&Itemid=270&lang=en
   Google Scholar
• Saha A, Chowdhury MI, Khanam F, Bhuiyan MS, Chowdhury F, Khan AI, Khan IA, Clemens J, Ali M, Cravioto A, et al. Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. Vaccine. 2011;29:8285–92. doi:10.1016/j.vaccine.2011.08.108.
   PubMed Web of Science ®Google Scholar
• Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, et al. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015;9:e0003574. doi:10.1371/journal.pntd.0003574.
   PubMed Web of Science ®Google Scholar
• Iyer AS, Bouhenia M, Rumunu J, Abubakar A, Gruninger RJ, Pita J, Lino RL, Deng LL, Wamala JF, Ryan ET, et al. Immune Responses to an Oral Cholera Vaccine in Internally Displaced Persons in South Sudan. Sci Rep. 2016;6:35742. doi:10.1038/srep35742.
   PubMed Web of Science ®Google Scholar
• Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, et al. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009;27:6887–93. doi:10.1016/j.vaccine.2009.09.008.
   PubMed Web of Science ®Google Scholar
• Baik YO, Choi SK, Olveda RM, Espos RA, Ligsay AD, Montellano MB, Yeam JS, Yang JS, Park JY, Kim DR, et al. A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines. Vaccine. 2015;33:6360–5. doi:10.1016/j.vaccine.2015.08.075.
   PubMed Web of Science ®Google Scholar
• Concha A, Giraldo A, Castaneda E, Martinez M, de la Hoz F, Rivas F, Depetris A, Svennerholm AM, Sack DA. Safety and immunogenicity of oral killed whole cell recombinant B subunit cholera vaccine in Barranquilla, Colombia. Bull Pan Am Health Organ. 1995;29:312–21.
   PubMedGoogle Scholar
• Anh DD, Canh DG, Lopez AL, Thiem VD, Long PT, Son NH, Deen J, von Seidlein L, Carbis R, Han SH, et al. Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine. 2007;25:1149–55. doi:10.1016/j.vaccine.2006.09.049.
   PubMed Web of Science ®Google Scholar
• Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, et al. A Randomized, Placebo-Controlled Trial of the Bivalent Killed, Whole-Cell, Oral Cholera Vaccine in Adults and Children in a Cholera Endemic Area in Kolkata, India. PLoS One. 2008;3:e2323. doi:10.1371/journal.pone.0002323.
   PubMed Web of Science ®Google Scholar
• World Health Organization. The Immunological Basis for Immunization Series, Module 14: Cholera. http://apps.who.int/iris/bitstream/10665/44367/1/9789241599740_eng.pdf
   Google Scholar
• World Health Organization. Guidelines for the Production and Control of Inactivated Oral Cholera Vaccines. WHO Technical Report Series. 2004;130–149, No 924, Annex 3. http://www.who.int/biologicals/publications/trs/areas/vaccines/cholera/129-149.pdf?ua=1
   Google Scholar
• Kossaczka Z, Shiloach J, Johnson V, Taylor DN, Finkelstein RA, Robbins JB, Szu SC. Vibrio cholerae O139 conjugate vaccines: synthesis and immunogenicity of V. cholerae O139 capsular polysaccharide conjugates with recombinant diphtheria toxin mutant in mice. Infect Immun. 2000; 68:5037–43. doi:10.1128/IAI.68.9.5037-5043.2000.
   PubMed Web of Science ®Google Scholar
• Losonsky GA, Lim Y, Motamedi P, Comstock LE, Johnson JA, Morris JG, Jr., Tacket CO, Kaper JB, Levine MM. Vibriocidal antibody responses in North American volunteers exposed to wild-type or vaccine Vibrio cholerae O139: specificity and relevance to immunity. Clin Diagn Lab Immunol. 1997;4:264–9.
   PubMedGoogle Scholar
• Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72. doi:10.1002/(SICI)1097-0258(19980430)17:8%3c857::AID-SIM777%3e3.0.CO;2-E.
   PubMed Web of Science ®Google Scholar