A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines

Yeong Ok Baik, Seuk Keun Choi, Remigio M. Olveda, Roberto A. Espos, Antonio D. Ligsay, May B. Montellano, Jong Sun Yeam, Jae Seung Yang, Ju Yeon Park, Deok Ryun Kim, Sachin N. Desai, Ajit Pal Singh, Ick Young Kim, Chan Wha Kim, Sue Nie Park

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26 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)6360-6365
Number of pages6
JournalVaccine
Volume33
Issue number46
DOIs
Publication statusPublished - 2015 Nov 17

Keywords

  • Adults
  • Children
  • Euvichol
  • Immunogenicity
  • Oral cholera vaccine
  • Safety
  • Shanchol

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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  • Cite this

    Baik, Y. O., Choi, S. K., Olveda, R. M., Espos, R. A., Ligsay, A. D., Montellano, M. B., Yeam, J. S., Yang, J. S., Park, J. Y., Kim, D. R., Desai, S. N., Singh, A. P., Kim, I. Y., Kim, C. W., & Park, S. N. (2015). A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines. Vaccine, 33(46), 6360-6365. https://doi.org/10.1016/j.vaccine.2015.08.075