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

Research output: Contribution to journalArticle

24 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

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Cholera Vaccines
cholera
Philippines
mouth
vaccines
cells
Cholera
dosage
Filipinos
shanchol
Antibody Formation
World Health Organization
Appointments and Schedules
Healthy Volunteers
Vaccines
Randomized Controlled Trials
Public Health
Economics
Safety
Costs and Cost Analysis

Keywords

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

ASJC Scopus subject areas

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

Cite this

Baik, Y. O., Choi, S. K., Olveda, R. M., Espos, R. A., Ligsay, A. D., Montellano, M. B., ... 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

A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines. / Baik, Yeong Ok; Choi, Seuk Keun; Olveda, Remigio M.; Espos, Roberto A.; Ligsay, Antonio D.; Montellano, May B.; Yeam, Jong Sun; Yang, Jae Seung; Park, Ju Yeon; Kim, Deok Ryun; Desai, Sachin N.; Singh, Ajit Pal; Kim, Ick Young; Kim, Chan Wha; Park, Sue Nie.

In: Vaccine, Vol. 33, No. 46, 17.11.2015, p. 6360-6365.

Research output: Contribution to journalArticle

Baik, YO, Choi, SK, Olveda, RM, Espos, RA, Ligsay, AD, Montellano, MB, Yeam, JS, Yang, JS, Park, JY, Kim, DR, Desai, SN, Singh, AP, Kim, IY, Kim, CW & Park, SN 2015, 'A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines', Vaccine, vol. 33, no. 46, pp. 6360-6365. https://doi.org/10.1016/j.vaccine.2015.08.075
Baik, Yeong Ok ; Choi, Seuk Keun ; Olveda, Remigio M. ; Espos, Roberto A. ; Ligsay, Antonio D. ; Montellano, May B. ; Yeam, Jong Sun ; Yang, Jae Seung ; Park, Ju Yeon ; Kim, Deok Ryun ; Desai, Sachin N. ; Singh, Ajit Pal ; Kim, Ick Young ; Kim, Chan Wha ; Park, Sue Nie. / A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines. In: Vaccine. 2015 ; Vol. 33, No. 46. pp. 6360-6365.
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AU - Choi, Seuk Keun

AU - Olveda, Remigio M.

AU - Espos, Roberto A.

AU - Ligsay, Antonio D.

AU - Montellano, May B.

AU - Yeam, Jong Sun

AU - Yang, Jae Seung

AU - Park, Ju Yeon

AU - Kim, Deok Ryun

AU - Desai, Sachin N.

AU - Singh, Ajit Pal

AU - Kim, Ick Young

AU - Kim, Chan Wha

AU - Park, Sue Nie

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N2 - 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.

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KW - Adults

KW - Children

KW - Euvichol

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KW - Oral cholera vaccine

KW - Safety

KW - Shanchol

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