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Volume 17, Number 11—November 2011
THEME ISSUE
CHOLERA IN HAITI
Synopsis

Considerations for Oral Cholera Vaccine Use during Outbreak after Earthquake in Haiti, 2010−2011

Kashmira A. DateComments to Author , Andrea Vicari, Terri B. Hyde, Eric D. Mintz, M. Carolina Danovaro-Holliday, Ariel Henry, Jordan W. Tappero, Thierry H. Roels, Joseph Abrams, Brenton T. Burkholder, Cuauhtémoc Ruiz-Matus, Jon Andrus, and Vance Dietz
Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (K.A. Date, T.B. Hyde, E. Mintz, A. Henry, J.W. Tappero, T.H. Roels, J. Abrams, B.T. Burkholder, V. Dietz); Pan American Health Organization, Washington DC, USA (A. Vicari, M.C. Danovaro-Holliday, C. Ruiz-Matus, J. Andrus); Ministère de la Santé Publique et de la Population, Port-Au-Prince, Haiti (A. Henry)

Main Article

Table 1

Salient features of oral cholera vaccines available as of December 31, 2010*

Feature Dukoral† Shanchol
Composition Monovalent formalin-based heat-killed whole cells of Vibrio cholerae O1 (classical and El Tor, Inaba and Ogawa) + recombinant cholera toxin B subunit Bivalent, killed whole cells of V. cholerae O1 (Inaba and Ogawa, classical and El Tor) and O139
Number of doses for full immunization 2 doses (3 doses in children 2–5 y) 2 doses
Schedule 7–14 d apart (up to 42 d apart) 14 d apart
Age for vaccination per licensure >2 y >1 y
Administration Oral with buffer Oral
Requirement for buffer and water Yes (adults,150 mL; children 2–5 y, 75 mL) No (water may be used)
Food and water restrictions before and after vaccination No food or water 1 h before and after ingestion of vaccine None
Packaging 3-mL single dose vials (vaccine) + effervescent granules in a sachet (buffer) 1.5-mL single dose vial
Cold-chain and other storage requirements 2–8°C; additional storage space for water (not in cold chain) 2–8°C
Shelf life 3 y at 2–8°C; stable for 1 mo at 37°C 2 y at 2–8°C
WHO prequalified Yes No
Cost of vaccine US $6 per dose ($12–$18 for full series, i.e., for 2–3 doses); price quoted for Haiti in January 2011, $3.64 per dose $1.85 per dose ($3.70 for full series)
Safety profile High High
Earliest onset of protection 7–10 d after full immunization 7–10 d after full immunization per manufacturer
Efficacy and effectiveness Matlab trial, Bangladesh: 85% at 4–6 mo; 62% at 1 y, 58% at 2 y, 18% at 3 y; in 2–5 y olds: 100% at 4–6 mo, 38% at 1 y; military center, Peru: 86% at 4–5 mo; outskirts of Lima, Peru: 60% at 2 y; Beira, Mozambique: 85% with 2 doses, 78% with >1 dose at 1–6 mo Kolkata, India: 67% at 2-y follow-up with 2 doses
Single dose effectiveness Low; Matlab trial, Bangladesh: 12% during 3 y (lower limit of 95% confidence interval –29%) Unknown
studies planned
Herd protection Yes Expected but not yet demonstrated

*Other oral cholera vaccines not summarized: An injectable vaccine may be available in some countries, but is not recommended by the World Health Organization (WHO) because of its reactogenicity, limited efficacy, and short duration of protection; mORCVAX, similar to Shanchol, is licensed in Vietnam but is not eligible for WHO prequalification, which restricts its global utilization; a single-dose, oral, live attenuated cholera vaccine (CVD 103-HgR: Orochol, Mutachol) by Crucell/Berna Biotech is no longer manufactured. Several new oral cholera vaccines, intended to be administered as a single dose, are in different stages of development and licensure. However, these vaccines in the most advanced stages of development, including Peru-15 (USA and China), V. cholerae 638 (Cuba), and VA1.4 (India), are at least a few years away from becoming widely available.
†Includes data from early vaccine trials of whole-cell recombinant beta subunit and whole-cell beta subunit vaccine for Dukoral.

Main Article

Page created: October 27, 2011
Page updated: October 27, 2011
Page reviewed: October 27, 2011
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
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