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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 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)

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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.

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