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
, 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
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.