Tools for Practice


#108 Tools for Stools: Oral Cholera Vaccine for Travelers’ Diarrhea Prophylaxis


CLINICAL QUESTION
Should oral cholera vaccine (DukoralTM) be routinely recommended to prevent travelers’ diarrhea (TD)?


BOTTOM LINE
Randomized Controlled Trials (RCT) evaluating Dukoral™ for TD did not show a benefit and routine use is not recommended.



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EVIDENCE
Systematic review of 24 RCTs of vaccines to prevent TD.1 Many tested vaccines in cholera endemic areas (not travelers) and examined immunologic (not clinical) outcomes.
  • RCT of 502 US college students, given oral cholera vaccine or placebo upon arrival in Mexico, with a second dose ten days later found no difference in:2
    • Diarrhea (any cause): vaccine 51%, placebo 49%.
    • Enterotoxigenic E. coli (ETEC) diarrhea: vaccine 14%, placebo 15%.
    • Diarrhea was reduced ≥7 days after second dose, but this was not confirmed by external re-analysis.1
    • Adverse events: not reported.
  • RCT of 187 travelers comparing ETEC vaccine, oral cholera vaccine, and placebo (given at least seven days before leaving) found:3
    • No significant difference between groups in all-cause diarrhea.
      • Placebo 21%, ETEC vaccine 24%, oral cholera vaccine 27%.
Context:
  • Diarrhea, usually from ETEC, affects up to 50% of travelers to developing countries.4-6
  • Risk of cholera is ~1/10,000 to 1/million per month abroad.7
  • Cholera toxin subunit in vaccine triggers cross-immunity to ETEC8 leading to its indication for prevention of TD.9
  • Most cases of TD resolve spontaneously in 3–4 days,5 but taking antibiotics at onset improves 72 hour cure (84% vs. 50%, Number Needed to Treat 3).10
  • North American guidelines do not recommend oral cholera vaccine for majority of travelers.4,5
  • Vaccine costs ~$90; not covered by any provincial health care plans.


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Author(s):

  • Michael R Kolber BSc MD CCFP MSc
  • Tony Nickonchuk BScPharm

1. Ahmed T, Bhuiyan TR, Zaman K, et al. Cochrane Database Syst Rev. 2013; 7:CD009029.

2. Scerpella EG, Sanchez JL, Mathewson JJ, et al. J Travel Med. 1995; 2:22-7.

3. Wiedermann G, Kollaritsch H, Kundi M, et al. J Travel Med. 2000; 7:27-9.

4. Canada Communicable Disease Report. 2005; 31. http://www.phacaspc.gc.ca/publicat/ccdr-rmtc/05vol31/asc-dcc-7/index-eng.php. Last accessed November 8, 2013.

5. Hill DR, Ericsson CD, Pearson RD, et al. Clin Infect Dis. 2006; 43:1499-539.

6. Adachi JA, Xiang Z, Mathewson JJ, et al. Clin Infect Dis. 2001; 32:1706-9.

7. Steffen R, Acar J, Walker E, Zuckerman J. Travel Med Infect Dis. 2003; 1:80-8.

8. Hill DR, Ford L, Lalloo DG. Lancet Infect Dis. 2006; 6: 361-73.

9. Dukoral Product Monograph 2012; pg 5. http://www.janssen.ca/subcategory_docdownload?id=1586. Last accessed December 8, 2013.

10. de Bruyn G, Hahn S, Borwick A. Cochrane Database Syst Rev. 2009; 1:CD002242.

Authors do not have any conflicts of interest to declare.