There is increasing interest to use oral cholera vaccination as an additional strategy to water and sanitation interventions against endemic and epidemic cholera. There are two internationally-available and WHO-prequalified oral cholera vaccines: an inactivated vaccine containing killed whole-cells of V. cholerae O1 with recombinant cholera toxin B-subunit (WC/rBS) and a bivalent inactivated vaccine containing killed whole cells of V. cholerae O1 and V. cholerae O139 (BivWC). The efficacy, effectiveness, direct and indirect (herd) protection conferred by WC/rBS and BivWC are well established. Yet governments may need local evidence of vaccine impact to justify and scale-up mass oral cholera vaccination campaigns. We discuss various approaches to assess oral cholera vaccine protection, which may be useful to policymakers and public health workers considering deployment and evaluation of the vaccine.
References
[1]
World Health Organization (2009) Meeting of the Strategic Advisory Group of Experts on immunization, October 2009– conclusions and recommendations. Weekly epidemiological record 50: 526–528. doi: 10.1016/j.biologicals.2009.12.007
[2]
Martin S, Costa A, Perea W (2012) Editorial: Stockpiling oral cholera vaccine. Bull World Health Organ 90: 714. doi: 10.2471/blt.12.112433
Clemens JD, Sack DA, Harris JR, Van Loon F, Chakraborty J, et al. (1990) Field trial of oral cholera vaccines in Bangladesh: results from three-year follow-up. Lancet 335: 270–3. doi: 10.1016/0140-6736(90)90080-o
[5]
Sanchez J L, Vasquez B, Beque R, Meza R, Castellares G, et al. (1994) Protective efficacy of the oral whole cell/recombinant B subunit cholera vaccine in Peruvian military recruits. Lancet 344: 1273–6. doi: 10.1016/s0140-6736(94)90755-2
[6]
Lucas ME, Deen JL, von Seidlein L, Wang XY, Ampuero J, et al. (2005) Effectiveness of a mass oral cholera vaccination in Beira, Mozambique. New England Journal of Medicine 352: 757–67. doi: 10.1056/nejmoa043323
[7]
Khatib AM, Ali M, von Seidlein L, Kim DR, Hashim R, et al. Effectiveness of an oral cholera vaccine in Zanzibar: findings from a mass vaccination campaign and observational cohort study. Lancet Infectious Disease. 12: 837–44. doi: 10.1016/s1473-3099(12)70196-2
[8]
Ali M, Emch M, von Seidlein L, Yunus M, Sack DA, et al. (2005) Herd immunity conferred by killed oral cholera vaccines in Bangladesh: a reanalysis. Lancet 366: 44–9. doi: 10.1016/s0140-6736(05)66550-6
[9]
Martin S, Lopez AL, Bellos A, Deen J, Ali M, et al.. (2013) Post-licensure deployment of currently available oral cholera vaccines: A systematic review. Submitted for publication.
[10]
Peltola H, Siitonen A, Kyr？nsepp？ H, Simula I, Mattila L, et al. (1991) Prevention of travellers’ diarrhea by oral B-subunit/whole-cell cholera vaccine. Lancet 338: 1285–9. doi: 10.1016/0140-6736(91)92590-x
[11]
Clemens JD, Sack DA, Harris JR, Chakraborty J, Neogy PK, et al. (1988) Cross protection by B subunit whole cell cholera vaccine against diarrhea associated with heat-labile toxin producing enterotoxigenic Escherichia coli: Results of a large scale field trial. J Inf Dis 158: 372–7. doi: 10.1093/infdis/158.2.372
[12]
Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, et al. (2009) Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet 374: 1694–702. doi: 10.1016/s0140-6736(09)61297-6
[13]
Sur D, Kanungo S, Sah B, Manna B, Ali M, et al. (2011) Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial. PLoS Negl Trop Dis 5: e1289. doi: 10.1371/journal.pntd.0001289
[14]
Bhattacharya S, Sur D, Ali M, Kanungo S, You YA, et al.. (2013) 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis 2013; published online Oct 18.
[15]
Ali M, Sur D, You YA, Kanungo S, Sah B, et al. (2013) Herd Protection by a Bivalent Killed Whole-Cell Oral Cholera Vaccine in the Slums of Kolkata, India. CID 56: 1123–31. doi: 10.1093/cid/cit009
[16]
Clemens J, Brenner R, Rao M, Tafari N, Lowe C (1996) Evaluating new vaccines for developing countries. Efficacy or effectiveness? JAMA 275: 390–7. doi: 10.1001/jama.1996.03530290060038
[17]
Jeuland M, Cook J, Poulos C, Clemens J, Whittington D, et al. (2009) Cost-effectiveness of new-generation oral cholera vaccines: a multisite analysis. Value Health 12: 899–908. doi: 10.1111/j.1524-4733.2009.00562.x
[18]
World Health Organization (2010) Oral cholera vaccines in mass immunization campaigns: guidance for planning and use. WHO press, Geneva.
[19]
Orenstein WA, Bernier RH, Dondero T, Hinman AR, Marks JS, et al. (1985) Field evaluation of vaccine efficacy. Bull World Health Organ 63: 1055–68.
[20]
Torvaldsen S, McIntyre PB (2002) Observational methods in epidemiologic assessment of vaccine effectiveness. Commun Dis Intell 26: 451–7.
[21]
Farrington CP (1993) Estimation of vaccine effectiveness using the screening method. International J Epid 22: 742–6. doi: 10.1093/ije/22.4.742
[22]
Schlesselman JJ (1982) Case-control studies: Design, conduct, analysis. New York: Oxford University Press.
[23]
Gessner BD, Brooks WA, Neuzil KM, Vernet G, Bright RA, et al. (2013) Vaccines as a tool to estimate the burden of severe influenza in children of low-resourced areas (November 30– December 1, 2012, Les Pensieres, Veyrier-du-Lac, France). Vaccine 31: 3222–8. doi: 10.1016/j.vaccine.2013.05.017
[24]
Donner A, Klar N (2010) Design and analysis of cluster randomization trials in health research. London: Arnold Publishers Limited.
[25]
McPherson M, Smith-Lovin L, Cook J (2001) Birds of a feather: Homophily in social networks. Annual Review of Sociology 27: 415–44. doi: 10.1146/annurev.soc.27.1.415
[26]
Meyers L, Newman M, Martin M, Schrag S (2003) Applying network theory to epidemics: Control measures for Mycoplasma pneumoniae outbreaks. Emerging Infectious Diseases 9: 204–10. doi: 10.3201/eid0902.020188
[27]
Meyers L (2007) Contact network epidemiology: Bond percolation applied to infectious disease prediction and control. Bulletin of the American Mathematical Society 44: 63–86. doi: 10.1090/s0273-0979-06-01148-7
[28]
Morris M (2005) Network Epidemiology: A Handbook for Survey Design and Data Collection. Oxford: Oxford University Press.
[29]
Ali M, Park JK, Thiem VD, Canh DG, Emch M, Clemens JD (2005) Neighborhood size and local geographic variation of health and social determinants. Int J Health Geographics 4: 12. doi: 10.1186/1476-072x-4-12
[30]
Oliver MA, Webster R Kriging (1990) A Method of Interpolation for Geographical Information Systems. Int J Geogr Inf Syst 4: 313–32. doi: 10.1080/02693799008941549
[31]
Abdi H (2007) Bonferroni and ？idák corrections for multiple comparisons. In Salkind, N. J. Encyclopedia of Measurement and Statistics. Thousand Oaks, CA: Sage.
[32]
Adegbola RA, Secka O, Lahai G, Lloyd-Evans N, Njie A, et al. (2005) Elimination of Haemophilus influenzae type b (Hib) disease from The Gambia after the introduction of routine immunisation with a Hib conjugate vaccine: a prospective study. Lancet 366: 144–50. doi: 10.1016/s0140-6736(05)66788-8
[33]
Howie SR, Antonio M, Akisanya A, Sambou S, Hakeem I, et al. (2007) Re-emergence of Haemophilus influenzae type b (Hib) disease in The Gambia following successful elimination with conjugate Hib vaccine. Vaccine 25: 6305–9. doi: 10.1016/j.vaccine.2007.06.023
[34]
Emch M, Yunus M, Escamilla V (2010) Local population and regional environmental drivers of cholera in Bangladesh. Environ Health 9: 2. doi: 10.1186/1476-069x-9-2
[35]
Belmaker I, Dukhan L, Yosef Y, Leventhal A, Dagan R (2007) Elimination of hepatitis a infection outbreaks in day care and school settings in southern Israel after introduction of the national universal toddler hepatitis a immunization program. Pediatr Infect Dis J 26: 36–40. doi: 10.1097/01.inf.0000247105.45185.13
[36]
Longini IM Jr, Nizam A, Ali M, Yunus M, Shenvi N, Clemens JD (2007) Controlling endemic cholera with oral vaccines. PLoS Med 4: e336. doi: 10.1371/journal.pmed.0040336
[37]
Chao DL, Halloran ME, Longini IM Jr (2011) Vaccination strategies for epidemic cholera in Haiti with implications for the developing world. Proc Natl Acad Sci U S A 108: 7081–5. doi: 10.1073/pnas.1102149108
[38]
Chao DL, Longini IM Jr, Morris JG Jr (2013) Modeling cholera outbreaks. Curr Top Microbiol Immunol. Epub ahead of print.
[39]
World Health Organization (2008) Generic protocol for monitoring impact of rotavirus vaccination on gastroenteritis disease burden and viral strains. WHO press, Geneva.
[40]
World Health Organization (2012) Measuring impact of Streptococcus pneumoniae and Haemophilus influenzae type b conjugate vaccination. WHO press, Geneva.
