title: Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial.
abstract: BACKGROUND
  Cholera is endemic in Bangladesh with epidemics occurring each year. The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting. We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting.
  
  
  METHODS
  We did this cluster-randomised open-label trial in Dhaka, Bangladesh. We randomly assigned 90 clusters (1:1:1) to vaccination only, vaccination and behavioural change, or no intervention. The primary outcome was overall protective effectiveness, assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose. This study is registered with ClinicalTrials.gov, number NCT01339845.
  
  
  RESULTS
  Of 268,896 people present at baseline, we analysed 267,270: 94,675 assigned to vaccination only, 92,539 assigned to vaccination and behavioural change, and 80,056 assigned to non-intervention. Vaccine coverage was 65% in the vaccination only group and 66% in the vaccination and behavioural change group. Overall protective effectiveness was 37% (95% CI lower bound 18%; p=0·002) in the vaccination group and 45% (95% CI lower bound 24%; p=0·001) in the vaccination and behavioural change group. We recorded no vaccine-related serious adverse events.
  
  
  CONCLUSIONS
  Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations.
  
  
  BACKGROUND
  Bill & Melinda Gates Foundation.
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh. Electronic address: fqadri@icddrb.org.
authors.forename: Firdausi
authors.initials: F
authors.lastname: Qadri
authors.affiliation: Johns Hopkins School of Public Health, Baltimore, MD, USA.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ali
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Fahima
authors.initials: F
authors.lastname: Chowdhury
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Ashraful Islam
authors.initials: AI
authors.lastname: Khan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Amit
authors.initials: A
authors.lastname: Saha
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Iqbal Ansary
authors.initials: IA
authors.lastname: Khan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Yasmin A
authors.initials: YA
authors.lastname: Begum
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Taufiqur R
authors.initials: TR
authors.lastname: Bhuiyan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Mohiul Islam
authors.initials: MI
authors.lastname: Chowdhury
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Md Jasim
authors.initials: MJ
authors.lastname: Uddin
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Jahangir A M
authors.initials: JAM
authors.lastname: Khan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Atique Iqbal
authors.initials: AI
authors.lastname: Chowdhury
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Anisur
authors.initials: A
authors.lastname: Rahman
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Shah Alam
authors.initials: SA
authors.lastname: Siddique
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Asaduzzaman
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Afroza
authors.initials: A
authors.lastname: Akter
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Arifuzzaman
authors.initials: A
authors.lastname: Khan
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Young
authors.initials: Y
authors.lastname: Ae You
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Ashraf Uddin
authors.initials: AU
authors.lastname: Siddik
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Nirod Chandra
authors.initials: NC
authors.lastname: Saha
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Alamgir
authors.initials: A
authors.lastname: Kabir
authors.affiliation: Government of Bangladesh, Dhaka, Bangladesh.
authors.forename: Baizid Khoorshid
authors.initials: BK
authors.lastname: Riaz
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Shwapon Kumar
authors.initials: SK
authors.lastname: Biswas
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Farzana
authors.initials: F
authors.lastname: Begum
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
authors.forename: Leanne
authors.initials: L
authors.lastname: Unicomb
authors.affiliation: Stanford University, Stanford, CA, USA.
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Luby
authors.affiliation: International Vaccine Institute, Seoul, South Korea.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Cravioto
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, CA, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Clemens
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001459:Bangladesh / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D002771:Cholera / Q000453:epidemiology* / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage*; D016000:Cluster Analysis; D019353:Endemic Diseases; D005240:Feasibility Studies; D005260:Female; D015438:Health Behavior; D006266:Health Education; D006801:Humans; D007223:Infant; D008297:Male; D016896:Treatment Outcome; D014504:Urban Health; D015164:Vaccines, Inactivated; D055815:Young Adult
chemical_list: D022121:Cholera Vaccines; D015164:Vaccines, Inactivated