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Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial.
Qadri, Firdausi; Ali, Mohammad; Chowdhury, Fahima; Khan, Ashraful Islam; Saha, Amit; Khan, Iqbal Ansary; Begum, Yasmin A; Bhuiyan, Taufiqur R; Chowdhury, Mohiul Islam; Uddin, Md Jasim; Khan, Jahangir A M; Chowdhury, Atique Iqbal; Rahman, Anisur; Siddique, Shah Alam; Asaduzzaman, Muhammad; Akter, Afroza; Khan, Arifuzzaman; Ae You, Young; Siddik, Ashraf Uddin; Saha, Nirod Chandra; Kabir, Alamgir; Riaz, Baizid Khoorshid; Biswas, Shwapon Kumar; Begum, Farzana; Unicomb, Leanne; Luby, Stephen P; Cravioto, Alejandro; Clemens, John D.
Afiliação
  • Qadri F; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh. Electronic address: fqadri@icddrb.org.
  • Ali M; Johns Hopkins School of Public Health, Baltimore, MD, USA.
  • Chowdhury F; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Khan AI; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Saha A; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Khan IA; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Begum YA; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Bhuiyan TR; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Chowdhury MI; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Uddin MJ; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Khan JAM; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Chowdhury AI; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Rahman A; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Siddique SA; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Asaduzzaman M; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Akter A; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Khan A; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Ae You Y; International Vaccine Institute, Seoul, South Korea.
  • Siddik AU; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Saha NC; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Kabir A; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Riaz BK; Government of Bangladesh, Dhaka, Bangladesh.
  • Biswas SK; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Begum F; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Unicomb L; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  • Luby SP; Stanford University, Stanford, CA, USA.
  • Cravioto A; International Vaccine Institute, Seoul, South Korea.
  • Clemens JD; International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, CA, USA.
Lancet ; 386(10001): 1362-1371, 2015 Oct 03.
Article em En | MEDLINE | ID: mdl-26164097
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 (111) 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.

FINDINGS:

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.

INTERPRETATION:

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.

FUNDING:

Bill & Melinda Gates Foundation.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vacinas contra Cólera / Cólera / Saúde da População Urbana / Doenças Endêmicas Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male País/Região como assunto: Asia Idioma: En Revista: Lancet Ano de publicação: 2015 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vacinas contra Cólera / Cólera / Saúde da População Urbana / Doenças Endêmicas Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Infant / Male País/Região como assunto: Asia Idioma: En Revista: Lancet Ano de publicação: 2015 Tipo de documento: Article