Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau

Sanne M. Thysen, Aksel Karl Georg Jensen, Amabelia Rodrigues, Igualdino da Silva Borges, Peter Aaby, Christine Benn, Ane Fisker

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INTRODUCTION: The BCG vaccine is designed to protect against tuberculosis, but the vaccine may have broader effects. In 2014, the Strategic Advisory Group of Experts on Immunization reviewed the literature on non-specific effects of BCG, and concluded that the evidence was consistent with beneficial non-specific effects and requested further randomised trials. METHODS AND ANALYSES: Within the Bandim Health Project's urban and rural health and demographic surveillance systems, we will conduct a cluster-randomised trial in six suburban districts and 55 rural villages. Infants are enrolled at a home visit before 72 hours of life. In intervention clusters, children are vaccinated with BCG and oral polio vaccine (OPV). In control clusters, the caregivers are informed about vaccination opportunities. Using Cox-proportional hazards models, we will test whether BCG and OPV provided at a single home visit can reduce early infant mortality up to 60 days.The trial was initiated with a pilot study in Biombo region in June 2015. The trial was scaled up to full study including Oio and Cacheu regions in July 2016. The trial was expanded to include the urban study area in July 2017. ETHICS AND DISSEMINATION: BCG vaccination is delayed in many low-income settings. WHO-recommended home visits are resource demanding and vaccines are not part of the recommendation. Utilising the home visits to provide BCG and OPV may provide countries with a further incentive to introduce a single home visit. In countries, where home visits are already in place, vaccines can easily be added to reduce early infant mortality. The trial is approved by the Guinean Ethical Committee (Reference number: 0016/CNES/INASA/2015) and the Danish Ethics Committee has given its consultative approval. The results of the trial will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02504203; Pre-results.

OriginalsprogEngelsk
Artikelnummere025724
TidsskriftBMJ Open
Vol/bind9
Udgave nummer9
Antal sider7
ISSN2044-6055
DOI
StatusUdgivet - 24. sep. 2019

Fingeraftryk

Guinea-Bissau
House Calls
Mycobacterium bovis
Urban Health
Rural Health
Ethics Committees
Proportional Hazards Models
Ethics
Caregivers
Health

Citer dette

Thysen, Sanne M. ; Jensen, Aksel Karl Georg ; Rodrigues, Amabelia ; Borges, Igualdino da Silva ; Aaby, Peter ; Benn, Christine ; Fisker, Ane. / Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau. I: BMJ Open. 2019 ; Bind 9, Nr. 9.
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Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau. / Thysen, Sanne M.; Jensen, Aksel Karl Georg; Rodrigues, Amabelia; Borges, Igualdino da Silva; Aaby, Peter; Benn, Christine; Fisker, Ane.

I: BMJ Open, Bind 9, Nr. 9, e025724, 24.09.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Can earlier BCG vaccination reduce early infant mortality? Study protocol for a cluster randomised trial in Guinea-Bissau

AU - Thysen, Sanne M.

AU - Jensen, Aksel Karl Georg

AU - Rodrigues, Amabelia

AU - Borges, Igualdino da Silva

AU - Aaby, Peter

AU - Benn, Christine

AU - Fisker, Ane

PY - 2019/9/24

Y1 - 2019/9/24

N2 - INTRODUCTION: The BCG vaccine is designed to protect against tuberculosis, but the vaccine may have broader effects. In 2014, the Strategic Advisory Group of Experts on Immunization reviewed the literature on non-specific effects of BCG, and concluded that the evidence was consistent with beneficial non-specific effects and requested further randomised trials. METHODS AND ANALYSES: Within the Bandim Health Project's urban and rural health and demographic surveillance systems, we will conduct a cluster-randomised trial in six suburban districts and 55 rural villages. Infants are enrolled at a home visit before 72 hours of life. In intervention clusters, children are vaccinated with BCG and oral polio vaccine (OPV). In control clusters, the caregivers are informed about vaccination opportunities. Using Cox-proportional hazards models, we will test whether BCG and OPV provided at a single home visit can reduce early infant mortality up to 60 days.The trial was initiated with a pilot study in Biombo region in June 2015. The trial was scaled up to full study including Oio and Cacheu regions in July 2016. The trial was expanded to include the urban study area in July 2017. ETHICS AND DISSEMINATION: BCG vaccination is delayed in many low-income settings. WHO-recommended home visits are resource demanding and vaccines are not part of the recommendation. Utilising the home visits to provide BCG and OPV may provide countries with a further incentive to introduce a single home visit. In countries, where home visits are already in place, vaccines can easily be added to reduce early infant mortality. The trial is approved by the Guinean Ethical Committee (Reference number: 0016/CNES/INASA/2015) and the Danish Ethics Committee has given its consultative approval. The results of the trial will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02504203; Pre-results.

AB - INTRODUCTION: The BCG vaccine is designed to protect against tuberculosis, but the vaccine may have broader effects. In 2014, the Strategic Advisory Group of Experts on Immunization reviewed the literature on non-specific effects of BCG, and concluded that the evidence was consistent with beneficial non-specific effects and requested further randomised trials. METHODS AND ANALYSES: Within the Bandim Health Project's urban and rural health and demographic surveillance systems, we will conduct a cluster-randomised trial in six suburban districts and 55 rural villages. Infants are enrolled at a home visit before 72 hours of life. In intervention clusters, children are vaccinated with BCG and oral polio vaccine (OPV). In control clusters, the caregivers are informed about vaccination opportunities. Using Cox-proportional hazards models, we will test whether BCG and OPV provided at a single home visit can reduce early infant mortality up to 60 days.The trial was initiated with a pilot study in Biombo region in June 2015. The trial was scaled up to full study including Oio and Cacheu regions in July 2016. The trial was expanded to include the urban study area in July 2017. ETHICS AND DISSEMINATION: BCG vaccination is delayed in many low-income settings. WHO-recommended home visits are resource demanding and vaccines are not part of the recommendation. Utilising the home visits to provide BCG and OPV may provide countries with a further incentive to introduce a single home visit. In countries, where home visits are already in place, vaccines can easily be added to reduce early infant mortality. The trial is approved by the Guinean Ethical Committee (Reference number: 0016/CNES/INASA/2015) and the Danish Ethics Committee has given its consultative approval. The results of the trial will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02504203; Pre-results.

KW - BCG vaccine

KW - Cluster randomised trial

KW - Non-specific effects of vaccines

KW - Oral polio vaccine

U2 - 10.1136/bmjopen-2018-025724

DO - 10.1136/bmjopen-2018-025724

M3 - Journal article

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AN - SCOPUS:85072617184

VL - 9

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 9

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