Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
NCT ID: NCT03460002
Last Updated: 2024-09-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
28612 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-11-30
Study Completion Date
2022-08-31
Brief Summary
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The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Studies from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child morbidity and mortality unrelated to prevention of the targeted diseases.
The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions.
The hypotheses are:
RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection.
RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection.
Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000).
To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group:
A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.
The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions.
The hypotheses are:
RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection.
RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection.
Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000).
To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group:
A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.
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Detailed Description
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Conditions
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Measles Vaccination
Oral Polio Vaccine
Non-specific/Heterologous Effects of Vaccines
Mortality
Morbidity
Children
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The RECAMP trials test two separate hypotheses relating to the potential beneficial non-specific effects of providing live vaccines in general vaccination campaigns.
The RECAMP-MV trial tests the effect of a Measles Vaccination campaign among children aged 9-59 months The RECAMP-OPV trial tests the effect of an Oral Polio Vaccination campaign in children aged 0-8 months
The RECAMP-MV trial tests the effect of a Measles Vaccination campaign among children aged 9-59 months The RECAMP-OPV trial tests the effect of an Oral Polio Vaccination campaign in children aged 0-8 months
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Caregivers
Study Groups
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Measles vaccine
In intervention villages children will be weighed and receive standard measles vaccine in one dose if they are between 9-59 months old.
Group Type
EXPERIMENTAL
Measles vaccine
Intervention Type
BIOLOGICAL
A measles vaccine prequalified from the World Health Organization will be administered in one dose by deep subcutaneous injection into the left subscapular region by a local nurse.
Oral polio vaccine
In intervention villages children will be weighed and receive standard oral polio vaccine in one or two doses if they are between 0-8 months old.
Group Type
EXPERIMENTAL
Oral polio vaccine
Intervention Type
BIOLOGICAL
A bivalent oral polio vaccine prequalified by the World Health Organization will be administered in one or two doses directly into the mouth of the vaccinee with two drops per dose by a local nurse.
Weighing-MV
In control villages children aged 9-59 months acting as controls to the MV-intervention arm will be weighed only.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Weighing-OPV
In control villages children aged 0-8 months acting as controls to the OPV-intervention arm will be weighed only.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Measles vaccine
A measles vaccine prequalified from the World Health Organization will be administered in one dose by deep subcutaneous injection into the left subscapular region by a local nurse.
Intervention Type
BIOLOGICAL
Oral polio vaccine
A bivalent oral polio vaccine prequalified by the World Health Organization will be administered in one or two doses directly into the mouth of the vaccinee with two drops per dose by a local nurse.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Exclusion Criteria
* the child has temperature \> 39.0◦C or a severe acute illness as defined by the examining nurse
OR
* the child has as a mid upper arm circumference \< 110 mm and is older than 6 months (most feasible local indicator of AIDS and chronic immunosuppressive disease)
OR
* the child has experienced a severe allergic reaction after previous vaccination, drug or food.
OR
* the child is enrolled in an ongoing study of Bacillus Calmette Guerin vaccine and is \< 2 months old
OR
* For the RECAMP-MV trial: the child is enrolled in RECAMP-OPV
OR
* the child has as a mid upper arm circumference \< 110 mm and is older than 6 months (most feasible local indicator of AIDS and chronic immunosuppressive disease)
OR
* the child has experienced a severe allergic reaction after previous vaccination, drug or food.
OR
* the child is enrolled in an ongoing study of Bacillus Calmette Guerin vaccine and is \< 2 months old
OR
* For the RECAMP-MV trial: the child is enrolled in RECAMP-OPV
Minimum Eligible Age
0 Months
Maximum Eligible Age
59 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Statens Serum Institut
OTHER
Sponsor Role
collaborator
Research Center for Vitamins and Vaccines
UNKNOWN
Sponsor Role
collaborator
Bandim Health Project
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ane Fisker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Peter Aaby, DMSc,Professor
Role: PRINCIPAL_INVESTIGATOR
Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Aksel Jensen, PhD
Role: PRINCIPAL_INVESTIGATOR
Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Anshu Varma, MSc
Role: PRINCIPAL_INVESTIGATOR
Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Amabelia Rodrigues, Ph
Role: PRINCIPAL_INVESTIGATOR
Bandim Health Project, Guinea-Bissau
Locations
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Bandim Health Project
Bissau, , Guinea-Bissau
Site Status
Countries
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Guinea-Bissau
References
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World Health Organization. Global measles and rubella strategic plan: 2012-2020. 2012.
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World Health Organization. Polio eradication and endgame strategic plan: 2013-2018. 2013.
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Meeting of the Strategic Advisory Group of Experts on immunization, October 2015 - conclusions and recommendations. Wkly Epidemiol Rec. 2015 Dec 11;90(50):681-99. No abstract available. English, French.
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Benn CS, Rodrigues A, Yazdanbakhsh M, Fisker AB, Ravn H, Whittle H, Aaby P. The effect of high-dose vitamin A supplementation administered with BCG vaccine at birth may be modified by subsequent DTP vaccination. Vaccine. 2009 May 11;27(21):2891-8. doi: 10.1016/j.vaccine.2009.02.080. Epub 2009 Mar 9.
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BACKGROUND
Meeting of the Strategic Advisory Group of Experts on immunization, April 2014 -- conclusions and recommendations. Wkly Epidemiol Rec. 2014 May 23;89(21):221-36. No abstract available. English, French.
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BACKGROUND
Aaby P, Gustafson P, Roth A, Rodrigues A, Fernandes M, Sodemann M, Holmgren B, Benn CS, Garly ML, Lisse IM, Jensen H. Vaccinia scars associated with better survival for adults. An observational study from Guinea-Bissau. Vaccine. 2006 Jul 17;24(29-30):5718-25. doi: 10.1016/j.vaccine.2006.04.045. Epub 2006 May 6.
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BACKGROUND
Jensen ML, Dave S, Schim van der Loeff M, da Costa C, Vincent T, Leligdowicz A, Benn CS, Roth A, Ravn H, Lisse IM, Whittle H, Aaby P. Vaccinia scars associated with improved survival among adults in rural Guinea-Bissau. PLoS One. 2006 Dec 20;1(1):e101. doi: 10.1371/journal.pone.0000101.
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BACKGROUND
Rieckmann A, Villumsen M, Sorup S, Haugaard LK, Ravn H, Roth A, Baker JL, Benn CS, Aaby P. Vaccinations against smallpox and tuberculosis are associated with better long-term survival: a Danish case-cohort study 1971-2010. Int J Epidemiol. 2017 Apr 1;46(2):695-705. doi: 10.1093/ije/dyw120.
Reference Type
BACKGROUND
Varma A, Aaby P, Thysen SM, Jensen AKG, Fisker AB. Reduction in Short-term Outpatient Consultations After a Campaign With Measles Vaccine in Children Aged 9-59 Months: Substudy Within a Cluster-Randomized Trial. J Pediatric Infect Dis Soc. 2020 Nov 10;9(5):535-543. doi: 10.1093/jpids/piaa091.
Reference Type
DERIVED
Varma A, Jensen AKG, Thysen SM, Pedersen LM, Aaby P, Fisker AB. Research protocol of two concurrent cluster-randomized trials: Real-life Effect of a CAMPaign with Measles Vaccination (RECAMP-MV) and Real-life Effect of a CAMPaign with Oral Polio Vaccination (RECAMP-OPV) on mortality and morbidity among children in rural Guinea-Bissau. BMC Public Health. 2019 Nov 11;19(1):1506. doi: 10.1186/s12889-019-7813-y.
Reference Type
DERIVED
Other Identifiers
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RE-CAMP
Identifier Type: -
Identifier Source: org_study_id
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