Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03460002
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2016-11-21
Brief Title:
Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-CAMP
Brief Summary:
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 ie 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 21000 to 28000 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 andor 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 21000 to 28000 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None