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Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children (RE-CAMP)

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ClinicalTrials.gov Identifier: NCT03460002
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : March 2, 2021
Sponsor:
Collaborators:
Statens Serum Institut
Research Center for Vitamins and Vaccines
Information provided by (Responsible Party):
Bandim Health Project

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date March 2, 2021
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2018)
Composite outcome: mortality and hospital admission (measured as a rate) [ Time Frame: Enrolment to end of study (longest follow-up 2 years) ]
Death (registered through follow-up visits, verified by verbal autopsies) or first admission (overnight stay at hospital registered by interview at follow up visits)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2018)
  • Mortality [ Time Frame: Enrolment to end of study (longest follow-up 2 years) ]
    Death (registered through follow-up visits, verified by verbal autopsies)
  • Hospital admission [ Time Frame: Enrolment to end of study (longest follow-up 2 years) ]
    admission (overnight stay at hospital registered by interview at follow up visits)
  • Nutritional status [ Time Frame: Enrolment to end of study (longest follow-up 2 years) ]
    Mid-upper-arm-circumference registered with measurement tape as per UNICEF recommendations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2018)
  • Acute adverse reactions [ Time Frame: One-two months after a child is included in the study ]
    Health center consultations and illness registered through follow-up visits
  • Changes to the Respiratory and Gut Microbiome [ Time Frame: Two months after a child is included in the study ]
    Among 100 children enrolled in the OPV or corresponding control arm (Weighing-OPV), a nasal swab and a rectal swab will be collected at enrolment and 2 months later to assess effects of campaign OPV on the microbiome.
Original Other Pre-specified Outcome Measures
 (submitted: March 4, 2018)
Acute adverse reactions [ Time Frame: One month after a child is included in the study ]
Health center consultations registered through follow-up visits
 
Descriptive Information
Brief Title  ICMJE Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children
Official Title  ICMJE A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children
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, 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Measles Vaccination
  • Oral Polio Vaccine
  • Non-specific/Heterologous Effects of Vaccines
  • Mortality
  • Morbidity
  • Children
Intervention  ICMJE
  • Biological: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Biological: Measles vaccine
  • Experimental: 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.
    Intervention: Biological: Oral polio vaccine
  • No Intervention: Weighing-MV
    In control villages children aged 9-59 months acting as controls to the MV-intervention arm will be weighed only.
  • No Intervention: Weighing-OPV
    In control villages children aged 0-8 months acting as controls to the OPV-intervention arm will be weighed only.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
28000
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2018)
21000
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Children aged 0-59 months living with families registered in the rural Bandim Health Project Health and Demographic Surveillance Site are included, provided a parent/guardian consent.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guinea-Bissau
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03460002
Other Study ID Numbers  ICMJE RE-CAMP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bandim Health Project
Study Sponsor  ICMJE Bandim Health Project
Collaborators  ICMJE
  • Statens Serum Institut
  • Research Center for Vitamins and Vaccines
Investigators  ICMJE
Principal Investigator: Ane Fisker, MD, PhD Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Principal Investigator: Peter Aaby, DMSc,Professor Bandim Health Project, Guinea-Bissau and Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Principal Investigator: Aksel Jensen, PhD Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Principal Investigator: Anshu Varma, MSc Statens Serum Institute, Research Center for Vitamins and Vaccines, Bandim Health Project
Principal Investigator: Amabelia Rodrigues, Ph Bandim Health Project, Guinea-Bissau
PRS Account Bandim Health Project
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP