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

February 28, 2021 updated by: Bandim Health Project

A Cluster Randomized Controlled Trial on the Campaign Effect of Measles Vaccine and Oral Polio Vaccine on General Hospital Admissions and Mortality Among Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Enrolment to end of study (longest follow-up 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Enrolment to end of study (longest follow-up 2 years)
Death (registered through follow-up visits, verified by verbal autopsies)
Enrolment to end of study (longest follow-up 2 years)
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)
Enrolment to end of study (longest follow-up 2 years)
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
Enrolment to end of study (longest follow-up 2 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One-two months after a child is included in the study
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.
Two months after a child is included in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Collaborators

Statens Serum Institut
Research Center for Vitamins and Vaccines

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

March 4, 2018

First Posted (ACTUAL)

March 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE-CAMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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