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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460002
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Statens Serum Institut
Research Center for Vitamins and Vaccines
Information provided by (Responsible Party):
Bandim Health Project

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.


Condition or disease Intervention/treatment Phase
Measles Vaccination Oral Polio Vaccine Non-specific/Heterologous Effects of Vaccines Mortality Morbidity Children Biological: Measles vaccine Biological: Oral polio vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28000 participants
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
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
Study Start Date : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019


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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Enrolment to end of study (longest follow-up 2 years) ]
    Death (registered through follow-up visits, verified by verbal autopsies)

  2. 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)

  3. 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


Other Outcome Measures:
  1. 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

  2. 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.



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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460002


Contacts
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Contact: Amabelia Rodrigues, PhD a.rodrigues@bandim.org
Contact: Ane Fisker, MD, PhD abf@ssi.dk

Locations
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Guinea-Bissau
Bandim Health Project Recruiting
Bissau, Guinea-Bissau
Contact: Ane Fisker, MD       a.fisker@bandim.org   
Sponsors and Collaborators
Bandim Health Project
Statens Serum Institut
Research Center for Vitamins and Vaccines
Investigators
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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:
World Health Organization. Global measles and rubella strategic plan: 2012-2020. 2012.
World Health Organization. Polio eradication and endgame strategic plan: 2013-2018. 2013.
Andersen A, Fisker AB, Rodrigues A, et al. National immunization campaigns with oral polio vaccine (OPV) reduce the general all-cause mortality rate: An analysis of the effect of campaign-OPV on child mortality within seven randomised trials (submitted). 2016.
Byberg S., Thysen SM, Rodrigues A et al. A general measles vaccination campaign and subsequent child mortality in urban Guinea-Bissau (manuscript).
World Bank. World Bank Countries and Lending Groups. https://datahelpdesk.worldbank.org/knowledgebase/articles/906519 (accessed 01-07-2016).
United Nations Inter-agency Group for Child Mortality Estimation. http://www.childmortality.org/index.php?r=site/graph#ID=GNB_Guinea-Bissau (accessed 01-07-2016)
INDEPTH network. Indepth Verbal Autopsy. http://www.indepth-network.org/resources/tools (accessed 25-07-2016).
World Health Organization. Information Sheet Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines. 2014. http://www.who.int/vaccine_safety/initiative/tools/MMR_vaccine_rates_ information_sheet.pdf (accessed 01-07-2016).
World Health Organization. Information Sheet Observed Rate of Vaccine Reactions Polio Vaccines. 2014. http://www.who.int/vaccine_safety/initiative/tools/Polio_vaccine_rates_information_sheet.pdf (accessed 01-07-2016).
Strebel PM, Papania MJ, Dayan GH, Halsey NA. Measles Vaccine. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines: Saunders; 2008: 353-98.
Higgins JPT, Soares-Weiser K, Reingold A. Systematic review of the non-specific effects of BCG, DTP and measles containing vaccines . Available at: http://www.who.int/immunization/sage/meetings /2014/april/3_NSE_Epidemiology_review_Report_to_SAGE_14_Mar_FINAL.pdf?ua=1, 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT03460002    
Other Study ID Numbers: RE-CAMP
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bandim Health Project:
Measles vaccine
Oral polio vaccine
Campaign
Child mortality
Child morbidity
Non-specific effects
Additional relevant MeSH terms:
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Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs