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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04646239
Registration number
NCT04646239
Ethics application status
Date submitted
20/11/2020
Date registered
27/11/2020
Date last updated
26/11/2021
Titles & IDs
Public title
Biomarkers of Trained Immunity Following MMR Vaccination
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Scientific title
Determining Biomarkers of Trained Immunity in a Randomized Controlled Trial of the Measles, Mumps, and Rubella Vaccine - a Sub-study of the CROWN CORONATION Trial
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Secondary ID [1]
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202011081
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Covid19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Heterologous stimuli
Diagnosis / Prognosis - Neutralization assay
Participants in the CROWN CORONATION trial - The CROWN CORONATION trial will randomly allocate adult participants to a single intramuscular injection of MMR vaccine or Placebo (0.9% saline). All participants in this sub-study receive SARS-CoV-2 specific vaccine subsequent to the MMR or Placebo injection.
Diagnosis / Prognosis: Heterologous stimuli
In vitro exposure of peripheral blood mononuclear cells to heterologous stimuli
Diagnosis / Prognosis: Neutralization assay
In vitro measurement of neutralizing antibody activity to wild-type SARS-CoV-2
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cytokine (or chemokine) production in response to heterologous stimuli
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Assessment method [1]
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Cytokines such as TNF-a, IL-1ß and IL-6 produced by human monocytes, and IFN-? produced by natural killer (NK)-cells, are markers of trained immunity and these (and other cytokines and chemokines) will be measured in supernatants of stimulated PBMCs from a cohort of participants in the CROWN CORONATION trial. All cytokines and chemokines are measured in picograms/milliliter.
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Timepoint [1]
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Around 60 to 90 days after last SARS-CoV-2 specific vaccine injection
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Secondary outcome [1]
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Neutralization assay
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Assessment method [1]
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Neutralizing antibody activity to wild-type SARS-CoV-2
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Timepoint [1]
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Around 60 to 90 days after last SARS-CoV-2 specific vaccine injection
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Eligibility
Key inclusion criteria
Inclusion/
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Prospective participant must already be enrolled into the CROWN CORONATION trial at the
sub-study location. Refer to NCT04333732 for list of inclusion / exclusion criteria for the
study population.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/06/2021
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Sample size
Target
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Accrual to date
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Final
96
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Missouri
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Funding & Sponsors
Primary sponsor type
Other
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Name
Washington University School of Medicine
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a substudy of NCT04333732. The goal of this sub-study is to identify and characterize
biomarkers of trained immunity by measuring, in vitro, immune responses to heterologous
products, especially viral associated products, in the MMR vaccinated compared placebo
groups.
All participants are randomly assigned to MMR or placebo injection at baseline, followed by
SARS-CoV-2 specific vaccination. Blood is drawn around 60 to 90 days after the last
SARS-CoV-2 specific vaccine injection.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04646239
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Michael S Avidan, MD
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Address
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Washington Univeristy School of Medicine
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04646239
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