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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
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
Secondary ID [1] 0 0
202011081
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cytokine (or chemokine) production in response to heterologous stimuli
Timepoint [1] 0 0
Around 60 to 90 days after last SARS-CoV-2 specific vaccine injection
Secondary outcome [1] 0 0
Neutralization assay
Timepoint [1] 0 0
Around 60 to 90 days after last SARS-CoV-2 specific vaccine injection

Eligibility
Key inclusion criteria
Inclusion/
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2021
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri

Funding & Sponsors
Primary sponsor type
Other
Name
Washington University School of Medicine
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04646239
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Michael S Avidan, MD
Address 0 0
Washington Univeristy School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries