Biomarkers of Trained Immunity Following MMR Vaccination
NCT ID: NCT04646239
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2020-12-17
2021-06-28
Brief Summary
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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.
Detailed Description
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A secondary objective is comparison of SARS-CoV-2 neutralization assays between MMR and placebo comparison groups around 60 to 90 days after the last SARS-CoV-2 specific vaccine injection.
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. Peripheral blood mononuclear cells (PMBC) will be isolated from samples and stimulated with heterologous products (for example; Roswell Park Memorial Institute medium \[RPMI; negative control\], MMR \[the vaccine itself as specific stimulus\], severe acute respiratory syndrome coronavirus-2 \[SARS-CoV-2; heat inactivated\], influenza virus \[heat inactivated\], toll-like receptor 3 ligand \[TLR3 ligand; poly I:C\], toll-like receptor 7/8 ligand \[TLR7/8 ligand; R848\], toll-like receptor 4 ligand \[TLR4 ligand; lipopolysaccharide (LPS)\]). Supernatants will be assayed by multiplex luminex protein assay at 24 hr (for example; type I interferons \[IFN\], interleukin \[IL\]-1β , IL-6, tumor necrosis factor \[TNF\]-α) and after 5 days (for example; IFN-γ, IL-17, IL-22, IL-10). This process of testing stimulus-response will be conducted on both the baseline and day 30 samples, collected from both the MMR and Placebo groups.
Neutralization assay will be conducted on all samples using wild-type SARS-CoV-2.
Measles IgG titres will be measured on all samples. Measles IgG titres will be used for sensitivity analysis.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Heterologous stimuli
In vitro exposure of peripheral blood mononuclear cells to heterologous stimuli
Neutralization assay
In vitro measurement of neutralizing antibody activity to wild-type SARS-CoV-2
Interventions
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Heterologous stimuli
In vitro exposure of peripheral blood mononuclear cells to heterologous stimuli
Neutralization assay
In vitro measurement of neutralizing antibody activity to wild-type SARS-CoV-2
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
18 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Michael Avidan
Professor
Principal Investigators
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Michael S Avidan, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Univeristy School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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202011081
Identifier Type: -
Identifier Source: org_study_id