Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646239
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-11-20
Brief Title:
Biomarkers of Trained Immunity Following MMR Vaccination
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
A sub-study of the CROWN CORONATION Trial COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION 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 virally associated products in those exposed to MMR vaccine injection compared to those exposed to 09 sodium chloride normal saline placebo injection
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 IC toll-like receptor 78 ligand TLR78 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
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 IC toll-like receptor 78 ligand TLR78 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None