NCT05171959|Unknown
Platelet and Immune Response in Covid-19 Vaccine
Vax-SPEED-IT
Characterization of the Platelet and Immune Response in Adults Receiving SARS-CoV-2 Vaccine
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Vax-SPEED-IT
Characterization of the Platelet and Immune Response in Adults Receiving SARS-CoV-2 Vaccine
Sponsor study identifier
observational
32
1 country
1
Study Start
May 5, 2021
Actual (reported)Primary Completion
February 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
COVID-19 mRNA vaccines, administered with a two-dose regimen, have been shown to provide protection against Covid-19. However, the thromboinflammatory response toward these vaccines has never been explored as they exploit a completely new technology. It was reported that mRNA vaccines are highly reactogenic right after vaccine administration in particular in young adults, but we do not know which cells drive the early immune response to LNP-mRNA vaccines in humans and if platelets become activated as well. Moreover, it is not known if female, who have a heightened immune response to other vaccines, are able to mount a faster response to this new type of vaccines. Objectives of the study is to characterize the platelet and immune response and the platelet-immune cross-talk in subjects undergoing SARS-CoV-2 vaccination.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2021
Actual (reported)December 27, 2021
Actual (reported)December 29, 2021
Actual (reported)February 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Platelet-leukocytes aggregates quantification
Percentage of platelet-leukocytes aggregates (PLA) among blood leukocytes. PLA are identified based on the expression of CD41a in the individual leukocyte subpopulations.
6 months
Cytokine Array in plasma
6 months
Detection of Circulating SARS-Cov-2 Neutralization Antibodies
6 months
Platelet Phenotypic and Functional Analysis
6 months
Soluble markers of platelet activation: sP-selectin, sCD40L.
6 months
Pro-Inflammatory Chemokines
6 months
We will enrol 32 female and male (1:1) volunteers without signs of infection who will be subjected to SARS-CoV-2 Vaccination. Enrolled healthy volunteers will be asked to undergo venous blood withdrawals at the following time-points: * T0: 0-24 hours before the first dose of the vaccine; * T1: 72±24 hours after the first dose of vaccine administration; * T2: 10±2 days after first dose of vaccine administration; * T3: 0-24 hours before the second dose of vaccine; * T4: 72±24 hours after second dose of vaccine administration; * T5: 10±2 days after second dose of vaccine administration.
Sapienza University of Rome
Roma, 00161, Italy
Anticoagulated whole blood, serum, plasma
Roberto Cangemi, MD
University of Roma La Sapienza
Stefania Basili, MD
University of Roma La Sapienza
First Submitted
December 27, 2021
First Posted
December 29, 2021
Study Start
May 5, 2021
Actual (reported)Primary Completion
February 15, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 29, 2021
Record last verified: 2021-12
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