Platelet and Immune Response in Covid-19 Vaccine

NCT05171959 | Unknown

• 1 other identifier: PLTCOVAX
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2 Vaccination

Keywords

SARS-CoV-2; Covid-19; Vaccine; Platelets; Immunity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Volunteers without signs of SARS-CoV2 infection who will be subjected to SARS-CoV-2 Vaccination

You may not qualify if:

• Anti-platelet or anti-coagulant medications in the past 10 days
• Autoimmune disease
• Reported severe immunosuppression
• Pregnancy or breastfeeding
• Recent transfusions of platelets or plasma

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Lucia Stefanini: collaborator
• Stefania Basili: collaborator

Study Sites (1)

Sapienza University of Rome

Roma, 00161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anticoagulated whole blood, serum, plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberto Cangemi, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Stefania Basili, MD

  University of Roma La Sapienza

  STUDY CHAIR

Central Study Contacts

Lucia Stefanini, PhD

CONTACT

+393914747595; lucia.stefanini@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Roberto Cangemi

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: May 5, 2021
• Primary Completion: February 15, 2022
• Study Completion: April 15, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

IT (1)