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NCT04954937 Clinical Trial

Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

Healthy Clinical Trial

— C-VELVET  

Official title:
Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04954937
Other study ID # 21AS0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2021
Est. completion date April 20, 2022

Study information
Verified date July 2021
Source NHS Blood and Transplant
Contact Lise Estcourt, MB BChir, DPhil
Phone 07823 351936
Email lise.estcourt@nhsbt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.

Description:

This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff). Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains. The results of this study will: 1. Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration. 2. Understand if antibody levels rebound to a concentration suitable for CCP and PFM. 3. Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners). 4. Assist in development of recording vaccination status on NHSBT databases of donors.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 20, 2022
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 66 Years
Eligibility Inclusion Criteria: - Individuals who have had a previous SARS-CoV-2 infection - Individuals who have previously donated COVID-19 convalescent plasma (CCP) - Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine) Exclusion Criteria: - Not received a SARS-CoV-2 vaccine

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom NHSBT - Birmingham Donation Centre Birmingham

Sponsors (1)
Lead Sponsor Collaborator
NHS Blood and Transplant

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in antibody levels post-vaccination assessed via Euroimmun assay Euroimmun assay at least 28 days following vaccination
Primary Increase in antibody levels post-vaccination assessed via Roche IgG assay Roche IgG assay at least 28 days following vaccination
Primary Increase in antibody levels post-vaccination assessed vial live virus neutralization Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants) at least 28 days following vaccination
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