Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

• Conditions: Healthy

• Registration Number: NCT04954937
• Lead Sponsor: NHS Blood and Transplant

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-15
• Primary Completion: 2021-10-20
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in antibody levels post-vaccination assessed via Roche IgG assay	at least 28 days following vaccination	Roche IgG assay
Increase in antibody levels post-vaccination assessed vial live virus neutralization	at least 28 days following vaccination	Live virus neutralization (SARS-CoV-2 wild type (WT), alpha,beta and delta variants)
Increase in antibody levels post-vaccination assessed via Euroimmun assay	at least 28 days following vaccination	Euroimmun assay

Trial Locations

Locations (1)

NHSBT - Birmingham Donation Centre; 🇬🇧 Birmingham, United Kingdom