Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study. (C-VELVET)

NHS Blood and Transplant

Status: Unknown

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT04954937

21AS0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 17 to 66 years old

Volunteers: Accepts Healthy Volunteers

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