Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04954937

Acronym

C-VELVET

Enrollment

100

Registered

2021-07-08

Start date

2021-04-20

Completion date

2022-04-20

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Anti-SARS-CoV-2 antibodies, COVID-19, Convalescent plasma

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to 66 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Increase in antibody levels post-vaccination assessed via Euroimmun assay	at least 28 days following vaccination	Euroimmun assay
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)

Countries

United Kingdom

Contacts

Primary ContactLise Estcourt, MB BChir, DPhil

lise.estcourt@nhsbt.nhs.uk07823 351936

Backup ContactAna Mora, PhD

ana.mora@nhsbt.nhs.uk00 44 7889304288

Outcome results