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

Sponsor

NHS Blood and Transplant (Other)

Overall Status

Recruiting

CT.gov ID

NCT04954937

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy

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:

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.
Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
Assist in development of recording vaccination status on NHSBT databases of donors.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Convalescent Plasma Donor Vaccine Study: An Observational Antibody Level Study

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Oct 20, 2021

Anticipated Study Completion Date :

Apr 20, 2022

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 66 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHSBT - Birmingham Donation Centre	Birmingham		United Kingdom

Sponsors and Collaborators

NHS Blood and Transplant

Investigators

Principal Investigator: Lise Estcourt, MB BChir, DPhil, NHS Blood and Transplant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lise Jane Estcourt, Haematologist Consultant, NHS Blood and Transplant

ClinicalTrials.gov Identifier:

NCT04954937

Other Study ID Numbers:

21AS0001

First Posted:

Jul 8, 2021

Last Update Posted:

Jul 15, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lise Jane Estcourt, Haematologist Consultant, NHS Blood and Transplant

Anti-SARS-CoV-2 antibodies

COVID-19

Convalescent plasma

Study Results

No Results Posted as of Jul 15, 2021