Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

NCT ID: NCT04954937

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-04-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Blood and Transplant

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lise Jane Estcourt

Haematologist Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lise Estcourt, MB BChir, DPhil

Role: PRINCIPAL_INVESTIGATOR

NHS Blood and Transplant

Locations

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NHSBT - Birmingham Donation Centre

Birmingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Lise Estcourt, MB BChir, DPhil

Role: CONTACT

07823 351936

Ana Mora, PhD

Role: CONTACT

00 44 7889304288

Facility Contacts

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Richard Brain

Role: primary

Other Identifiers

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21AS0001

Identifier Type: -

Identifier Source: org_study_id

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