Convalescent Plasma Donor Vaccine Study An Observational... | NCT04954937

Studies
Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

NCT04954937

Sponsor

NHS Blood and Transplant

Status

Unknown status

Last Update Posted

Jul 15, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2021Actual

Primary Completion Date

Oct 20, 2021Estimated

Completion Date

Apr 20, 2022Estimated

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jul 7, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2021

Last Update Posted Date

Jul 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lise Jane Estcourt, Haematologist Consultant, NHS Blood and TransplantPrincipal Investigator

Lead Sponsor

NHS Blood and TransplantOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

66 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise Estcourt, MB BChir, DPhil	Contact	07823 351936		lise.estcourt@nhsbt.nhs.uk
Ana Mora, PhD	Contact	00 44 7889304288		ana.mora@nhsbt.nhs.uk

Overall Officials

Name	Affiliation	Role
Lise Estcourt, MB BChir, DPhil	NHS Blood and Transplant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHSBT - Birmingham Donation Centre	Recruiting	Birmingham			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

N/A- Individual participant data will note be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Two EDTA samples will be collected from each donor. First sample will be analysed for SARS-CoV-2 IgG antibodies using EUROimmun assay. A second sample will be analysed for SARS-CoV-2 neutralising antibody testing and ELISA or other immunological assays for anti-S antibodies using SARS-CoV-2 strains.