Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.
C-VELVET
1 other identifier
observational
100
1 country
1
Brief Summary
There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2021
CompletedFirst Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedJuly 15, 2021
July 1, 2021
6 months
June 29, 2021
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Eligibility Criteria
Healthy volunteers
You may qualify if:
- 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)
You may not qualify if:
- Not received a SARS-CoV-2 vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NHSBT - Birmingham Donation Centre
Birmingham, United Kingdom
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lise Estcourt, MB BChir, DPhil
NHS Blood and Transplant
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Haematologist Consultant
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 8, 2021
Study Start
April 20, 2021
Primary Completion
October 20, 2021
Study Completion
April 20, 2022
Last Updated
July 15, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share
N/A- Individual participant data will note be shared.