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NCT04858568 Clinical Trial

Immune Responses to COVID-19 Vaccination in Lymphoma Patients

Chronic Lymphocytic Leukemia Clinical Trial

— PROSECO  

Official title:
PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04858568
Other study ID # RHM CAN1612
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2021
Est. completion date January 31, 2024

Study information
Verified date February 2024
Source University Hospital Southampton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational study aims to evaluate the robustness and persistence of immune responses to vaccination, define factors associated with impaired immune responses and assess the incidence of COVID-19 infections in vaccinated individuals. To do this, we will collect peripheral blood from patients with lymphoid cancers before and after their COVID-19 vaccination. The blood will be explored in the laboratory for antibodies to SARS-CoV-2 and T-cell responses to the spike protein. Detailed clinical information will also be collated on about their cancer and treatment.

Recruitment information / eligibility
Status Completed
Enrollment 592
Est. completion date January 31, 2024
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility INCLUSION CRITERIA 1. Patients having a confirmed diagnosis of either: A) Hodgkin lymphoma B) Aggressive B-cell lymphoma (e.g. Burkitt's lymphoma, diffuse large B-cell lymphoma, grade 3b follicular lymphoma, de novo transformed follicular lymphoma) C) Indolent B-cell lymphoma (e.g. all grades of follicular lymphoma except grade 3b, marginal zone lymphoma, lymphoplasmacytic lymphoma, chronic or small lymphocytic lymphoma, mantle cell lymphoma) D) Mature T/NK-cell malignancy (any subtype) 2. Patient must be = 18 years. 3. Patients will have provided written Informed Consent. EXCLUSION CRITERIA 1) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Bedfordshire Hospitals NHS Foundation Trust Bedford Bedfordshire
United Kingdom Wye Valley NHS Trust Hereford Herefordshire
United Kingdom University Hospitals of Leicester NHS Trust Leicester Leicestershire
United Kingdom The Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle Upon Tyne Tyne And Wear
United Kingdom Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich Norfolk
United Kingdom Nottingham University Hospitals NHS Trust Nottingham Nottinghamshire
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire
United Kingdom Portsmouth Hospitals University NHS Trust Portsmouth Hampshire
United Kingdom University Hospital Southampton NHS Foundation Trust Southampton Hampshire

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time. To evaluate the robustness and persistence of anti-S IgG levels. 12 months
Secondary Comparison between SARS-CoV-2 IgG responses with clinical parameters. Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment. 12 months
Secondary Symptomatic COVID-19 with positive SARS-CoV-2 PCR results. To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration. 12 months
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