Immune Responses to COVID-19 Vaccination in Lymphoma Patients

Completed

• Conditions: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Nodular Lymphocyte Predominant Hodgkin Lymphoma; Primary Mediastinal B Cell Lymphoma; Follicular Lymphoma; Lymphoplasmacytic Lymphoma; Peripheral T-cell Lymphoma; Classical Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

• Registration Number: NCT04858568
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-26
• Primary Completion: 2022-10-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time.	12 months	To evaluate the robustness and persistence of anti-S IgG levels.

Secondary Outcome Measures

Name	Time	Method
Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.	12 months	To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration.
Comparison between SARS-CoV-2 IgG responses with clinical parameters.	12 months	Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment.

Trial Locations

Locations (9)

The Newcastle Upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle Upon Tyne, Tyne And Wear, United Kingdom

Wye Valley NHS Trust; 🇬🇧 Hereford, Herefordshire, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom

Bedfordshire Hospitals NHS Foundation Trust; 🇬🇧 Bedford, Bedfordshire, United Kingdom

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, Leicestershire, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom

Portsmouth Hospitals University NHS Trust; 🇬🇧 Portsmouth, Hampshire, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, Hampshire, United Kingdom