Immune Responses to COVID-19 Vaccination in Lymphoma Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma, High-grade B-cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Nodular Lymphocyte Predominant Hodgkin Lymphoma, Peripheral T-cell Lymphoma

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA 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) Patient must be ≥ 18 years. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hodgkin lymphoma<br>Diagnoses: Hodgkin lymphoma (classical Hodgkin lymphoma) | |
| Aggressive B-NHL<br>Diagnoses: Aggressive B-NHL (E.g. Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, Burkitt lymphoma, de novo transformed lymphoma, follicular lymphoma grade 3b) | |
| Indolent B-NHL<br>Diagnoses: Indolent B-NHL (E.g.follicular lymphoma grades 1-3a, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, nodular lymphocyte predominant Hodgkin lymphoma) | |
| Peripheral T/NK-cell<br>Diagnoses: Peripheral T/NK-cell lymphomas (any mature T/NK cell malignancy) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |