Immune Responses to COVID-19 Vaccination in Lymphoma Patients

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.

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Key information

Conditions

Classical Hodgkin Lymphoma Burkitt Lymphoma Chronic Disease Chronic Lymphocytic Leukemia DNA Virus Infections Diffuse Large B Cell Lymphoma Disease Attributes Epstein-Barr Virus Infections Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections High-grade B-cell Lymphoma Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders Mantle Cell Lymphoma Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Nodular Lymphocyte Predominant Hodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral T-cell Lymphoma Primary Mediastinal B Cell Lymphoma Small Lymphocytic Lymphoma Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bedfordshire Hospitals NHS Foundation Trust, Bedford, Bedfordshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.

Treatment and study plan

Primary outcomes

Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time.

Time frame: 12 months

To evaluate the robustness and persistence of anti-S IgG levels.

Secondary outcomes

Comparison between SARS-CoV-2 IgG responses with clinical parameters.

Time frame: 12 months

Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment.
Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.

Time frame: 12 months

To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration.

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PROSECO

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2024
First posted: Apr 26, 2021
Registry last updated: Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed