Immune Responses to COVID-19 Vaccination in Lymphoma Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04858568

Acronym

PROSECO

Enrollment

592

Registered

2021-04-26

Start date

2021-03-11

Completion date

2024-01-31

Last updated

2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

United Kingdom

Outcome results