Immune Responses to COVID-19 Vaccination in Lymphoma Patients (PROSECO)

February 5, 2024 updated by: University Hospital Southampton NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK42 9DJ
        • Bedfordshire Hospitals NHS Foundation Trust
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS foundation Trust
    • Herefordshire
      • Hereford, Herefordshire, United Kingdom, HR1 2ER
        • Wye Valley NHS Trust
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Hospitals Nhs Trust
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Hodgkin lymphoma

Diagnoses:

Hodgkin lymphoma (classical Hodgkin lymphoma)
Aggressive B-NHL

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

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

Diagnoses:

Peripheral T/NK-cell lymphomas (any mature T/NK cell malignancy)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RHM CAN1612

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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