Immune Responses to COVID-19 Vaccination in Lymphoma Patients
PROSECO
PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
1 other identifier
observational
592
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2021
CompletedFirst Submitted
Initial submission to the registry
April 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 6, 2024
February 1, 2024
1.6 years
April 22, 2021
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparison between SARS-CoV-2 IgG responses with clinical parameters.
12 months
Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.
12 months
Study Arms (4)
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)
Eligibility Criteria
All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.
You may qualify if:
- 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.
You may not qualify if:
- \) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Bedfordshire Hospitals NHS Foundation Trust
Bedford, Bedfordshire, MK42 9DJ, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Wye Valley NHS Trust
Hereford, Herefordshire, HR1 2ER, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Related Publications (1)
Lim SH, Stuart B, Joseph-Pietras D, Johnson M, Campbell N, Kelly A, Jeffrey D, Turaj AH, Rolfvondenbaumen K, Galloway C, Wynn T, Coleman AR, Ward B, Long K, Coleman H, Mundy C, Bates AT, Ayres D, Lown R, Falconer J, Brake O, Batchelor J, Willimott V, Bowzyk Al-Naeeb A, Robinson L, O'Callaghan A, Collins GP, Menne T, Faust SN, Fox CP, Ahearne M, Johnson PWM, Davies AJ, Goldblatt D. Immune responses against SARS-CoV-2 variants after two and three doses of vaccine in B-cell malignancies: UK PROSECO study. Nat Cancer. 2022 May;3(5):552-564. doi: 10.1038/s43018-022-00364-3. Epub 2022 Mar 24.
PMID: 35332334DERIVED
Biospecimen
Plasma Serum Peripheral blood mononuclear cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2021
First Posted
April 26, 2021
Study Start
March 11, 2021
Primary Completion
October 31, 2022
Study Completion
January 31, 2024
Last Updated
February 6, 2024
Record last verified: 2024-02