Clinical trial NCT04858568: Immune Responses to COVID-19 Vaccination in Lymphoma Patients
Official title: PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time.
timeFrame: 12 months
Secondary outcomes:
measure: Comparison between SARS-CoV-2 IgG responses with clinical parameters.
timeFrame: 12 months
measure: Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: Bedfordshire Hospitals NHS Foundation Trust
state: Bedfordshire
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust
state: Hampshire
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Hereford
country: United Kingdom
facility: Wye Valley NHS Trust
state: Herefordshire
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
state: Tyne And Wear
Study officials:
References:
citation: 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.