Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

St. Antonius Hospital98 enrolled

Overview

The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Non-Hodgkin Lymphoma (NHL)

Interventions

influenza vaccination with influenza vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission. 2. Completion of rituximab therapy in the last twelve months before start of the study. 3. Age ≥ 18 years. 4. Signing of informed consent. Exclusion Criteria: 1. Completion of rituximab therapy 7-8 months before start of the study. 2. Fever at time of vaccination. 3. Previous/known allergic reaction to any of the components of the vaccines given.

Locations (7)

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Onze Lieve Vrouwen Gasthuis

Amsterdam, North Holland, Netherlands

Medisch Spectrum Twente

Enschede, Overrijssel, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Outcomes

Primary Outcomes

Influenza antibody titre

Time frame: 3 weeks after vaccination

Secondary Outcomes

number of memory B cells

Time frame: 6 months

lymphocyte subsets

Time frame: 6 months

immunoglobulin levels

Time frame: 6 months

IgG subclasses

Time frame: 6 months

production of IFN-γ by CD4+ cells

Time frame: 6 months

Cytokines

Time frame: 6 months

genetic factors

Time frame: 6 months

Data from ClinicalTrials.gov

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