Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab (Rituxivac)

St. Antonius Hospital

Status: Completed

Conditions: Non-Hodgkin Lymphoma (NHL)

Treatments: Biological: influenza vaccination with influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01707628

NL37320.100.11

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

Early group after rituximab

Active Comparator group

Description:

Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".

Treatment:

Biological: influenza vaccination with influenza vaccine

Late group after rituximab

Active Comparator group

Description:

Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".

Treatment:

Biological: influenza vaccination with influenza vaccine

Control group

Active Comparator group

Description:

Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

Treatment:

Biological: influenza vaccination with influenza vaccine