Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

NCT01707628 — Not applicable, Completed, 98 participants, St. Antonius Hospital

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Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab

Registry	NCT01707628, acronym Rituxivac
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, prevention
Enrollment	98 (Actual)
Sponsor	St. Antonius Hospital (Other)
Conditions	Non-Hodgkin Lymphoma (NHL)
Interventions	influenza vaccination with influenza vaccine (Biological)
Dates	start 2012-10-01, primary completion 2013-06-01, completion 2013-06-01, first posted 2012-10-16, last updated 2014-01-31
Locations	7 sites in Netherlands

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Early group after rituximab	Active comparator	Biological: influenza vaccination with influenza vaccine	Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
Late group after rituximab	Active comparator	Biological: influenza vaccination with influenza vaccine	Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
Control group	Active comparator	Biological: influenza vaccination with influenza vaccine	Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

influenza vaccination with influenza vaccine (Biological), also known as Influvac, Vaxigrip

+Outcome measures

Primary outcomes

Influenza antibody titre [3 weeks after vaccination]

Secondary outcomes

number of memory B cells [6 months]
lymphocyte subsets [6 months]
immunoglobulin levels [6 months]
IgG subclasses [6 months]
production of IFN-γ by CD4+ cells [6 months]
Cytokines [6 months]
genetic factors [6 months]

+Eligibility

Sex: All, ages: 18 Years to any, 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.

+Locations (7)

Facility	City	Country
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
Reinier de Graaf Groep	Delft, South Holland	Netherlands
Albert Schweitzer Hospital	Dordrecht, South Holland	Netherlands
St. Antonius Hospital	Nieuwegein, Utrecht	Netherlands

+Investigators

Minke AE Rab, Drs., Principal investigator, St. Antonius Hospital