To study the immune response to vaccination with influenza virus vaccine, conjugated Hib and pneumococcal vaccine after treatment with rituximab in association with the reconstitution of immune function (in terms of amount of B-cells and…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Antibody titres against S. pneumoniae and H. influenzae type b (in µg/mL) and
the influenza virus before and after vaccination. The association between the
reconstitution of immune function after treatment with rituximab (in terms of
amount of B-cells and immunoglobulin levels) and the rise in antibody titre.
Secondary outcome
o The effect of the use of growth factor during chemotherapy on the response to
vaccination
o The relationship between time since last rituximab-dose and the rise in
antibody titre
Background summary
Rituximab is a chimeric anti-CD20 monoclonal antibody used in combination with
chemotherapy for the treatment of non-Hodgkin*s lymphoma (NHL). Following
infusion with rituximab, B-cell depletion from the peripheral blood occurs
within days. Levels of normal peripheral B-cells remain low for 2-6 months.
Because of the immunosuppressive (chemo) therapy, patients are prone to develop
infections with encapsulated bacteria such as Streptococcus pneumoniae and
Haemophilus influenzae (Hib). Vaccination against these bacteria and the
influenza virus is therefore recommended for these immunocompromised patients.
Little is known about the effect of rituximab on the response to vaccination.
In this study the humoral and cellular immune-response to vaccination is
investigated in patients with non-Hodgkin*s lymphoma who were treated with
rituximab.
Study objective
To study the immune response to vaccination with influenza virus vaccine,
conjugated Hib and pneumococcal vaccine after treatment with rituximab in
association with the reconstitution of immune function (in terms of amount of
B-cells and immunoglobulin levels).
Study design
The design is a non-randomised cohort study. A total of hundred-forty (140)
patients with non-Hodgkin*s lymphoma, who were treated with rituximab in the
last twelve months before start of the study and are in remission, will be
included.
Intervention
all patients will receive the pneumococcal conjugate vaccine Prevnar®, the Hib
conjugate vaccine Act-Hib®, the influenza virus vaccine Influvac® and the
pneumococcal polysaccharide vaccine Pneumovax®23. All vaccines will be used in
the authorised forms according to existing vaccination protocols in
immunocompromised patients.
Study burden and risks
Patients will be vaccinated at three different moments with vaccines that are
indicated for this patient group according to existing vaccination protocols.
Blood samples will be drawn before the first vaccination and three weeks after
each vaccination, so four blood samples will be drawn. If possible, vaccination
will be integrated in normal out-patient clinical visits. All vaccines will be
used in their authorised forms and for their authorised purpose, therefore no
additional risks are to be expected. Patient discomfort might consist of a
painful arm/leg after vaccination. Benefit is protection against infections
with encapsulated bacteria such as Streptococcus pneumoniae and Haemophilus
influenzae (Hib); bacteria which are known to cause serious infections in
immunocompromised patients.
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Koekoekslaan 1
3435 CM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with non-Hodgkin's lymphoma, treated with rituximab (approximately 6-8 cycles) and who are in remission.
- Completion of rituximab therapy in the last twelve months before start of the study
- Age 18 years or older
- Signing of informed consent
Exclusion criteria
- Vaccination with Hib or pneumococcal vaccine in the last fifteen months before start of the study
- Fever at time of vaccination
- Previous/known allergic reaction to any of the components of the vaccines given
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006712-37-NL |
| CCMO | NL25457.000.08 |