The questions to be answered are:1. Is vaccination with trivalent inactivated influenza vaccine in MGUS patients useful? ; Do these patients elicit adequate humoral and cellular T-cell responses after influenza vaccination?2. What is the B cell…
ID
Source
Brief title
Condition
- Plasma cell neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Humoral immune response will be determined by the Haemagluttination inhibition
test and respose is defined by the achievement of titres >40, which are
considered protective.
Enzyme linked ImmunoSPOT (ELIspot) will also quantify influenza specific B cell
response.
the cellular immune response will be measured by Intracellular Cytokine (i.e.
IFN*, IL-2 and TNFα) detection by Flow Cytometry and assessment of
proliferation of CD4 and CD8 T cells by Flow Cytometry.
these parameters in patients will be compared to healthy controls
Secondary outcome
not applicable
Background summary
Monoclonal Gammopathy of Undetermined Significance (MGUS) is a pre-malignant
condition characterised by the limited clonal expansion of transformed bone
marrow plasma cells with no clinical manifestations. MGUS is present in 3% of
people over 50 and has a lifelong risk of progression to Multiple Myeloma or
related plasma cell disorders.
Vaccination against influenza is recommended for the elderly and is not
contraindicated in MGUS. However, there is little information concerning the
efficacy of vaccination in MGUS. The humoral response to infection in MGUS
patients is also unclear. They have normal levels of polyclonal immunoglobulins
in the serum but the degree of immunosuppression if at all is unknown and
therefore it is unclear whether they have compromised humoral response. To our
knowledge, no studies have been published on the efficacy of vaccination
against influenza virus with he currently used subunit vaccines in MGUS
patients.
In this context, we designed a study protocol to determine the humoral and
cell-mediated immune responses following influenza vaccination.
Study objective
The questions to be answered are:
1. Is vaccination with trivalent inactivated influenza vaccine in MGUS patients
useful? ; Do these patients elicit adequate humoral and cellular T-cell
responses after influenza vaccination?
2. What is the B cell proliferation relation to clonal growth? ; What happens
to the plasma cell clones after vaccination?
Study design
This is an observational study whereby the humoral and cell-mediated immune
responses will be determined in MGUS patients at 4 time-points following
vaccination with the influenza virus subunit vaccine for the season 2010-2011,
and compared with the responses measured in Multiple Myeloma patients and
healthy controls.
Intervention
not applicable
Study burden and risks
You will get the flu shot and are therefore possibly protected against
influenza illness, but whether that actually is so is part of this research. In
addition, you do not have a direct personal interest in the case of
participation in this research. The extra outpatient clinic visit can be an
additional burden for you. In addition, there is in total 240 ml of blood to be
drawn.
A Deusinglaan 1, umcg, building 3215
9713av
NL
A Deusinglaan 1, umcg, building 3215
9713av
NL
Listed location countries
Age
Inclusion criteria
Patients/controls
- (MGUS patients only)patients have to fulfill the diagnostic criteria for MGUS
- serum M protein<30g/L
- Clonal plasma cells in bone marrow <10%
- No myeloma related dysfunction
- No other B-cell proliferative disease
-informed consent;Multiple Myeloma inclusion criteria
- patients who fulfill the diagnostic criteria for multiple myeloma
- Monoclonal plasma cells in bone marrow >10% and/or presence of biopsy proven plasmacytoma
- Monoclonal protein present in serum and/or urine
-Myeloma related organ dysfunction
o Calcium elevation in the blood S. Calcium >10.5 mg/l or upper limit of normal
o Renal insufficiency: S. Creatinine > 2 mg/dl
o Anemia Hemoglobin < 10 g/dl or 2 g < normal
o Lytic bone lesions or osteoporosis
-Patients with stage 1 myeloma (according to the International Staging System)
o Serum β2-MG* <3.5 mg/L
o Serum albumin >=3.5 g/dl
-Informed consent
Exclusion criteria
MGUS patients/ healthy controls
- age under 18 years
- current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment
- influenza vaccination within the 6 months prior to the study
- pregnancy
- malignancy
- known allergy to or former severe reaction following Influvac®;Multiple Myeloma Exclusion criteria
- Patients in late stage disease
- Patients who have undergone stem cell transplantation
- current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment
- pregnancy
- known allergy to or former severe reaction following Influvac®
Design
Recruitment
Medical products/devices used
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 | EUCTR2010-022693-14-NL |
| CCMO | NL33206.042.10 |