A study of humoral and cellular-mediated immune response in Monoclonal gammopathy of Undetermined Significance after vaccination with trivalent inactivated influenza vaccine (influvac)

A study of humoral and cellular-mediated immune response in Monoclonal gammopathy of Undetermined Significance after vaccination with trivalent inactivated influenza vaccine (influvac) - mgus-vacc respons

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34204

Enrollment

122

Registered

2010-09-14

Start date

2010-10-26

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MGUS Monoclonal gammopathy of undetermined significance

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients/controls - (MGUS patients only)patients have to fulfill the diagnostic criteria for MGUS - serum M protein10% 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 =3.5 g/dl -Informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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 TNFa) 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	—

Measure

Time frame

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 TNFa) 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

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Countries

Netherlands

Outcome results