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NCT Number: NCT02294487

Study of the Immune Response After Vaccination in Multiple Myeloma Patients

This study will collect blood samples from healthy volunteers and volunteers with multiple myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus vaccines.

The main goal of the study is to start to identify differences in the immune response between multiple myeloma patients and people who don't have multiple myeloma. We hope this will provide important information about the best way and time to vaccinate multiple myeloma patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Infections Influenza, Human Lung Diseases Lymphoproliferative Disorders Myeloma, Multiple Myeloma-Multiple Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Orthomyxoviridae Infections Paraproteinemias Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aurora Health Care

Milwaukee, Wisconsin, 43233, United States

About this study

This study will consist of a prospective blood sample collection to gather baseline data to confirm antibody protection from vaccines in the Aurora Health Care multiple myeloma (MM) patients.

The overall goal of this study is to obtain a normative dataset for MM patients and non-MM control populations as well as determining baseline IgG levels to seasonal influenza A, influenza B, pneumococcal polysaccharide, and tetanus toxoid and confirmation of antibody protection from vaccines with assays based upon WHO standards of detection.

This is part of a series of studies designed to provide important information about the best way and time to vaccinate MM patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus and to gather additional information about MM and immune function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 years old or over
  • planning on getting the seasonal flu and/or pneumonia vaccine as part of normal care
  • have multiple myeloma, or don't have multiple myeloma and want to serve as a health control

Exclusion criteria

  • do not meet inclusion criteria

Treatment and study plan

Primary outcomes

  1. Evaluate composition of T cells, B cells, NK cell and monocyte populations from pre-vaccination though 24 weeks post-vaccination

    Time frame: 24 weeks

    Evaluate composition of T cells, B cells, NK cell and monocyte populations to identify immune suppression. Multiparameter flow cytometer will be used to evaluate T cells, B cells, and NK cell and monocyte populations using differentiation markers for the cell populations in subjects at five time points, baseline to 24 weeks.

  2. Measure of interferon -gamma in activated T cells from pre-vaccination though 24 weeks post-vaccination

    Time frame: 24 weeks

    Measure of interferon -gamma in activated T cells to evaluate T cell function. An intracellular interferon-gamma assay will be performed by incubating peripheral blood mononuclear cells overnight with an influenza antigen and evaluating the level of an intracellular interferon-y assay will be performed by incubating peripheral blood mononuclear cells overnight with an influenza antigen and evaluating the level of interferon -gamma in activated T cells. Vaccination should increase numbers of T cells producing interferon -gamma. Vaccination should increase numbers of T cells producing interferon -gamma.This evaluation will be done using blood drawn at 5 time points, including pre-vaccination and post vaccination at 2, 4, 12 and 24 weeks.

  3. Measure of antigen specific B cells from pre-vaccination though 24 weeks post-vaccination

    Time frame: 24 weeks

    Measure of antigen specific B cells to determine B cell responsiveness to the pneumococcal vaccine. Polysaccharides from various pathogenic strains will be conjugated to a fluorescent molecule such as fluorescein isothiocyanate (FITC). These constructs will be combined with B cell markers to evaluate pneumococcal specific B cells pre- and post-vaccination. If vaccination is successful, there should be an increase in antigen specific B cells.

  4. Total PnC-IgG, IgG2, PnC-IgG1 and IgG3 levels from pre-vaccination though 24 weeks post-vaccination

    Time frame: 24 weeks

    Total PnC-IgG levels and IgG2 levels will be determined by EIA using commercially available, FDA cleared kits (The Binding Site). PnC-IgG1 and IgG3 levels will be measured by ELISA using commercially available kits that we will modify in-house with optimized reagents for detection of IgG1 and IgG3 isotopes, standardized against a reference serum. This evaluation will be done using blood drawn at 5 time points, including pre-vaccination and post vaccination at 2, 4, 12 and 24 weeks.

  5. Evaluate both FcyRIIa and FcyRIII polymorphisms

    Time frame: up to 24 weeks

    Effectiveness of pneumococcal vaccines has an association with FcyRIIa that is expressed predominantly on phagocytic cells such as neutrophils and macrophages. There are no reports that suggest polymorphisms in FcyRIII are associated with improved efficacy of pneumococcal vaccines. However, therapeutic antibodies for the treatment of cancer such as rituximab have demonstrated that there is a survival advantage of individuals that have the FcyRIIa (H131R) and FcyRIII (V158F) polymorphisms. By evaluating both FcyRIIa and FcyRIII we can position ourselves to evaluate the use of vaccines and therapeutics in cancer.

Secondary outcomes

  1. Assess outcomes of MM patients after vaccination

    Time frame: up to 10 years

    Long term outcomes data will be collected from the medical record of MM patients in order to access the impact of vaccination on health outcomes.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Vince Lombardi Cancer Clinic

Registry information

Official study title

The Immune Response Following Vaccination in Multiple Myeloma Patients: A Prospective Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 19, 2014
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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