Study of the Immune Response After Vaccination in Multiple Myeloma Patients

NCT02294487 | Completed

• 1 other identifier: MMvax-pilot
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Multiple Myeloma; Myeloma, Multiple; Myeloma-Multiple

Keywords

influenza; pneumococcal; pneumonia; vaccine; immunization; #CAImmun; Immuno-oncology; supportive care; vaccination; meningococcal; HIB

Outcome Measures

Primary Outcomes (5)

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

  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.

  24 weeks

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

  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.

  24 weeks

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

  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.

  24 weeks

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

  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.

  24 weeks

• Evaluate both FcyRIIa and FcyRIII polymorphisms

  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.

  up to 24 weeks

Secondary Outcomes (1)

• Assess outcomes of MM patients after vaccination

  up to 10 years

Study Arms (1)

Subjects

Individuals over 50 who are going to get the seasonal flu vaccine, pneumococcal, HIB, and/or meningococcal vaccination and either have multiple myeloma or do not have multiple myeloma.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple myeloma patients and age and sex matched control subjects over 50 who are already planning to have the flu and/or pneumonia vaccine as part of normal care. The control group is important for comparison of age-adjusted changes in immune responses to vaccination.

You may qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Vince Lombardi Cancer Clinic: collaborator

Study Sites (1)

Aurora Health Care

Milwaukee, Wisconsin, 43233, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Influenza, Human; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Thompson, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 19, 2014
• Study Start: December 30, 2014
• Primary Completion: January 28, 2016
• Study Completion: August 10, 2017
• Last Updated: October 3, 2024

Record last verified: 2019-02

Locations

US (1)