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OpenTrials
Completed

NCT Number: NCT02267733

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients

A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

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Key information

Conditions

Influenza Gammopathy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Understand and voluntarily sign an informed consent document
  • Age >= 18 years at the time of signing the informed consent form
  • Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM)

Exclusion criteria

  • An serious egg allergy or prior serious adverse reaction to an influenza vaccine
  • Use of any other influenza vaccine for the 2014 to 2015 flu season
  • Women who are pregnant or plan to become pregnant in the study period

Treatment and study plan

Fluzone

Drug

Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration

Other names: Fluzone High Dose

Primary outcomes

  1. Rate of Disease Control

    Time frame: up to 10 months

    Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria

Secondary outcomes

  1. Influenza related morbidity rate

    Time frame: up to 10 months

    Measure the rate of influenza related morbidity at the end of the flu season

  2. Serologic Protection Rate after initial vaccine

    Time frame: 30 days post vaccine

    Evaluate rates of serologic protection (defined as HAI titer > 40) following initial vaccine dose

  3. Serologic Protection Rate after initial vaccine

    Time frame: 30 days post booster

    Evaluate rates of serologic protection (defined as HAI titer > 40) following booster vaccine dose

  4. T cell response

    Time frame: 30 day post initial vaccine

    Measurement of CD4+/CD8+, NK cells and influenza-specific T cell

  5. T cell response

    Time frame: 30 day post booster

    Measurement of CD4+/CD8+, NK cells and influenza-specific T cell

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)

Acronym: SHIVERING

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2014
Registry last updated
Aug 25, 2016

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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