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

Influenza Clinical Trial

— SHIVERING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267733
• Other study ID #: 1406014244
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2014
• Last updated: August 24, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gammopathy
• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Disease Control	Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria	up to 10 months	No
Secondary	Influenza related morbidity rate	Measure the rate of influenza related morbidity at the end of the flu season	up to 10 months	No
Secondary	Serologic Protection Rate after initial vaccine	Evaluate rates of serologic protection (defined as HAI titer > 40) following initial vaccine dose	30 days post vaccine	No
Secondary	Serologic Protection Rate after initial vaccine	Evaluate rates of serologic protection (defined as HAI titer > 40) following booster vaccine dose	30 days post booster	No
Secondary	T cell response	Measurement of CD4+/CD8+, NK cells and influenza-specific T cell	30 day post initial vaccine	No
Secondary	T cell response	Measurement of CD4+/CD8+, NK cells and influenza-specific T cell	30 day post booster	No