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

Multiple Myeloma Clinical Trial

— SHIVERING 2  

Official title:

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566265
• Other study ID #: 1507016111
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: June 2018

Study information

• Verified date: January 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

Description:

Influenza is a major cause of morbidity in the US. Patients with monoclonal gammopathies are known to have increased risk of developing influenza. Furthermore, several of the medications (such as proteasome inhibitors), commonly used to treat these tumors, are known to further increase the risk of these tumors. Seasonal influenza vaccination has been shown to reduce influenza related morbidity and is approved for routine prophylaxis in US. In 2009, Fluzone® high- dose vaccine was FDA approved in 2009 for adults aged 65 and older based on the data regarding higher rates of seroprotection (defined as hemagglutination antibody inhibition (HAI) titer of 40 or higher).

In this study, the investigators will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies irrespective of age versus a standard of care control group. Primary endpoint is composite of documented influenza infection rate and disease progression (as defined by International Myeloma Working Group criteria) at the end of the flu season. Based on the background data, the investigators expect a higher rate of success in the experimental arm. As such, the investigators power for success rates of 90% and 70% in the experimental and control arms, respectively.

The investigators will also analyze several secondary endpoints including rates of influenza related morbidity, the analysis of humoral and cellular immune response to these vaccines and the rate of disease control (defined as lack of disease progression by standard international myeloma working group criteria).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Understand and voluntarily sign an informed consent form.

• 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 Waldenstr?¨m Macroglobulinemia (WM).

Exclusion Criteria:

• Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.

• Use of any other influenza vaccine for the 2015 to 2016 flu season.

• Women who are pregnant or plan to become pregnant in the study period.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• MGUS
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Disorders
• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

Biological:
• Fluzone High Dose Vaccine

• Standard of care/Placebo

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	Number of Participants With Treatment Failure by Primary Endpoint	Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.	1 year