Brief Title
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
Official Title
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING 2)
Brief 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
Detailed 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Treatment Failure by Primary Endpoint
Condition
Influenza
Intervention
Fluzone High Dose Vaccine
Study Arms / Comparison Groups
Fluzone High Dose Vaccine then Fluzone High Dose Booster
Description: Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
122
Start Date
September 2015
Completion Date
June 2018
Primary Completion Date
October 2017
Eligibility Criteria
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
Waldenstrӧm 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.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Andrew Branagan, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02566265
Organization ID
1507016111
Responsible Party
Sponsor
Study Sponsor
Yale University
Study Sponsor
Andrew Branagan, MD, Principal Investigator, Yale University
Verification Date
January 2019