InfluenzaPhase 1SHIVERINGNCT02267733
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients
A Phase 1 study testing Fluzone in people with Influenza and Gammopathy, run by Yale University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Gammopathy
- What is being tested?
- Fluzone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)
A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
Read the detailed 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.
- Conditions
- Influenza, Gammopathy
- Being tested
- Fluzone
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoneDrug
Also called Fluzone High Dose
Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration
| Study group | Role | What they receive |
|---|---|---|
| Early Disease | Experimental | Patients not requiring anti-tumor therapy Receives: Drug: Fluzone |
| Disease Requiring Anti-tumor therapy | Experimental | Patients that have disease requiring anti-tumor therapy at any time Receives: Drug: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Disease Control
Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria
Measured: up to 10 months
Secondary outcomes (5)
Influenza related morbidity rate
Measure the rate of influenza related morbidity at the end of the flu season
Measured: up to 10 months
Serologic Protection Rate after initial vaccine
Evaluate rates of serologic protection (defined as HAI titer > 40) following initial vaccine dose
Measured: 30 days post vaccine
Serologic Protection Rate after initial vaccine
Evaluate rates of serologic protection (defined as HAI titer > 40) following booster vaccine dose
Measured: 30 days post booster
T cell response
Measurement of CD4+/CD8+, NK cells and influenza-specific T cell
Measured: 30 day post initial vaccine
T cell response
Measurement of CD4+/CD8+, NK cells and influenza-specific T cell
Measured: 30 day post booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Branagan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267733
- Sponsor's protocol ID
- 1406014244
- Acronym
- SHIVERING
- Status last verified
- Aug 2016
- First submitted
- 13 Oct 2014
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)
- ClinicalTrials.gov ID
- NCT02267733
- Acronym / sponsor ID
- SHIVERING / 1406014244
- Conditions
- Influenza, Gammopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Disease | Experimental | Drug: FluzonePatients not requiring anti-tumor therapy |
| Disease Requiring Anti-tumor therapy | Experimental | Drug: FluzonePatients that have disease requiring anti-tumor therapy at any time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluzoneAlso: Fluzone High DoseFluzone High-Dose will be administered with a planned booster at 30 days post initial administration | Drug | Disease Requiring Anti-tumor therapy, Early Disease |
Primary outcome
Rate of Disease Control
Time frame: up to 10 months
Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria
5 secondary outcomes
Influenza related morbidity rate
Time frame: up to 10 months
Serologic Protection Rate after initial vaccine
Time frame: 30 days post vaccine
Serologic Protection Rate after initial vaccine
Time frame: 30 days post booster
T cell response
Time frame: 30 day post initial vaccine
T cell response
Time frame: 30 day post booster
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Branagan, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluzone in people with Influenza and Gammopathy, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Disease Control (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.