Duration of Immune Response to Influenza Vaccination in Patients With RA
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria (RA Patients)
- Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
- Age 40-75
Inclusion Criteria (Healthy Controls):
- Age 40-75
Exclusion Criteria:
Exclusion criteria (RA Patients)
- Known hypersensitivity/allergy influenza vaccine
- Chronic debilitating conditions (such as end-stage Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), liver disease, Chronic Kidney Disease (CKD) )
- Active malignancy at time of vaccination
- Pregnancy and lactation
- Known HIV
- Active infection at time of vaccination
- Recent acute illness (within 1 month prior to vaccination)
Exclusion Criteria(Healthy Controls):
- Known autoimmune conditions
- Chronic use of immunosuppressant treatments
- Known hypersensitivity/allergy influenza vaccine
- Chronic debilitating conditions (such as end-stage COPD, CHF, liver disease, CKD)
- Active malignancy at time of vaccination
- Pregnancy and lactation
- Known HIV
- Active infection at time of vaccination
- Recent acute illness (within 1 month prior to vaccination)
Sites / Locations
- Bassett Healthcare Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Influenza vaccination
Arm Description
all patients are vaccinated per protocol
Outcomes
Primary Outcome Measures
Initial Immune response
proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;
Total proportion of seroconversion
proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period
Secondary Outcome Measures
Occurrence of influenza infection
proportion of patients who are diagnosed with confirmed influenza despite vaccination
Occurrence of flu-like illnesses
proportion of patient who developed influenza-like symptoms (defined as two or more of the following: cough, myalgias, fever, arthralgias, throat pain, headache, nasal congestion).
Full Information
NCT ID
NCT02311855
First Posted
December 4, 2014
Last Updated
January 5, 2017
Sponsor
Bassett Healthcare
Collaborators
New York State Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT02311855
Brief Title
Duration of Immune Response to Influenza Vaccination in Patients With RA
Official Title
Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bassett Healthcare
Collaborators
New York State Department of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective is to evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents as compared to a group healthy controls who do not have RA. Influenza vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the baseline visit after the baseline blood draw.
Detailed Description
Aims:
Evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents.
Evaluate for predictors of immune response such as age, gender, disease duration, type of the biological agent(s) used, duration of the treatment, and type of treatment in the past.
Assess the efficacy of vaccine response in this population by recording proportion of patients who contracted influenza illness despite vaccination. The result of the study may provide more information regarding which situations inadequate immune response by strength or duration would most likely to be expected. This may help lay some groundwork for future studies looking at the use of booster vaccinations in this population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccination
Arm Type
Other
Arm Description
all patients are vaccinated per protocol
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Other Intervention Name(s)
Fluzone, Fluzone High Dose
Intervention Description
Each participant will have a blood draw to measure the antibody titres influenza strains covered by the 2014-2015 influenza vaccine at three different time points:
Visit 1- Baseline/prior to vaccination Visit 2- 4-6 weeks post-vaccination Visit 3- end of influenza season (April-May)
At Visit 1, after the baseline blood draw, all participants will be vaccinated by Research staff in order to standardize the time from Baseline blood draw to vaccination. Participants aged 65 and older will be offered the extra strength version of the vaccine, which is usual care. Participants under the age of 65 will be given the usual strength vaccine. All patients will be given the intramuscular (IM) vaccine.
Primary Outcome Measure Information:
Title
Initial Immune response
Description
proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;
Time Frame
4-6 weeks post vaccination
Title
Total proportion of seroconversion
Description
proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period
Time Frame
6 months post vaccination
Secondary Outcome Measure Information:
Title
Occurrence of influenza infection
Description
proportion of patients who are diagnosed with confirmed influenza despite vaccination
Time Frame
6 months post vaccination
Title
Occurrence of flu-like illnesses
Description
proportion of patient who developed influenza-like symptoms (defined as two or more of the following: cough, myalgias, fever, arthralgias, throat pain, headache, nasal congestion).
Time Frame
6 months post vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria (RA Patients)
Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
Age 40-75
Inclusion Criteria (Healthy Controls):
Age 40-75
Exclusion Criteria:
Exclusion criteria (RA Patients)
Known hypersensitivity/allergy influenza vaccine
Chronic debilitating conditions (such as end-stage Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), liver disease, Chronic Kidney Disease (CKD) )
Active malignancy at time of vaccination
Pregnancy and lactation
Known HIV
Active infection at time of vaccination
Recent acute illness (within 1 month prior to vaccination)
Exclusion Criteria(Healthy Controls):
Known autoimmune conditions
Chronic use of immunosuppressant treatments
Known hypersensitivity/allergy influenza vaccine
Chronic debilitating conditions (such as end-stage COPD, CHF, liver disease, CKD)
Active malignancy at time of vaccination
Pregnancy and lactation
Known HIV
Active infection at time of vaccination
Recent acute illness (within 1 month prior to vaccination)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Raddatz, MD
Organizational Affiliation
Bassett Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassett Healthcare Network
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Duration of Immune Response to Influenza Vaccination in Patients With RA
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