Rheumatoid Arthritis
Conditions
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
Interventions
BIOLOGICALInfluenza vaccine
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.
Sponsors
New York State Department of Health
Bassett Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Immune response | 4-6 weeks post vaccination | 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 | 6 months post vaccination | proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of influenza infection | 6 months post vaccination | proportion of patients who are diagnosed with confirmed influenza despite vaccination |
| Occurrence of flu-like illnesses | 6 months post vaccination | 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). |
Countries
United States
Outcome results
None listed