Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bassett Healthcare
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Initial Immune response
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Donald A Raddatz
Attending Physician, Department of Medicine - Rheumatology
Bassett Healthcare
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
Outcomes
Primary Outcomes
Initial Immune response
Time Frame: 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
Time Frame: 6 months post vaccination
proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period
Secondary Outcomes
- Occurrence of influenza infection(6 months post vaccination)
- Occurrence of flu-like illnesses(6 months post vaccination)