Duration of Immune Response to Influenza Vaccination in Patients With RA

Phase 4

Completed

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

Recruitment & Eligibility

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):

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)

Arm && Interventions

Group	Intervention	Description
Influenza vaccination	Influenza vaccine	all patients are vaccinated per protocol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Locations (1): Bassett Healthcare Network
🇺🇸
Cooperstown, New York, United States

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