Duration of Immune Response to Influenza Vaccination in Patients With RA



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 75
Updated:1/7/2017
Start Date:August 2014
End Date:February 2016

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Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents

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.

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

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)
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