Duration of Immune Response to Influenza Vaccination in Patients With RA

Bassett Healthcare

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Biological: Influenza vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02311855

1076

Details and patient eligibility

About

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.

Full 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

Enrollment

87 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)