Clinical trial NCT02311855: Duration of Immune Response to Influenza Vaccination in Patients With RA
Official title: Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
Collaborators: name: New York State Department of Health
First posted: 2014-12-09
Enrollment: 87
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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
* 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)

Primary outcomes:
measure: Initial Immune response
timeFrame: 4-6 weeks post vaccination
measure: Total proportion of seroconversion
timeFrame: 6 months post vaccination
Secondary outcomes:
measure: Occurrence of influenza infection
timeFrame: 6 months post vaccination
measure: Occurrence of flu-like illnesses
timeFrame: 6 months post vaccination
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Healthcare Network
state: New York
Study officials:
affiliation: Bassett Healthcare
name: Donald Raddatz, MD
role: PRINCIPAL_INVESTIGATOR
References: