Duration of Immune Response to Influenza Vaccination in Patients With RA

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Influenza vaccine

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

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Influenza vaccination; all patients are vaccinated per protocol

Biological: Influenza vaccine; Each participant will have a blood draw to measure the antibody titres influenza strains covered by the 2014-2015 influenza vaccine at three different time points: Visit 1- Baseline/prior to vaccination Visit 2- 4-6 weeks post-vaccination Visit 3- end of influenza season (April-May) At Visit 1, after the baseline blood draw, all participants will be vaccinated by Research staff in order to standardize the time from Baseline blood draw to vaccination. Participants aged 65 and older will be offered the extra strength version of the vaccine, which is usual care. Participants under the age of 65 will be given the usual strength vaccine. All patients will be given the intramuscular (IM) vaccine.; Other Names: Fluzone High Dose; Fluzone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Immune response	proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;	4-6 weeks post vaccination
Total proportion of seroconversion	proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period	6 months post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of influenza infection	proportion of patients who are diagnosed with confirmed influenza despite vaccination	6 months post vaccination
Occurrence of flu-like illnesses	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).	6 months post vaccination

Collaborators and Investigators

• Sponsor: Bassett Healthcare
• Collaborators: New York State Department of Health
• Investigators: Principal Investigator: Donald Raddatz, MD, Bassett Healthcare

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 1076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO