Duration of Immune Response to Influenza Vaccination in Patients With RA

NCT ID: NCT02311855

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-02-29

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Influenza vaccination

all patients are vaccinated per protocol

Group Type: OTHER

Influenza vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone; Fluzone High Dose

Eligibility Criteria

Inclusion Criteria

• Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
• Age 40-75

• Age 40-75

Exclusion Criteria

• 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)

• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Department of Health

OTHER_GOV

Sponsor Role: collaborator

Bassett Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Donald A Raddatz

Attending Physician, Department of Medicine - Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Raddatz, MD

Role: PRINCIPAL_INVESTIGATOR

Bassett Healthcare

Locations

Bassett Healthcare Network

Cooperstown, New York, United States

Countries

United States

Other Identifiers

1076

Identifier Type: -

Identifier Source: org_study_id