Duration of Immune Response to Influenza Vaccination in Patients With RA

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311855
• Other study ID #: 1076
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2014
• Last updated: January 5, 2017
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2017
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Bassett Healthcare Network	Cooperstown	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bassett Healthcare	New York State Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Occurrence of influenza infection	proportion of patients who are diagnosed with confirmed influenza despite vaccination	6 months post vaccination	No
Secondary	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	Yes