Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Duration of Immune Response to Influenza Vaccination in Patients With RA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311855
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
Donald A Raddatz, Bassett Healthcare

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Influenza vaccine Phase 4

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
  • Fluzone High Dose




Primary Outcome Measures :
  1. Initial Immune response [ Time Frame: 4-6 weeks post vaccination ]
    proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;

  2. Total proportion of seroconversion [ Time Frame: 6 months post vaccination ]
    proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period


Secondary Outcome Measures :
  1. Occurrence of influenza infection [ Time Frame: 6 months post vaccination ]
    proportion of patients who are diagnosed with confirmed influenza despite vaccination

  2. Occurrence of flu-like illnesses [ Time Frame: 6 months post vaccination ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311855


Locations
Layout table for location information
United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Sponsors and Collaborators
Bassett Healthcare
New York State Department of Health
Investigators
Layout table for investigator information
Principal Investigator: Donald Raddatz, MD Bassett Healthcare

Layout table for additonal information
Responsible Party: Donald A Raddatz, Attending Physician, Department of Medicine - Rheumatology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02311855     History of Changes
Other Study ID Numbers: 1076
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs