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NCT Number: NCT02311855

Duration of Immune Response to Influenza Vaccination in Patients With RA

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

influenza vaccine

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.

Other names: Fluzone, Fluzone High Dose

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Bassett Healthcare

Other

Collaborators

  • New York State Department of Health

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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