Duration of Immune Response to Influenza Vaccination in Patients With RA
|ClinicalTrials.gov Identifier: NCT02311855|
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Influenza vaccine||Phase 4|
- 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 (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|
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.
- 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;
- 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
- Occurrence of influenza infection [ Time Frame: 6 months post vaccination ]proportion of patients who are diagnosed with confirmed influenza despite vaccination
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311855
|United States, New York|
|Bassett Healthcare Network|
|Cooperstown, New York, United States, 13326|
|Principal Investigator:||Donald Raddatz, MD||Bassett Healthcare|