Standard Versus High Dose Inactivated Influenza Vaccine in RA (IV-RA)
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|ClinicalTrials.gov Identifier: NCT02936180|
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Influenza, a vaccine-preventable respiratory disease, is ranked 8th among the causes of death in the Canadian population. Among rheumatoid arthritis (RA) patients, the incidence of both seasonal influenza and serious influenza-related illness (IRI) are increased. Despite being a high priority group targeted for vaccination, the diagnosis of RA and other patient-specific factors (i.e. older age, treatment, current smoking) are linked to impaired vaccination responses.
Thus the burden of influenza among people with RA is disproportionally high, and interventions to improve responses to influenza vaccination are urgently needed. Strategies to optimize protection in another vulnerable group, the elderly, include the use of quadrivalent vaccines, higher antigen doses, and adjuvants. A high-dose, trivalent, inactivated influenza vaccine (HD-TIV) has recently been shown to have a similar safety profile to standard dose vaccine (SD-TIV) with improved immunogenicity and protection in adults ≥65 years of age. Whether or not analogous strategies to improve responses to influenza vaccine will enhance protection in people with RA is unknown. The investigators hypothesize that the use of the HD-influenza vaccine will improve vaccine-induced protection (i.e. seroconversion and seroprotection) in people with RA compared to SD-influenza vaccine. The investigators propose to conduct a stratified, randomized, modified double blind, active-controlled trial to assess immune responses to two commercial influenza vaccines containing different antigen doses in individuals with RA.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: HD-TIV Biological: SD-QIV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||407 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: Standard dose influenza vaccine
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
Active Comparator: High dose influenza vaccine
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
- Seroconversion rate to HD- versus SD-IV in people with RA [ Time Frame: Day 28 ]Seroconversion rate (SCR): proportion of subjects in a given treatment group (SD- or HD) with either a ≥4-fold increase in reciprocal HI titres between D0 and D28 or a rise of undetectable HI titre (i.e. <1:10) pre-vaccination (D0) to an HI titre of ≥1:40 at D28 post vaccination.
- Seroprotection rate to HD- versus SD-IV in people with RA [ Time Frame: Day 28 ]Seroprotection rate (SPR): the proportion of subjects in a given treatment group attaining a reciprocal HI titre of ≥1:40 at D28 post-vaccination.
- Seroconversion factor in people with RA who received HD- versus SD-IV [ Time Frame: Day 28 ]Seroconversion factor or GMFR: the geometric mean of the ratio of GMTs (D28/ D0).
- Geometric mean titres (GMTs) of HI in people with RA who received HD- versus SD-IV [ Time Frame: Day 0 and Day 28 ]Geometric mean titres (GMTs) of HI at D0 and D28.
- Durability of HI antibody responses for SD- and HD- IV. [ Time Frame: Day 186 ]
- Rates of side effects during the surveillance period in SD- and HD-IV. [ Time Frame: Day 28 ]
- Performance of the micro-neutralization assay in comparison to the HI assay. [ Time Frame: Day 186 ]
- Rates of health care use in patients receiving SD- or HD-IV. [ Time Frame: Day 186 ]
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): NCT02936180
|McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|