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Virus Vaccine

Standard dose influenza vaccine for Rheumatoid Arthritis (IV-RA Trial)

Phase 4
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 186
Awards & highlights

IV-RA Trial Summary

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.

Eligible Conditions
  • Rheumatoid Arthritis

IV-RA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 186
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 186 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Refractory anemias
Seroconversion factor in people with RA who received HD- versus SD-IV
Seroconversion rate to HD- versus SD-IV in people with RA
+1 more
Secondary outcome measures
Durability of HI antibody responses for SD- and HD- IV.
Rates of side effects during the surveillance period in SD- and HD-IV.
Other outcome measures
Performance of the micro-neutralization assay in comparison to the HI assay.
Rates of health care use in patients receiving SD- or HD-IV.

IV-RA Trial Design

2Treatment groups
Active Control
Group I: Standard dose influenza vaccineActive Control1 Intervention
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
Group II: High dose influenza vaccineActive Control1 Intervention
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
158,894 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
1,347 Patients Enrolled for Rheumatoid Arthritis
The Arthritis Society, CanadaOTHER
24 Previous Clinical Trials
5,342 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
1,362 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~33 spots leftby Apr 2025