Phase 4
N=279
Standard Versus High Dose Inactivated Influenza Vaccine in RA
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02936180 ↗Enrolled (actual)
279
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Seroconversion Rate to HD- Versus SD-IV in People With RA — 12; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HD-TIV (Biological); SD-QIV (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate to HD- Versus SD-IV in People With RA |
12; 31 | — |
| PRIMARY Seroprotection Rate to HD- Versus SD-IV in People With RA |
42; 67 | — |
| PRIMARY Geometric Mean Titres (GMTs) of HI in People With RA Who Received HD- Versus SD-IV |
1.56; 2.06 | — |
| SECONDARY Durability of Detectable Levels of HI Antibody for SD- and HD- IV. |
29; 43 | — |
| SECONDARY Rates of Side Effects During the Surveillance Period in SD- and HD-IV. |
19; 20 | — |
Summary
Patients with rheumatoid arthritis have increased risk of seasonal influenza and influenza-related complications but have reduced vaccine immunogenicity. It is unknown whether patients with rheumatoid arthritis would benefit from more immunogenic vaccine formulations. This study investigated the immunogenicity and safety of a high-dose trivalent inactivated influenza vaccine (HD-TIV) in patients with rheumatoid arthritis compared to a standard-dose quadrivalent influenza vaccine (SD-QIV).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of seropositive RA (rheumatoid factor (RF) and/or anti-CCP antibody positive) based on the 2010 ACR-EULAR criteria.
- At least 6 months of treatment including anti-TNF agents, abatacept, rituximab (dose received within the previous 6 months) and/or methotrexate.
- Informed consent form signed and dated.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- Vaccination against influenza in the 6 months preceding the trial vaccination.
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to TIV or to a vaccine containing any of the same substances.
- History of Guillain-Barré syndrome within six weeks of a previous influenza vaccination.
- Dementia or any other cognitive condition that could interfere with the trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating IM vaccination (according to treating rheumatologist).
- Current alcohol abuse or drug addiction.
- Moderate or severe acute illness with or without fever. If this exists, vaccination will be deferred until the individual has been medically stable and/or afebrile for at least 24 hours.
- Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
- Pregnant women (the rationale for excluding this group is not their lack of indication for vaccination but the changes of maternal immune responses during pregnancy)
Data sourced from ClinicalTrials.gov (NCT02936180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.