- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02936180
Standard Versus High Dose Inactivated Influenza Vaccine in RA (IV-RA)
Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Standard dose influenza vaccine
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
|
|
Aktiv komparator: High dose influenza vaccine
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Seroconversion rate to HD- versus SD-IV in people with RA
Tidsramme: 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.
|
Day 28
|
Seroprotection rate to HD- versus SD-IV in people with RA
Tidsramme: 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.
|
Day 28
|
Seroconversion factor in people with RA who received HD- versus SD-IV
Tidsramme: Day 28
|
Seroconversion factor or GMFR: the geometric mean of the ratio of GMTs (D28/ D0).
|
Day 28
|
Geometric mean titres (GMTs) of HI in people with RA who received HD- versus SD-IV
Tidsramme: Day 0 and Day 28
|
Geometric mean titres (GMTs) of HI at D0 and D28.
|
Day 0 and Day 28
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Durability of HI antibody responses for SD- and HD- IV.
Tidsramme: Day 186
|
Day 186
|
Rates of side effects during the surveillance period in SD- and HD-IV.
Tidsramme: Day 28
|
Day 28
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Performance of the micro-neutralization assay in comparison to the HI assay.
Tidsramme: Day 186
|
Day 186
|
Rates of health care use in patients receiving SD- or HD-IV.
Tidsramme: Day 186
|
Day 186
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MP-37-2017-2773
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Rheumatoid arthritis
-
Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
-
Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
-
Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
-
Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
-
Richard Burt, MDAfsluttet
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
-
Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
-
Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
-
University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
-
Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
Kliniske forsøg med SD-QIV
-
Sanofi Pasteur, a Sanofi CompanyAfsluttet
-
Tor Biering-SørensenSanofi; Statens Serum InstitutRekruttering
-
Tor Biering-SørensenSanofi Pasteur, a Sanofi CompanyAfsluttet
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Sanofi Pasteur, a Sanofi CompanySanofi K.K.Afsluttet
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Sanofi Pasteur, a Sanofi CompanyAfsluttet
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Sanofi Pasteur, a Sanofi CompanyAfsluttet
-
Butantan InstituteButantan FoundationAktiv, ikke rekrutterendeInfluenza, menneskeBrasilien
-
SeqirusAfsluttet
-
Sanofi Pasteur, a Sanofi CompanyAfsluttetInfluenza | InfluenzaKina
-
SeqirusAfsluttet