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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

Ukendt

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

280

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosis of seropositive RA (rheumatoid factor (RF) and/or anti-CCP antibody positive) based on the 2010 ACR-EULAR criteria.
  2. At least 6 months of treatment including anti-TNF agents, abatacept, rituximab (dose received within the previous 6 months) and/or methotrexate.
  3. Informed consent form signed and dated.
  4. Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  1. Vaccination against influenza in the 6 months preceding the trial vaccination.
  2. 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.
  3. History of Guillain-Barré syndrome within six weeks of a previous influenza vaccination.
  4. Dementia or any other cognitive condition that could interfere with the trial procedures.
  5. Thrombocytopenia or bleeding disorder contraindicating IM vaccination (according to treating rheumatologist).
  6. Current alcohol abuse or drug addiction.
  7. 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.
  8. Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
  9. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2016

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

7. oktober 2016

Først indsendt, der opfyldte QC-kriterier

14. oktober 2016

Først opslået (Skøn)

18. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med SD-QIV

3
Abonner