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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
Sponsor:
Collaborator:
The Arthritis Society, Canada
Information provided by (Responsible Party):
Ines Colmegna, McGill University Health Center

Brief 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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard dose influenza vaccine
Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
Biological: SD-QIV
Active Comparator: High dose influenza vaccine
Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
Biological: HD-TIV



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.


Secondary Outcome Measures :
  1. Durability of HI antibody responses for SD- and HD- IV. [ Time Frame: Day 186 ]
  2. Rates of side effects during the surveillance period in SD- and HD-IV. [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. Performance of the micro-neutralization assay in comparison to the HI assay. [ Time Frame: Day 186 ]
  2. Rates of health care use in patients receiving SD- or HD-IV. [ Time Frame: Day 186 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Center
The Arthritis Society, Canada

Responsible Party: Ines Colmegna, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02936180     History of Changes
Other Study ID Numbers: MP-37-2017-2773
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ines Colmegna, McGill University Health Center:
Rheumatoid arthritis
Flu vaccine
Influenza

Additional relevant MeSH terms:
Arthritis
Influenza, Human
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs