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Rheumatoid ArthritisPhase 4IV-RANCT02936180

Standard Versus High Dose Inactivated Influenza Vaccine in RA

A Phase 4 study testing HD-TIV and SD-QIV in people with Rheumatoid Arthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
HD-TIV and SD-QIV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
1 siteCanada
Study dates
Oct 2016to Dec 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

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?

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).

Read the detailed description

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.

Being tested
HD-TIV, SD-QIV
Keywords
Rheumatoid arthritis, Flu vaccine, Influenza
Medical subject headings
Arthritis, Rheumatoid, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HD-TIVBiological

  • SD-QIVBiological

Study groups in NCT02936180
Study groupRoleWhat they receive
Standard dose influenza vaccineActive comparatorPatients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)
Receives: Biological: SD-QIV
High dose influenza vaccineActive comparatorPatients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
Receives: Biological: HD-TIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion Rate to HD- Versus SD-IV in People With RA

    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.

    Measured: Day 28

  2. Seroprotection Rate to HD- Versus SD-IV in People With RA

    Seroprotection rate (SPR): the proportion of subjects in a given treatment group attaining a reciprocal HI titre of ≥1:40 at D28 post-vaccination.

    Measured: Day 28

  3. Geometric Mean Titres (GMTs) of HI in People With RA Who Received HD- Versus SD-IV

    Geometric mean titres (GMTs) of HI at D28.

    Measured: Day 28

Secondary outcomes (2)

  1. Durability of Detectable Levels of HI Antibody for SD- and HD- IV.

    Number of participants with detectable HI antibodies at Day 186

    Measured: Day 186

  2. Rates of Side Effects During the Surveillance Period in SD- and HD-IV.

    Number of Participants with Side Effects

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJul 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02936180
Sponsor's protocol ID
MP-37-2017-2773
Acronym
IV-RA
Status last verified
Aug 2024
First submitted
7 Oct 2016
Last updated
13 Aug 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Colmegna I, Useche ML, Rodriguez K, McCormack D, Alfonso G, Patel A, Ramanakumar AV, Rahme E, Bernatsky S, Hudson M, Ward BJ. Immunogenicity and safety of high-dose versus standard-dose inactivated influenza vaccine in rheumatoid arthritis patients: a randomised, double-blind, active-comparator trial. Lancet Rheumatol. 2020 Jan;2(1):e14-e23. doi: 10.1016/S2665-9913(19)30094-3. Epub 2019 Nov 20.

    PubMed 38258270

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HD-TIV and SD-QIV in people with Rheumatoid Arthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion Rate to HD- Versus SD-IV in People With RA (time frame: Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02936180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

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