NCT02936180

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

October 7, 2016

Results QC Date

September 1, 2021

Last Update Submit

August 12, 2024

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisFlu vaccineInfluenza

Outcome Measures

Primary Outcomes (3)

  • 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.

    Day 28

  • 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.

    Day 28

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

    Geometric mean titres (GMTs) of HI at D28.

    Day 28

Secondary Outcomes (2)

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

    Day 186

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

    Day 28

Other Outcomes (2)

  • Performance of the Micro-neutralization Assay in Comparison to the HI Assay.

    Day 186

  • Rates of Health Care Use in Patients Receiving SD- or HD-IV.

    Day 186

Study Arms (2)

Standard dose influenza vaccine

ACTIVE COMPARATOR

Patients will receive one dose of FLUZONE® Standard Dose Quadrivalent Inactivated Influenza Vaccine (SD-QIV)

Biological: SD-QIV

High dose influenza vaccine

ACTIVE COMPARATOR

Patients will receive one dose of FLUZONE® High Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)

Biological: HD-TIV

Interventions

HD-TIVBIOLOGICAL
High dose influenza vaccine
SD-QIVBIOLOGICAL
Standard dose influenza vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38258270RESULT

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidInfluenza, Human

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Ines Colmegna, MD
Organization
McGill University
ines.colmegna@mcgill.ca
514-934-1934

Study Officials

  • Ines Colmegna, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)