Last updated: 12/12/2024 14:30:09

A matched cohort study to evaluate RZV effectiveness in U.S. patients with autoimmune diseases

GSK study ID
219111
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A retrospective matched cohort database study in the United States to evaluate the effectiveness of recombinant zoster vaccine (RZV) in patients with autoimmune diseases (AIDs)
Trial description: The purpose of the current retrospective matched cohort database study was to provide early real-world evidence of the effectiveness of Recombinant zoster vaccine (RZV) in patients aged 50 years of age (YOA) and older with autoimmune diseases (AIDs) in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

VE against HZ after 2 doses of RZV in participants ≥50 YOA with systemic lupus erythematosus (SLE)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with multiple sclerosis (MS)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with rheumatoid arthritis (RA)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with inflammatory bowel disease (IBD)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with psoriasis (PsO)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with psoriatic arthritis (PsA)

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

Secondary outcomes:

VE against HZ after 2 doses of RZV in participants ≥50 YOA with IBD stratified by condition (ulcerative colitis [UC], Crohn’s disease [CD])

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with either PsO or PsA

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with SLE stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with MS stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with RA stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with IBD stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with PsO stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with PsA stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 2 doses of RZV in participants ≥50 YOA with either PsO or PsA stratified by age, gender, time since vaccination, time interval between two doses, and medication category based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with SLE

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with MS

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with RA

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with IBD stratified by condition (UC and CD)

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with PsO

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with PsA

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

VE against HZ after 1 dose of RZV in participants ≥50 YOA with either PsO or PsA

Timeframe: From index date (receipt of RZV first dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of RZV second dose, receipt of ZVL, or 31/12/2021 (end of study period)

Overall VE against HZ after 2 doses of RZV in participants ≥50 YOA with selected AIDs by age, gender, time since vaccination, time interval between two doses, and medication category (mutually exclusive) based on current use at the index date

Timeframe: From index date (receipt of RZV second dose) until the occurrence of HZ, termination of membership, death, receipt of RZV first dose for unvaccinated participants, receipt of ZVL, or 31/12/2021 (end of study period)

Interventions:
Not applicable
Enrollment:
42755
Primary completion date:
2023-15-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Autoimmune Diseases
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
October 2022 to December 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
  • Age >50 YOA at the index date for all study objectives and registered as beneficiary in the Optum™ database.
  • Meet criteria for RA, IBD, SLE, MS, PsO or PsA prior to the index date.
  • Any previous RZV doses before index date (for unvaccinated participants only) using all available data.
  • Receipt of second dose of RZV less than 28 days apart since Advisory Committee on Immunization Practices (ACIP) guidelines state that these participants must repeat the second dose.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2023-15-12
Actual study completion date
2023-15-12

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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