Last updated: 02/07/2025 11:10:09

RZV effectiveness and safety in patients with RA or IBD

GSK study ID
213825
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-interventional (observational) post-licensure study to assess the vaccine effectiveness and safety of recombinant zoster vaccine (RZV) in the rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) patient populations in adults 18 years of age and older
Trial description: The purpose of this observational study utilizing electronic health record (EHR) data from a large integrated health care delivery network - Kaiser Permanente Southern California (KPSC) - is to evaluate the effectiveness and safety of RZV in preventing herpes zoster (HZ) in adults greater than or equal to (≥) 18 years of age with RA or IBD (ulcerative colitis [UC] or Crohn’s disease [CD]).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of incident HZ cases in participants with RA

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (4 weeks to 6 months apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with RA

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (4 weeks to 6 months apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with IBD

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (4 weeks to 6 months apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with IBD

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (4 weeks to 6 months apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident RA flare cases

Timeframe: Within 30 days following any RZV vaccination

Number of incident IBD flare cases

Timeframe: Within 30 days following any RZV vaccination

Secondary outcomes:

Number of incident HZ cases in participants with IBD, stratified by condition (UC and CD)

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with IBD, stratified by condition (UC and CD)

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with RA, stratified by age (18-49 years and ≥50 years [≥50 years, 50-59 years, 60-69 years, and ≥70 years])

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with RA, stratified by age (18-49 years and ≥50 years [≥50 years, 50-59 years, 60-69 years, and ≥70 years])

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with IBD, stratified by age (18-49 years and ≥50 years [≥50 years, 50-59 years, 60-69 years, and ≥70 years])

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with IBD, stratified by age (18-49 years and ≥50 years [≥50 years, 50-59 years, 60-69 years, and ≥70 years])

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with RA or IBD, stratified by condition

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (Dose 2 administered >6 months after Dose 1)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with RA or IBD, stratified by condition

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (Dose 2 administered >6 months after Dose 1)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with RA or IBD, stratified by condition

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Incidence rate of HZ in participants with RA or IBD, stratified by condition

Timeframe: From 31 days after the index date [receipt of RZV Dose 2 (at least 4 weeks apart)] until occurrence of HZ, termination of membership, death, receipt of a dose of Zoster vaccine, or end of the study period, whichever comes first

Number of incident HZ cases in participants with RA who receive 1 dose of RZV and do not receive a second dose within 6 months

Timeframe: From 31 days after RZV Dose 1 until occurrence of HZ, termination of membership, receipt of: RZV Dose 1 for unvaccinated individuals, RZV Dose 2 >6 months after Dose 1 for vaccinated individuals, ZVL, or end of study period, whichever comes first

Incidence rate of HZ in participants with RA who receive 1 dose of RZV and do not receive a second dose within 6 months

Timeframe: From 31 days after RZV Dose 1 until occurrence of HZ, termination of membership, receipt of: RZV Dose 1 for unvaccinated individuals, RZV Dose 2 >6 months after Dose 1 for vaccinated individuals, ZVL, or end of study period, whichever comes first

Number of incident HZ cases in participants with IBD who receive 1 dose of RZV and do not receive a second dose within 6 months

Timeframe: From 31 days after RZV Dose 1 until occurrence of HZ, termination of membership, receipt of: RZV Dose 1 for unvaccinated individuals, RZV Dose 2 >6 months after Dose 1 for vaccinated individuals, ZVL, or end of study period, whichever comes first

Incidence rate of HZ in participants with IBD who receive 1 dose of RZV and do not receive a second dose within 6 months

Timeframe: From 31 days after RZV Dose 1 until occurrence of HZ, termination of membership, receipt of: RZV Dose 1 for unvaccinated individuals, RZV Dose 2 >6 months after Dose 1 for vaccinated individuals, ZVL, or end of study period, whichever comes first

Number of incident IBD flare cases, stratified by condition (UC and CD)

Timeframe: Within 30 days following any RZV vaccination

Interventions:
Not applicable
Enrollment:
21500
Primary completion date:
2025-30-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Kaiser Permanente of Southern California (KPSC), United States
Study date(s)
July 2022 to June 2025
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Individuals with at least 2 health care encounters with assigned ICD-10 codes for RA or IBD (UC or CD) in the year prior to and including the index date will be identified from the EHR, as specified below. This algorithm was selected based on the literature and KPSC chart review indicated a high positive predictive value of this approach.
  • Rheumatoid arthritis ICD-10 Codes
  • For both VE and safety objectives, individuals who receive a second dose less than 4 weeks (i.e., 28 days) after the first dose will be excluded, since Advisory Committee on Immunization Practices (ACIP) guidelines state that these individuals must repeat the second dose.
  • For the VE objectives, individuals with an HZ diagnosis in the 6 months prior to the index date will be excluded to ensure that HZ diagnoses after the index date are new, rather than carried over from HZ episodes prior to the index date.
Inclusion and exclusion criteria
Inclusion criteria:

    Individuals with at least 2 health care encounters with assigned ICD-10 codes for RA or IBD (UC or CD) in the year prior to and including the index date will be identified from the EHR, as specified below. This algorithm was selected based on the literature and KPSC chart review indicated a high positive predictive value of this approach. Rheumatoid arthritis ICD-10 Codes

    • M05.*

    Rheumatoid arthritis with rheumatoid factor

    • M06.*

    Other rheumatoid arthritis Crohn’s disease ICD-10 Codes

    • K50.*

    Crohn's disease Ulcerative colitis ICD-10 Codes

    • K51.*

    Ulcerative colitis Individuals will be included in the study if they meet the following criteria: VE

    • Aged ≥18 years at index date
    • At least 1-year of continuous KPSC membership prior to the index date and until 31 days after index date (allowing for a 31-day gap in membership) Safety
    • Received ≥1 dose of RZV
    • Aged ≥18 years at date of first RZV dose
    • At least 1-year continuous KPSC membership prior to date of first RZV dose (allowing for a 31 day gap in membership)
Exclusion criteria:

    For both VE and safety objectives, individuals who receive a second dose less than 4 weeks (i.e., 28 days) after the first dose will be excluded, since Advisory Committee on Immunization Practices (ACIP) guidelines state that these individuals must repeat the second dose.

    • For the VE objectives, individuals with an HZ diagnosis in the 6 months prior to the index date will be excluded to ensure that HZ diagnoses after the index date are new, rather than carried over from HZ episodes prior to the index date.
    • Individuals with HZ occurring within 30 days after the index date for both vaccinated and unvaccinated groups will also be excluded since it is unclear if the HZ episode began before or after the index date and whether the length of time since vaccination (for RZV vaccinated individuals) is long enough to allow for sufficient development of immunity.
    • Individuals with receipt of zoster vaccine within 30 days after index date will be excluded.
    • Individuals with a death date within 30 days after index date will be excluded.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)

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

Results overview

No study documents available

Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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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