Last updated: 10/19/2023 12:40:32

Study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged ≥18 years with psoriasis or psoriatic arthritis

GSK study ID
216976
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
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 effectiveness and safety of recombinant zoster vaccine in adults aged ≥18 years with psoriasis or psoriatic arthritis
Trial description: The purpose of this observational study is to evaluate the vaccine effectiveness (prevention of herpes zoster [HZ]) and safety (risk of flares) of recombinant zoster vaccine (RZV) among adults (≥) 18 years of age (YOA) or older, with psoriasis (PsO) or psoriatic arthritis (PsA) at Kaiser Permanente Southern California (KPSC), United States.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Vaccine effectiveness in preventing Herpes Zoster (HZ) in Southern California participants with psoriasis (PsO), who receive 2 doses of recombinant zoster vaccine (RZV)

Timeframe: From Day 31 after the index date (RZV Dose 2) until the end of study follow-up, occurrence of outcome of interest, or occurrence of a censoring event (death, termination of KPSC membership, or receipt of an RZV dose), whichever comes first

Rate of flares in Southern California participants with psoriasis (PsO)

Timeframe: Within 30 days following RZV vaccination as compared to the rate in self-controlled comparison periods

Secondary outcomes:

Vaccine effectiveness in preventing Herpes Zoster (HZ) in Southern California participants with psoriasis (PsO) or psoriatic arthritis (PsA), who receive 2 doses of recombinant zoster vaccine (RZV)

Timeframe: From Day 31 after the index date (RZV Dose 2) until the end of study follow-up, occurrence of outcome of interest, or occurrence of a censoring event (death, termination of KPSC membership, or receipt of an RZV dose), whichever comes first

Vaccine effectiveness in preventing Herpes Zoster (HZ) in Southern California participants with psoriatic arthritis (PsA), who receive 2 doses of recombinant zoster vaccine (RZV)

Timeframe: From Day 31 after the index date (RZV Dose 2) until the end of study follow-up, occurrence of outcome of interest, or occurrence of a censoring event (death, termination of KPSC membership, or receipt of an RZV dose), whichever comes first

Vaccine effectiveness in preventing Herpes Zoster (HZ) in Southern California participants with psoriasis (PsO), who receive 1 dose of recombinant zoster vaccine (RZV) and do not receive a second dose within 6 months after the first dose

Timeframe: From Day 31 after the index date (RZV Dose 1) until occurrence of HZ, termination of membership, receipt of an RZV dose for unvaccinated individuals or an RZV Dose 2 >6 months after Dose 1 for vaccinated ones, end of study period, whichever comes first

Vaccine effectiveness in preventing Herpes Zoster (HZ) in Southern California participants with psoriatic arthritis (PsA), who receive 1 dose of recombinant zoster vaccine (RZV) and do not receive a second dose within 6 months after the first dose

Timeframe: From Day 31 after the index date (RZV Dose 1) until occurrence of HZ, termination of membership, receipt of an RZV dose for unvaccinated individuals or an RZV Dose 2 >6 months after Dose 1 for vaccinated ones, end of study period, whichever comes first

Baseline characteristics of individuals vaccinated with 2 doses of RZV compared to their unvaccinated matches in Southern California participants with psoriasis (PsO)

Timeframe: At baseline

Baseline characteristics of individuals vaccinated with 2 doses of RZV compared to their unvaccinated matches in Southern California participants with psoriatic arthritis (PsA)

Timeframe: At baseline

Rate of flares in Southern California participants with psoriasis (PsO) or psoriatic arthritis (PsA)

Timeframe: Within 30 days following RZV vaccination as compared to the rate in self-controlled comparison periods

Rate of flares in Southern California participants with psoriatic arthritis (PsA)

Timeframe: Within 30 days following RZV vaccination as compared to the rate in self-controlled comparison periods

Interventions:
Not applicable
Enrollment:
12802
Primary completion date:
2023-12-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Kaiser Permanente Southern California (KPSC)
Study date(s)
November 2023 to December 2026
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Vaccine Effectiveness objectives
  • Aged ≥18 years at index date.
  • Vaccine Effectiveness 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:

    Vaccine Effectiveness objectives

    • Aged ≥18 years at index date.
    • ≥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).
    • Meet criteria for PsO or PsA in the year prior to and including the index date. Safety objectives
    • Received ≥1 dose of RZV during the accrual period.
    • Aged ≥18 years at index date (date of first RZV dose).
    • ≥1-year continuous KPSC membership prior to and including index date (allowing for a 31-day gap in membership).
    • Meet criteria for PsO or PsA in the year prior to and including the index date.
Exclusion criteria:

    Vaccine Effectiveness 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 on or 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 who receive RZV vaccine within 30 days after the index date or die during the 30 days after the index date will also be excluded to prevent individuals from being censored before follow-up begins. Safety objectives
    • Individuals who receive a second RZV dose <4 weeks (28 days) after the first dose will be excluded, since ACIP guidelines state that these individuals must repeat the second dose.

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
Will be recruiting
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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