A matched cohort study to evaluate RZV effectiveness in U.S. patients with autoimmune diseases
Trial overview
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)
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)
- 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.
- Meet criteria for RA, IBD, SLE, MS, PsO or PsA prior to the index date.
- Receipt of first dose of RZV on or after 1 January 2018.
- 365 days of continuous enrollment (allowing administrative gaps 30 days) prior to the index date (baseline period) and continuous enrollment in the 30 days after the index date.
Age >50 YOA at the index date for all study objectives and registered as beneficiary in the Optum™ database.
- 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.
- Receipt of ZVL any time during the baseline as this may affect rates of HZ.
- HZ diagnosis or prescription fills for oral acyclovir, valacyclovir or famciclovir given specifically for HZ and within 30 days of index date 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 participants) is long enough to allow for sufficient development of immunity.
- HZ diagnosis or prescription fills for oral acyclovir, valacyclovir or famciclovir in the 12 months before the index date to ensure that HZ diagnoses after the index date are new, rather than carried over from HZ episodes prior to the index date.
- Postherpetic neuralgia diagnosis in the 12 months before the index date.
- Censoring events within 30 days after the index date (before the start of follow-up).
Any previous RZV doses before index date (for unvaccinated participants only) using all available data.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.