Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
63 participants
INTERVENTIONAL
2023-05-08
2025-04-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Recombinant Zoster Vaccine in Stable SLE Patients
NCT04516408
Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients
NCT04089930
Safety of the Herpes Zoster Subunit Vaccine in Lupus
NCT05559671
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT01196091
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
NCT07299422
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Shingrix
Shingrix
Shingrix vaccination
Placebo
Placebo
Placebo vaccination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Shingrix
Shingrix vaccination
Placebo
Placebo vaccination
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
* Clinically stable SLE
* Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
* Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
* Antimalarials (≤400 mg/day)
* Azathioprine (≤3 mg/kg/day)
* Mycophenolate mofetil (≤3 mg/day)
* Tacrolimus (≤5mg/day)
* Methotrexate (≤20mg/week)
* Cyclosphosphamide (≤1mg/BSA/month)
* Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion Criteria
* Acute infection with T \>38°C at the time of vaccination
* Previous anaphylactic response to vaccine components or to egg
* History of Guillain-Barre syndrome or demyelinating syndromes
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
Park JK, Kim M, Jung JI, Kim JY, Jeong H, Park JW, Winthrop KL, Lee EB. Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. 2024 Jun;6(6):e352-e360. doi: 10.1016/S2665-9913(24)00084-5. Epub 2024 May 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-2303-017-1410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.