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To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shingrix | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shingrix | Drug | Shingrix vaccination |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of positive humoral vaccine response at 1 month post-dose 2 | Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of positive humoral vaccine response at 6 months post-dose 2 | 8 months | |
| Frequency of humoral responses 12 month post-dose 2 | 14 month | |
| Anti-gE antibody concentration at 6 months post-dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| SLE flare rate | up to 2 months |
Inclusion Criteria:
Males or females ≥ 19 years of age at time of consent
≥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
Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Kyun Park, MD | Contact | 82-2-2072-4765 | jinkyunpark@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35930728 | Result | 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. | |
| 28468794 |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Drug |
Placebo vaccination |
|
| 8 months |
| Anti-gE antibody concentration at 12 months post-dose 2 | 14 months |
| Result |
| 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. |
| 29572291 | Result | 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. |
| 38710192 | Derived | 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. |
| D007239 | Infections |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |