Back to resultsImmunogenicity, Reactogenicity of Shingrix in SLE
Primary Purpose
Zoster, Systemic Lupus Erythematosus, Vaccine Reaction
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Shingrix
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Zoster
Eligibility Criteria
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 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: Pregnant or lactating females 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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Shingrix
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Frequency of positive humoral vaccine response at 6 months post-dose 2
Frequency of humoral responses 12 month post-dose 2
Anti-gE antibody concentration at 6 months post-dose 2
Anti-gE antibody concentration at 12 months post-dose 2
Full Information
NCT ID
NCT06001606
First Posted
May 1, 2023
Last Updated
August 17, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06001606
Brief Title
Immunogenicity, Reactogenicity of Shingrix in SLE
Official Title
Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
April 24, 2025 (Anticipated)
Study Completion Date
April 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zoster, Systemic Lupus Erythematosus, Vaccine Reaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shingrix
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Shingrix
Intervention Description
Shingrix vaccination
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo vaccination
Primary Outcome Measure Information:
Title
Frequency of positive humoral vaccine response at 1 month post-dose 2
Description
Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frequency of positive humoral vaccine response at 6 months post-dose 2
Time Frame
8 months
Title
Frequency of humoral responses 12 month post-dose 2
Time Frame
14 month
Title
Anti-gE antibody concentration at 6 months post-dose 2
Time Frame
8 months
Title
Anti-gE antibody concentration at 12 months post-dose 2
Time Frame
14 months
Other Pre-specified Outcome Measures:
Title
SLE flare rate
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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:
Pregnant or lactating females
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Kyun Park, MD
Phone
82-2-2072-4765
Email
jinkyunpark@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Bong Lee, MD PhD
Phone
82-2-2072-3944
Email
leb7616@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ju Yeon Kim, MD
Phone
82-2-2072-2957
Email
simple0693@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35930728
Citation
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.
Results Reference
result
PubMed Identifier
28468794
Citation
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.
Results Reference
result
PubMed Identifier
29572291
Citation
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.
Results Reference
result
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Immunogenicity, Reactogenicity of Shingrix in SLE
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