Clincosm LogoSign in Get a demo

Immunogenicity, Reactogenicity of Shingrix in SLE

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06001606
Collaborator
(none)
63
Enrollment
1
Location
2
Arms
23.6
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
Apr 24, 2025
Anticipated Study Completion Date :
Apr 24, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Shingrix

Drug: Shingrix
Shingrix vaccination
Placebo Comparator: Placebo

Drug: Placebo
Placebo vaccination

Outcome Measures

Primary Outcome Measures

  1. Frequency of positive humoral vaccine response at 1 month post-dose 2 [3 months]

    Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration

Secondary Outcome Measures

  1. Frequency of positive humoral vaccine response at 6 months post-dose 2 [8 months]

  2. Frequency of humoral responses 12 month post-dose 2 [14 month]

  3. Anti-gE antibody concentration at 6 months post-dose 2 [8 months]

  4. Anti-gE antibody concentration at 12 months post-dose 2 [14 months]

Other Outcome Measures

  1. SLE flare rate [up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT06001606
Other Study ID Numbers:
  • H-2303-017-1410
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Herpes Zoster
Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Aug 21, 2023