Immunogenicity, Reactogenicity of Shingrix in SLE

August 17, 2023 updated by: Seoul National University Hospital

Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo vaccination
Experimental: Shingrix
Drug: Shingrix
Shingrix vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of positive humoral vaccine response at 1 month post-dose 2
Time Frame: 3 months
Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of positive humoral vaccine response at 6 months post-dose 2
Time Frame: 8 months
8 months
Frequency of humoral responses 12 month post-dose 2
Time Frame: 14 month
14 month
Anti-gE antibody concentration at 6 months post-dose 2
Time Frame: 8 months
8 months
Anti-gE antibody concentration at 12 months post-dose 2
Time Frame: 14 months
14 months

Other Outcome Measures

Outcome Measure
Time Frame
SLE flare rate
Time Frame: up to 2 months
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

April 24, 2025

Study Completion (Estimated)

April 24, 2025

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2303-017-1410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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