Immunogenicity, Reactogenicity of Shingrix in SLE

NCT06001606 | Unknown Phase 3

• 1 other identifier: H-2303-017-1410
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Zoster; Systemic Lupus Erythematosus; Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

  8 months

• Anti-gE antibody concentration at 12 months post-dose 2

  14 months

Other Outcomes (1)

• SLE flare rate

  up to 2 months

Study Arms (2)

Shingrix

EXPERIMENTAL

Drug: Shingrix

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Shingrix DRUG

Shingrix vaccination

Shingrix

Placebo DRUG

Placebo vaccination

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 35930728 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.

  PMID: 28468794 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.

  PMID: 29572291 RESULT

• 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.

  PMID: 38710192 DERIVED

MeSH Terms

Conditions

Herpes Zoster; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jin Kyun Park, MD

CONTACT

82-2-2072-4765; jinkyunpark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: August 21, 2023
• Study Start: May 8, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)