Immunogenicity, Reactogenicity of Shingrix in SLE

Systemic Lupus Erythematosus Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001606
• Other study ID #: H-2303-017-1410
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2023
• Est. completion date: April 24, 2025

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Jin Kyun Park, MD
• Phone: 82-2-2072-4765
• Email: jinkyunpark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: April 24, 2025
• Est. primary completion date: April 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Vaccine Reaction
• Zoster

Intervention

Drug:
• Shingrix
Shingrix vaccination
• Placebo
Placebo vaccination

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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 — View 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 tri — View 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 On — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SLE flare rate		up to 2 months
Primary	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	Frequency of positive humoral vaccine response at 6 months post-dose 2		8 months
Secondary	Frequency of humoral responses 12 month post-dose 2		14 month
Secondary	Anti-gE antibody concentration at 6 months post-dose 2		8 months
Secondary	Anti-gE antibody concentration at 12 months post-dose 2		14 months