Clinical trial NCT06001606: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Zoster
Systemic Lupus Erythematosus
Vaccine Reaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency of positive humoral vaccine response at 1 month post-dose 2
timeFrame: 3 months
Secondary outcomes:
measure: Frequency of positive humoral vaccine response at 6 months post-dose 2
timeFrame: 8 months
measure: Frequency of humoral responses 12 month post-dose 2
timeFrame: 14 month
measure: Anti-gE antibody concentration at 6 months post-dose 2
timeFrame: 8 months
measure: Anti-gE antibody concentration at 12 months post-dose 2
timeFrame: 14 months
Other outcomes:
measure: SLE flare rate
timeFrame: up to 2 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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.
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.
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.