Reduced Vaccine Response to HZ/su in SLE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorSeoul National University Hospital
About this trial
The goal of this observational study is to compare the vaccine response to the 2 doses of the adjuvanted herpes zoster subunit vaccine(HZ/su, "Shingrix") in patients with SLE and the age-, sex-, ethnicity-matched controls without autoimmune disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females ≥ 50 years of age at time of consent
≥ 4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (14, 15)
Clinically stable SLE
Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
Disqualifiers
Pregnant or lactating females
Acute infection with temperature >38C at the time of vaccination
Previous anaphylactic response to vaccine components or to egg
History of Guillain-Barre syndrome or demyelinating syndromes
Trial population
SLE patients who receive medical care at Seoul National University Hospital
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: SLE patients
Group B: Control subjects
Trial outcomes
Primary outcomes
1
Cell Mediated Immunity (CMI)
Frequency of positive cellular vaccine response to HZ/su at 1 month post-dose 2
Time frame
from the time of vaccination to 1month post-dose 2Secondary outcomes
1
Long-term CMI response
Frequency of positive cellular responses 1 month post-dose 2 and 1, 2, 3, 4, and 5 year(s) post-dose 2.
Time frame
from 1month post-dose 2 to 5year post-dose 22
gE-specific CD4 T-cell
Frequencies of gE-specific CD4 T-cell (expressing ≥2 of 4 assessed activation markers) at baseline, 1 month post-dose 2, and 1, 2, 3, 4, and 5 year(s) post-dose 2.
Time frame
from the time of vaccination to 5 year post-dose 23
Humoral response
Humoral response (anti-gE-Ig level) at baseline, 1 month post-dose 2, and 1, 2, 3, 4, and 5 year(s) post-dose 2.
Time frame
from the time of vaccination to 5 year post-dose 2Other outcomes
1
Zoster reactivation
Incidence of zoster reactivation during the study duration
Time frame
from 1month post-dose 2 to 5year post-dose 22
Cytokine level
Changes of cytokine level at baseline and 1 month post-dose 2
Time frame
from the time of vaccination to 1month post-dose 23
Adverse Events
Adverse events over time
Time frame
from the time of vaccination to 5 year post-dose 2Sponsors and contacts
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Source ClinicalTrials.gov