Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients

Study Overview
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Brief Summary
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A recent randomized controlled trial (RCT) from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated herpes zoster (HZ) vaccine (Zostavax) in stable systemic lupus erythematosus (SLE) patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of Zostavax in SLE patients. This prompts the current extension study which is planned to evaluate the long-term immunogenicity and efficacy of Zostavax in our original patient cohort.

Detailed Description
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A recent RCT from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated Zostavax in stable SLE patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of the HZ vaccine, Zostavax, in SLE patients. Patients who had completed the original RCT and had been followed for 4 years since HZ vaccination or placebo injection were invited to participate in this extension study. Blood samples will be taken for a repeat assessment of the humoral and cell-mediated response to VZV at 4 years. Outcomes of interest Primary outcome Difference between the two groups in the proportion of patients who have a persistent and 50% increase in IgG to VZV (humoral response to Zostavax) at 4 years compared to baseline Secondary outcomes Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 4 years Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 4 years

Official Title
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Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus

Conditions
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Lupus Erythematosus

Intervention / Treatment
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* Diagnostic Test: Immunogenicity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SLE patients who fulfill ≥4 of the 1997 ACR or the 2012 SLICC/ACR criteria for SLE or healthy controls who had participated in the original RCT Age ≥18 years Having completed the original RCT of HZ vaccine vs placebo Having been followed for 4 years since HZ vaccination or placebo injection Willing to comply with all study procedures Exclusion Criteria: Patients who refuse to participate in this long-term extension study Patients in the placebo group who have subsequently received HZ vaccination Patients who cannot give a written consent (mentally incapable or illiterate)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccine<br>Those SLE patients who had been given herpes zoster vaccine in our original RCT | Diagnostic Test: Immunogenicity<br>* anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)<br>|
| Placebo<br>Those SLE patients who had been given placebo vaccination in our original RCT | Diagnostic Test: Immunogenicity<br>* anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immune response to vaccine | percentage and absolute change in anti-VZV IgG titer from baseline | 4 years after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell-mediated immune response to vaccine | percentage and absolute change in VZV-stimulated T cell response (T cell spots) from baseline | 4 years after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herpes zoster, vaccine, lupus