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

Tuen Mun Hospital68 enrolled

Overview

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.

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 5 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 5 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 5 years compared to baseline Secondary outcomes 1. Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline 2. Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 5 years 3. Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 5 years

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Erythematosus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Age ≥18 years 3. Having completed the original RCT of HZ vaccine vs placebo 4. Having been followed for 5 years since HZ vaccination or placebo injection 5. Willing to comply with all study procedures Exclusion Criteria: 1. Patients who refuse to participate in this long-term extension study 2. Patients in the placebo group who have subsequently received HZ vaccination 3. Patients who cannot give a written consent (mentally incapable or illiterate)

Outcomes

Primary Outcomes

Humoral immune response to vaccine

percentage and absolute change in anti-VZV IgG titer from baseline

Time frame: 5 years after vaccination

Secondary Outcomes

Cell-mediated immune response to vaccine

percentage and absolute change in VZV-stimulated T cell response (T cell spots) from baseline