NCT04089930

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Tuen Mun Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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

Conditions

• Lupus Erythematosus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immunogenicity	anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-09-01
• Completion: 2023-10-01
• First posted: 2019-09-13
• Last updated: 2024-02-16

Locations

1 site across 1 country: China