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

2019-09-19 03:56:38 | BioPortfolio

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.

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 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

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 4 years

3. Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 4 years

Study Design

Conditions

Lupus Erythematosus

Intervention

Immunogenicity

Location

Department of Medicine, Tuen Mun Hospital
Hong Kong
China
000

Status

Not yet recruiting

Source

Tuen Mun Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-19T03:56:38-0400

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