Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04089930
Study type	Observational
Source	Tuen Mun Hospital
Contact
Status	Completed
Phase
Start date	June 1, 2020
Completion date	October 1, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms