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

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.

Study Overview

• Status: Completed
• Conditions: Lupus Erythematosus
• Intervention / Treatment: Diagnostic test: Immunogenicity

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

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

• Study Contact: Name: Chi Chiu MOK, MD, FRCP; Phone Number: 952-24685389; Email: ccmok2005@yahoo.com
• Study Contact Backup: Name: Becky Fong; Phone Number: 852-24686118; Email: becky_fongls@yahoo.com.hk

Study Locations

• China
  • Hong Kong, China, 000
    • Department of Medicine, Tuen Mun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

systemic lupus erythematosus (SLE) patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccine; Those SLE patients who had been given herpes zoster vaccine in our original RCT	Diagnostic test: Immunogenicity; anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)
Placebo; Those SLE patients who had been given placebo vaccination in our original RCT	Diagnostic test: Immunogenicity; anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)

What is the study measuring?

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	5 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	5 years after vaccination

Collaborators and Investigators

• Sponsor: Tuen Mun Hospital
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Chi Chiu Mok, Tuen Mun Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: vaccine; lupus; herpes zoster
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Lupus Erythematosus, Systemic; Herpes Zoster
• Other Study ID Numbers: NTWC/REC/19088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No