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

Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089930
• Other study ID #: NTWC/REC/19088
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2024
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Herpes Zoster
• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Diagnostic Test:
• Immunogenicity
anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)

Locations

Country	Name	City	State
China	Department of Medicine, Tuen Mun Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Tuen Mun Hospital	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral immune response to vaccine	percentage and absolute change in anti-VZV IgG titer from baseline	5 years after vaccination
Secondary	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