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

NCT04089930 | Completed

• 1 other identifier: NTWC/REC/19088
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus Erythematosus

Keywords

herpes zoster; vaccine; lupus

Outcome Measures

Primary Outcomes (1)

• Humoral immune response to vaccine

  percentage and absolute change in anti-VZV IgG titer from baseline

  5 years after vaccination

Secondary Outcomes (1)

• Cell-mediated immune response to vaccine

  5 years after vaccination

Study Arms (2)

Vaccine

Those SLE patients who had been given herpes zoster vaccine in our original RCT

Diagnostic Test: Immunogenicity

Placebo

Those SLE patients who had been given placebo vaccination in our original RCT

Diagnostic Test: Immunogenicity

Interventions

Immunogenicity DIAGNOSTIC_TEST

anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)

Placebo; Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

systemic lupus erythematosus (SLE) patients

You may qualify if:

• 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
• Age ≥18 years
• Having completed the original RCT of HZ vaccine vs placebo
• Having been followed for 5 years since HZ vaccination or placebo injection
• Willing to comply with all study procedures

You may not qualify if:

• Patients who refuse to participate in this long-term extension study
• Patients in the placebo group who have subsequently received HZ vaccination
• Patients who cannot give a written consent (mentally incapable or illiterate)

Sponsors & Collaborators

• Tuen Mun Hospital: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, 000, China

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Immunogenicity, Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccine Development; Investigative Techniques; Immune System Phenomena

Study Officials

• Chi Chiu Mok

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: June 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)