Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients
- Conditions
- Lupus Erythematosus
- Interventions
- Diagnostic Test: Immunogenicity
- Registration Number
- NCT04089930
- Lead Sponsor
- Tuen Mun Hospital
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vaccine Immunogenicity Those SLE patients who had been given herpes zoster vaccine in our original RCT Placebo Immunogenicity Those SLE patients who had been given placebo vaccination in our original RCT
- Primary Outcome Measures
Name Time Method Humoral immune response to vaccine 5 years after vaccination percentage and absolute change in anti-VZV IgG titer from baseline
- Secondary Outcome Measures
Name Time Method Cell-mediated immune response to vaccine 5 years after vaccination percentage and absolute change in VZV-stimulated T cell response (T cell spots) from baseline
Trial Locations
- Locations (1)
Department of Medicine, Tuen Mun Hospital
🇨🇳Hong Kong, China