Lupus Erythematosus Clinical Trial
Official title:
Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus
NCT number | NCT04089930 |
Other study ID # | NTWC/REC/19088 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | October 1, 2023 |
Verified date | February 2024 |
Source | Tuen Mun Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | |
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) |
Country | Name | City | State |
---|---|---|---|
China | Department of Medicine, Tuen Mun Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Tuen Mun Hospital | The University of Hong Kong |
China,
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 |
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