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

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ClinicalTrials.gov Identifier: NCT04089930
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Chi Chiu Mok, 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.

Condition or disease Intervention/treatment
Lupus Erythematosus 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 4 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 4 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 4 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 4 years
  3. Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 4 years

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Shingles

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)




Primary Outcome Measures :
  1. Humoral immune response to vaccine [ Time Frame: 4 years after vaccination ]
    percentage and absolute change in anti-VZV IgG titer from baseline


Secondary Outcome Measures :
  1. Cell-mediated immune response to vaccine [ Time Frame: 4 years after vaccination ]
    percentage and absolute change in VZV-stimulated T cell response (T cell spots) from baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
systemic lupus erythematosus (SLE) patients
Criteria

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 4 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089930


Contacts
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Contact: Chi Chiu MOK, MD, FRCP 952-24685389 ccmok2005@yahoo.com
Contact: Becky Fong 852-24686118 becky_fongls@yahoo.com.hk

Locations
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China
Department of Medicine, Tuen Mun Hospital
Hong Kong, China, 000
Sponsors and Collaborators
Tuen Mun Hospital
The University of Hong Kong
Investigators
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Principal Investigator: Chi Chiu Mok Tuen Mun Hospital

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Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT04089930     History of Changes
Other Study ID Numbers: NTWC/REC/19088
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
herpes zoster
vaccine
lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Herpes Zoster
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs