Lupus ErythematosusNCT04089930
Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients
An observational study of Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus
- What is being tested?
- Immunogenicity
- Type of treatment
- Vaccines
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: systemic lupus erythematosus (SLE) patients
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus
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.
Read the 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
- Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline
- Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 5 years
- Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 5 years
- Conditions
- Lupus Erythematosus
- Being tested
- Immunogenicity
- Keywords
- herpes zoster, vaccine, lupus
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunogenicityDiagnostic test
anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Those SLE patients who had been given herpes zoster vaccine in our original RCT Receives: Diagnostic Test: Immunogenicity | |
| Placebo | Those SLE patients who had been given placebo vaccination in our original RCT Receives: Diagnostic Test: Immunogenicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response to vaccine
percentage and absolute change in anti-VZV IgG titer from baseline
Measured: 5 years after vaccination
Secondary outcomes (1)
Cell-mediated immune response to vaccine
percentage and absolute change in VZV-stimulated T cell response (T cell spots) from baseline
Measured: 5 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Jun 2020
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- Chi Chiu Mok, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089930
- Sponsor's protocol ID
- NTWC/REC/19088
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2019
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04089930
- Acronym / sponsor ID
- NTWC/REC/19088
- Conditions
- Lupus Erythematosus
- Keywords
- herpes zoster, vaccine, lupus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Collaborators
- The University of Hong Kong
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline
- Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 5 years
- Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 5 years
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | – | Diagnostic Test: ImmunogenicityThose SLE patients who had been given herpes zoster vaccine in our original RCT |
| Placebo | – | Diagnostic Test: ImmunogenicityThose SLE patients who had been given placebo vaccination in our original RCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- systemic lupus erythematosus (SLE) patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunogenicityanti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots) | Diagnostic test | Placebo, Vaccine |
Primary outcome
Humoral immune response to vaccine
Time frame: 5 years after vaccination
percentage and absolute change in anti-VZV IgG titer from baseline
1 secondary outcome
Cell-mediated immune response to vaccine
Time frame: 5 years after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Chiu Mok principal investigator
Tuen Mun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response to vaccine (time frame: 5 years after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.