Herpes ZosterNCT04516408
Recombinant Zoster Vaccine in Stable SLE Patients
A study testing Recombinant zoster vaccine in people with Herpes Zoster and Recombinant Zoster Vaccine, run by RenJi Hospital at 1 site in China.
Trial summary
The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and they account for about two-thirds of the events. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Herpes Zoster, Recombinant Zoster Vaccine, Systemic Lupus Erythematosus
- What is being tested?
- Recombinant zoster vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 30 Sep 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years old
- The disease status is stable (score≤ 6 at screening on SELENA-SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one BILAG B;
- A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
- Sign the informed consent.
Who cannot join
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
- Exposure to cyclophosphamide within the past half year.
- Exposure to rituximab within the past one year.
- History of herpes zoster within the past three months;
- Pregnancy or lactation;
- History of malignancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shuang Ye, MD
Shanghai, Shanghai Municipality
Shuang Ye, MD, +8613817615871, ye_shuang2000@163.com
Huijing Wang, postgraduate, +8618267851823, whj30813@163.com
About this study
Official title: Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)
The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and they account for about two-thirds of the events. And our previous study indicated that recent various VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. In addition, herpes zoster may trigger lupus flare. A case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.
- Being tested
- Recombinant zoster vaccine, Placebo
- Medical subject headings
- Herpes Zoster, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant zoster vaccineBiological
Recombinant zoster vaccine (RZV) is indicated for prevention of herpes zoster in adults aged ≥ 50 years old. RZV contains a varicella zoster virus glycoprotein E antigen and the AS01B adjuvant system.
PlaceboBiological
Sterilized water
| Study group | Role | What they receive |
|---|---|---|
| Recombinant zoster vaccine | Experimental | Eligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the vaccine 2 months apart. Receives: Biological: Recombinant zoster vaccine |
| Placebo | Placebo comparator | Eligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the placebo (sterilized water) 2 months apart. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with herpes zoster
The efficacy of recombinant zoster vaccine in stable systemic lupus patients
Measured: 12 months
Secondary outcomes (4)
Immunogenicity
Humoral immunity was measured as geometric mean concentrations (GMCs) of serum anti-gE antibodies (ELISA), and CMI was measured as the frequency of CD4 T cells expressing ≥ 2 of 4 selected activation markers (interferon-γ, interleukin-2, tumour necrosis factor-α and CD40 ligand) per 10^6 CD4 T cells after stimulation with gE peptides (hereafter referred to as CD4^2+ T cells)
Measured: Baseline, 3 month, and 12 month
Percent of participants with lupus flares
either minor/moderate flare or major flare defined by SLEDAI Flare Index
Measured: 12 months
Change of interferon score during follow-up
Interferon score is detected at each visit, the time of herpes zoster and lupus flare.
Measured: 12 months
Adverse events
To evaluate for adverse effects following immunization patients will submit the adverse effects by app tracking system.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start20 Apr 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Herpes Zoster
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fangfang Sun, MD., Principal investigator, Renji Hospital, Shouth Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516408
- Sponsor's protocol ID
- Vtrial
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)
- ClinicalTrials.gov ID
- NCT04516408
- Acronym / sponsor ID
- Vtrial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 18 Aug 2020 (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.
The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and they account for about two-thirds of the events. And our previous study indicated that recent various VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. In addition, herpes zoster may trigger lupus flare. A case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Herpes Zoster
| Arm | Type | Receives |
|---|---|---|
| Recombinant zoster vaccine | Experimental | Biological: Recombinant zoster vaccineEligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the vaccine 2 months apart. |
| Placebo | Placebo comparator | Biological: PlaceboEligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the placebo (sterilized water) 2 months apart. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years old
- The disease status is stable (score≤ 6 at screening on SELENA-SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one BILAG B;
- A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min;
- Exposure to cyclophosphamide within the past half year.
- Exposure to rituximab within the past one year.
- History of herpes zoster within the past three months;
- Pregnancy or lactation;
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 |
|---|---|---|
| Recombinant zoster vaccineRecombinant zoster vaccine (RZV) is indicated for prevention of herpes zoster in adults aged ≥ 50 years old. RZV contains a varicella zoster virus glycoprotein E antigen and the AS01B adjuvant system. | Biological | Recombinant zoster vaccine |
| PlaceboSterilized water | Biological | Placebo |
Primary outcome
Percent of participants with herpes zoster
Time frame: 12 months
The efficacy of recombinant zoster vaccine in stable systemic lupus patients
4 secondary outcomes
Immunogenicity
Time frame: Baseline, 3 month, and 12 month
Percent of participants with lupus flares
Time frame: 12 months
Change of interferon score during follow-up
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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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.
Fangfang Sun, MD. principal investigator
Renji Hospital, Shouth Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant zoster vaccine in people with Herpes Zoster and Recombinant Zoster Vaccine, run by RenJi 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangfang Sun, MD. (86 15800901145, Fiona_rj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with herpes zoster (time frame: 12 months). 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 26 Oct 2022.