Recombinant Zoster Vaccine in Stable SLE Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity, Reactogenicity of Shingrix in SLE

NCT06001606

Zoster Systemic Lupus Erythematosus Vaccine Reaction

UNKNOWN PHASE3

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

NCT04089930

Lupus Erythematosus

COMPLETED

Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

NCT02885610

Systemic Lupus Erythematosus

COMPLETED PHASE2

Zostavax in Systemic Lupus Erythematosus

NCT01474720

Systemic Lupus Erythematosus

COMPLETED PHASE1

Safety of the Herpes Zoster Subunit Vaccine in Lupus

NCT05559671

Systemic Lupus Erythematosus

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herpes Zoster Recombinant Zoster Vaccine Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Herpes Zoster

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Quadruple

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recombinant zoster vaccine

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.

Group Type EXPERIMENTAL

Recombinant zoster vaccine

Intervention Type BIOLOGICAL

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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Sterilized water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant zoster vaccine

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.

Intervention Type BIOLOGICAL

Placebo

Sterilized water

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 50 years old
2. 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;
3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
4. Sign the informed consent.

Exclusion Criteria

1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
2. Exposure to cyclophosphamide within the past half year.
3. Exposure to rituximab within the past one year.
4. History of herpes zoster within the past three months;
5. Pregnancy or lactation;
6. History of malignancy.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No