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Recombinant Zoster Vaccine in Stable SLE Patients

NCT04516408 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2022-10-26

No results posted yet for this study

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. 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.

Conditions

Interventions

BIOLOGICAL

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.

BIOLOGICAL

Placebo

Sterilized water

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Fangfang Sun, MD. · Renji Hospital, Shouth Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516408 on ClinicalTrials.gov