NCT04516408

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
464

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

August 13, 2020

Last Update Submit

October 25, 2022

Conditions

Herpes ZosterRecombinant Zoster VaccineSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Percent of participants with herpes zoster

    The efficacy of recombinant zoster vaccine in stable systemic lupus patients

    12 months

Secondary Outcomes (4)

  • Immunogenicity

    Baseline, 3 month, and 12 month

  • Percent of participants with lupus flares

    12 months

  • Change of interferon score during follow-up

    12 months

  • Adverse events

    12 months

Study Arms (2)

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.

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.

Biological: Placebo

Interventions

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.

Recombinant zoster vaccine
PlaceboBIOLOGICAL

Sterilized water

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ye, MD

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Herpes ZosterLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fangfang Sun, MD.

    Renji Hospital, Shouth Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangfang Sun, MD.

CONTACT

86 15800901145Fiona_rj@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Herpes Zoster
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 18, 2020

Study Start

April 20, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

CN(1)