NCT02477150

Brief Summary

To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

June 17, 2015

Last Update Submit

September 2, 2019

Conditions

Systemic Lupus Erythematosus

Keywords

lupus

Outcome Measures

Primary Outcomes (1)

  • antibody rise to varicella zoster virus

    Difference between the two groups in the proportion of patients who achieve a two-fold rise in IgG to VZV at week 6 post-vaccination compared to baseline

    6 weeks

Secondary Outcomes (2)

  • safety (incidence of herpes zoster reactivation or chickenpox infection)

    week 6

  • T cell response to VZV

    week 6

Study Arms (2)

SLE (vaccine)

ACTIVE COMPARATOR

Zostavax SC injection (0.65ml)

Biological: Zostavax

SLE (placebo)

PLACEBO COMPARATOR

Placebo SC injection (normal saline 0.65ml)

Biological: placebo

Interventions

ZostavaxBIOLOGICAL

Vaccination of a zoster vaccine (Zostavax)

SLE (vaccine)
placeboBIOLOGICAL

placebo administration

SLE (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SLE patients who fulfill ≥4 of the 1997 ACR (17) or the 2012 SLICC/ACR criteria for SLE (18)
  • Age ≥18 years
  • Clinically inactive disease with SELENA-SLEDAI score \<6 (see below) and receiving stable dose of immunosuppressive agents for ≥6 months
  • History of varicella (chickenpox) or herpes zoster infection in the past
  • Willing to comply with all study procedures

You may not qualify if:

  • Active infection, including upper respiratory tract infection
  • Active untreated tuberculosis
  • Human immunodeficiency virus (HIV) infection
  • Lymphocyte count \<500/mm2
  • Reduced serum IgG, IgA or IgM level (below normal range)
  • Serum creatinine \>200umol/L
  • History of hematological malignancies (eg. lymphoma, leukaemia) and other solid tumors
  • Patients receiving doses of immunosuppressive agents exceeding the following:
  • Prednisolone (\>15mg) or equivalent
  • Azathioprine (\>100mg/day)
  • Mycophenolate mofetil (\>1000mg/day)
  • Cyclosporin A (\>100mg/day)
  • Tacrolimus (\>3mg/day)
  • Methotrextate (\>15mg/week)
  • Cyclophosphamide (any dose)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, 000, China

Location

Related Publications (1)

  • Mok CC, Chan KH, Ho LY, Fung YF, Fung WF, Woo PCY. Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial. Ann Rheum Dis. 2019 Dec;78(12):1663-1668. doi: 10.1136/annrheumdis-2019-215925. Epub 2019 Sep 17.

    PMID: 31530556DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • CC Mok, MD

    Tuen Mun Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 22, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

CN(1)