NCT04748939

Brief Summary

A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
5.6 years until next milestone

Study Start

First participant enrolled

September 29, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

February 7, 2021

Last Update Submit

September 28, 2026

Conditions

Herpes Zoster

Keywords

vaccinerheumatic diseasesimmunosuppressiveimmunogenicitybiologicstargeted DMARDs

Outcome Measures

Primary Outcomes (1)

  • humoral immune response to Shingrix

    proportion of patients with 4x fold increase in anti-gE antibody titer

    week 12 (compared with baseline)

Secondary Outcomes (6)

  • Humoral immune response

    week 52

  • adverse events

    7 days after injection

  • adverse events

    4 weeks after injection

  • flares of underlying diseases

    week 26 and 60

  • herpes zoster infection

    week 60

  • +1 more secondary outcomes

Study Arms (2)

vaccine

ACTIVE COMPARATOR

Shingrix vaccine

Biological: recombinant subunit herpes zoster vaccine

placebo

PLACEBO COMPARATOR

normal saline injection (0.5mL)

Biological: recombinant subunit herpes zoster vaccine

Interventions

recombinant subunit herpes zoster vaccineBIOLOGICAL

vaccine administration

Also known as: Shingrix
placebovaccine

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
  • Age ≥18 years
  • Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:
  • Prednisolone ≥20mg/kg/day ± mycophenolate mofetil, azathioprine or the calcineurin inhibitors
  • Cyclophosphamide (intravenous pulses or daily oral)
  • B-cell depleting biological agents and their biosimilars eg. belimumab, anti-CD20 agents (next scheduled dose should be arranged to at least 12 weeks after study entry for rituximab or obinutuzumab)
  • Anti-TNFα biological agents and their biosimilars eg. infliximab, etanercept, adalimumab, golimumab, certolizumab
  • Anti-interleukin-6 biological agents eg. tocilizumab, sarilumab
  • Other biological agents eg. abatacept, ustekinumab, secukinumab, ixekizumab
  • The JAK inhibitors eg. tofacitinib, baricitinib, upadacitinib
  • Female patients with reproductive potential are allowed to participate in this study provided that they are willing to practice contraception for until at least 12 months after vaccination
  • Willing to comply with all study procedures

You may not qualify if:

  • Active infection, including upper respiratory tract infection
  • Active HZ infection
  • Active untreated tuberculosis
  • HIV infection
  • History of HZ or varicella vaccination in the past
  • History of allergy to any vaccines
  • Patients who are pregnant or plan to become pregnancy within one year of study entry
  • Lactating women
  • Patients who cannot give a written consent (mentally incapable or illiterate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Herpes ZosterRheumatic Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chi Chiu Mok

    Tuen Mun Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind for the identity of the drugs
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double-blind randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 10, 2021

Study Start

September 29, 2026

Primary Completion

September 29, 2026

Study Completion

September 29, 2026

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)