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Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT

Primary Purpose

Herpes Zoster

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
recombinant subunit herpes zoster vaccine
Sponsored by
Tuen Mun Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring vaccine, rheumatic diseases, immunosuppressive, immunogenicity, biologics, targeted DMARDs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for patients:

  1. Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
  2. Age ≥18 years

  3. Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:

    1. Prednisolone ≥20mg/kg/day ± mycophenolate mofetil, azathioprine or the calcineurin inhibitors
    2. Cyclophosphamide (intravenous pulses or daily oral)
    3. 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)
    4. Anti-TNFα biological agents and their biosimilars eg. infliximab, etanercept, adalimumab, golimumab, certolizumab
    5. Anti-interleukin-6 biological agents eg. tocilizumab, sarilumab
    6. Other biological agents eg. abatacept, ustekinumab, secukinumab, ixekizumab
    7. The JAK inhibitors eg. tofacitinib, baricitinib, upadacitinib
  4. 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
  5. Willing to comply with all study procedures

Exclusion criteria for patients:

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

Sites / Locations

  • Department of Medicine, Tuen Mun Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vaccine

placebo

Arm Description

Shingrix vaccine

normal saline injection (0.5mL)

Outcomes

Primary Outcome Measures

humoral immune response to Shingrix
proportion of patients with 4x fold increase in anti-gE antibody titer

Secondary Outcome Measures

Humoral immune response
proportion of patients with 4x fold increase in anti-gE antibody titer
adverse events
solicited
adverse events
unsolicited
flares of underlying diseases
disease flares
herpes zoster infection
herpes zoster infection
cell mediated response to vaccine
in 40 patients (20 from each arm); number of IFNγ-secreting CD4+ T cell colonies on ELISPOT assay

Full Information

First Posted
February 7, 2021
Last Updated
February 20, 2023
Sponsor
Tuen Mun Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04748939
Brief Title
Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
Official Title
Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuen Mun Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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. Duration of study: 60 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
vaccine, rheumatic diseases, immunosuppressive, immunogenicity, biologics, targeted DMARDs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blind for the identity of the drugs
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vaccine
Arm Type
Active Comparator
Arm Description
Shingrix vaccine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
normal saline injection (0.5mL)
Intervention Type
Biological
Intervention Name(s)
recombinant subunit herpes zoster vaccine
Other Intervention Name(s)
Shingrix
Intervention Description
vaccine administration
Primary Outcome Measure Information:
Title
humoral immune response to Shingrix
Description
proportion of patients with 4x fold increase in anti-gE antibody titer
Time Frame
week 12 (compared with baseline)
Secondary Outcome Measure Information:
Title
Humoral immune response
Description
proportion of patients with 4x fold increase in anti-gE antibody titer
Time Frame
week 52
Title
adverse events
Description
solicited
Time Frame
7 days after injection
Title
adverse events
Description
unsolicited
Time Frame
4 weeks after injection
Title
flares of underlying diseases
Description
disease flares
Time Frame
week 26 and 60
Title
herpes zoster infection
Description
herpes zoster infection
Time Frame
week 60
Title
cell mediated response to vaccine
Description
in 40 patients (20 from each arm); number of IFNγ-secreting CD4+ T cell colonies on ELISPOT assay
Time Frame
week 12 from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for patients: 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 Exclusion criteria for patients: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Chiu Mok, MD, FRCP
Phone
852-37677518
Email
ccmok2006@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Fong
Phone
852-24685111
Email
becky_fongls@yahoo.com.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Chiu Mok
Organizational Affiliation
Tuen Mun Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Tuen Mun Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT

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