Shingrix in Patients With Rheumatic Diseases: a Double-bl... | NCT04748939

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

NCT04748939

Sponsor

Tuen Mun Hospital

Status

Not yet recruiting

Last Update Posted

Aug 6, 2024Actual

Enrollment

140Estimated

Phase

Phase 4

Conditions

Herpes Zoster

Interventions

recombinant subunit herpes zoster vaccine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2025Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Feb 7, 2021

First Submission Date that Met QC Criteria

Feb 8, 2021

First Posted Date

Feb 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2024

Last Update Posted Date

Aug 6, 2024Actual

Description Module

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

Duration of study: 60 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
recombinant subunit herpes zoster vaccine	Biological	vaccine administration	placebo vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
humoral immune response to Shingrix	proportion of patients with 4x fold increase in anti-gE antibody titer	week 12 (compared with baseline)

Secondary Outcomes

Measure	Description	Time Frame
Humoral immune response	proportion of patients with 4x fold increase in anti-gE antibody titer	week 52
adverse events	solicited	7 days after injection

Other Outcomes

Not provided

Eligibility Module

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:
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
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Chi Chiu Mok, MD, FRCP	Contact	852-37677518		ccmok2006@gmail.com
Becky Fong	Contact	852-24685111		becky_fongls@yahoo.com.hk

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases