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

NCT04748939 | Not Yet Recruiting Phase 4

• 1 other identifier: NTWCShingrixstudy
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Herpes Zoster

Keywords

vaccine; rheumatic diseases; immunosuppressive; immunogenicity; biologics; targeted 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

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 vaccine BIOLOGICAL

vaccine administration

Also known as: Shingrix

placebo; vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)

Sponsors & Collaborators

• Tuen Mun Hospital: lead

Study Sites (1)

Department of Medicine, Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Herpes Zoster; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chi Chiu Mok

  Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Chiu Mok, MD, FRCP

CONTACT

852-37677518; ccmok2006@gmail.com

Becky Fong

CONTACT

852-24685111; becky_fongls@yahoo.com.hk

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
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: double-blind randomized controlled trial

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 10, 2021
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)