Status:
NOT_YET_RECRUITING
Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04748939
Start Date
January 1 2025
End Date
July 1 2026
Last Update
August 6 2024
Active Locations (1)
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1
Department of Medicine, Tuen Mun Hospital
Hong Kong, China