Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
NCT ID: NCT04748939
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2025-01-31
2026-07-31
Brief Summary
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Detailed Description
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Duration of study: 60 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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vaccine
Shingrix vaccine
recombinant subunit herpes zoster vaccine
vaccine administration
placebo
normal saline injection (0.5mL)
recombinant subunit herpes zoster vaccine
vaccine administration
Interventions
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recombinant subunit herpes zoster vaccine
vaccine administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Tuen Mun Hospital
OTHER_GOV
Responsible Party
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Chi Chiu Mok
Dr
Principal Investigators
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Chi Chiu Mok
Role: PRINCIPAL_INVESTIGATOR
Tuen Mun Hospital
Locations
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Department of Medicine, Tuen Mun Hospital
Hong Kong, , China
Countries
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Central Contacts
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Other Identifiers
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NTWCShingrixstudy
Identifier Type: -
Identifier Source: org_study_id
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