Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: recombinant subunit herpes zoster vaccine.
- Who it may be relevant to
- Registry conditions: Herpes Zoster. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Biological recombinant subunit herpes zoster vaccine
vaccine administration
Primary outcome measures
- humoral immune response to Shingrix [Time frame: week 12 (compared with baseline)]
Secondary outcome measures (6)
- Humoral immune response [Time frame: week 52]
- adverse events [Time frame: 7 days after injection]
- adverse events [Time frame: 4 weeks after injection]
- flares of underlying diseases [Time frame: week 26 and 60]
- herpes zoster infection [Time frame: week 60]
- cell mediated response to vaccine [Time frame: week 12 from baseline]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Medicine, Tuen Mun Hospital — Hong Kong
Identifiers
NCT: NCT04748939 · NTWCShingrixstudy