Herpes Zoster
Conditions
Keywords
vaccine, rheumatic diseases, immunosuppressive, immunogenicity, biologics, targeted DMARDs
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
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
vaccine administration
Sponsors
Tuen Mun Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blind for the identity of the drugs
Intervention model description
double-blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients: 1. Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides 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
for patients: 1. Active infection, including upper respiratory tract infection 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| humoral immune response to Shingrix | week 12 (compared with baseline) | proportion of patients with 4x fold increase in anti-gE antibody titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response | week 52 | proportion of patients with 4x fold increase in anti-gE antibody titer |
| adverse events | 7 days after injection | solicited |
| flares of underlying diseases | week 26 and 60 | disease flares |
| herpes zoster infection | week 60 | herpes zoster infection |
| cell mediated response to vaccine | week 12 from baseline | in 40 patients (20 from each arm); number of IFNγ-secreting CD4+ T cell colonies on ELISPOT assay |
Countries
China
Contacts
Primary ContactChi Chiu Mok, MD, FRCP
Backup ContactBecky Fong
Outcome results
None listed