Clinical trial NCT04748939: Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Herpes Zoster
Keywords: vaccine
rheumatic diseases
immunosuppressive
immunogenicity
biologics
targeted DMARDs
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized controlled trial
Primary purpose: PREVENTION

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

Eligibility criteria: 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)

Primary outcomes:
measure: humoral immune response to Shingrix
timeFrame: week 12 (compared with baseline)
Secondary outcomes:
measure: Humoral immune response
timeFrame: week 52
measure: adverse events
timeFrame: 7 days after injection
measure: adverse events
timeFrame: 4 weeks after injection
measure: flares of underlying diseases
timeFrame: week 26 and 60
measure: herpes zoster infection
timeFrame: week 60
measure: cell mediated response to vaccine
timeFrame: week 12 from baseline
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine, Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital
name: Chi Chiu Mok
role: PRINCIPAL_INVESTIGATOR
References: