Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT

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

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)