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

Launched by TUEN MUN HOSPITAL · Feb 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a vaccine called Shingrix, which is designed to prevent shingles (also known as herpes zoster), in patients with certain autoimmune diseases. The trial will focus on people aged 18 and older who have conditions like rheumatoid arthritis or lupus and are currently being treated with medications that suppress the immune system. Participants must be stable on their medications for at least four weeks before joining the study.

If you or a family member are eligible and decide to participate, you will receive either the Shingrix vaccine or a placebo (a shot with no active ingredients) to compare the effects. The study aims to see how well the vaccine works and if it is safe for patients who are on these treatments. It's important to know that participants need to be in good health without active infections, and women who can become pregnant will need to use birth control for a year after vaccination. This trial is not yet recruiting, but it will help improve our understanding of how to protect patients with rheumatic diseases from shingles.

Gender

ALL

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)