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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04748939
• Other study ID #: NTWCShingrixstudy
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Tuen Mun Hospital
• Contact: Chi Chiu Mok, MD, FRCP
• Phone: 852-37677518
• Email: ccmok2006[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-TNFa 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)

Related Conditions & MeSH terms

• Collagen Diseases
• Herpes Zoster
• Rheumatic Diseases

Intervention

Biological:
• recombinant subunit herpes zoster vaccine
vaccine administration

Locations

Country	Name	City	State
China	Department of Medicine, Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	humoral immune response to Shingrix	proportion of patients with 4x fold increase in anti-gE antibody titer	week 12 (compared with baseline)
Secondary	Humoral immune response	proportion of patients with 4x fold increase in anti-gE antibody titer	week 52
Secondary	adverse events	solicited	7 days after injection
Secondary	adverse events	unsolicited	4 weeks after injection
Secondary	flares of underlying diseases	disease flares	week 26 and 60
Secondary	herpes zoster infection	herpes zoster infection	week 60
Secondary	cell mediated response to vaccine	in 40 patients (20 from each arm); number of IFN?-secreting CD4+ T cell colonies on ELISPOT assay	week 12 from baseline