Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
- Conditions
- Herpes Zoster
- Registration Number
- NCT04748939
- Lead Sponsor
- Tuen Mun Hospital
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method humoral immune response to Shingrix week 12 (compared with baseline) proportion of patients with 4x fold increase in anti-gE antibody titer
- Secondary Outcome Measures
Name Time Method herpes zoster infection week 60 herpes zoster infection
Humoral immune response week 52 proportion of patients with 4x fold increase in anti-gE antibody titer
flares of underlying diseases week 26 and 60 disease flares
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
adverse events 4 weeks after injection unsolicited
Trial Locations
- Locations (1)
Department of Medicine, Tuen Mun Hospital
🇨🇳Hong Kong, China
Department of Medicine, Tuen Mun Hospital🇨🇳Hong Kong, China