Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
- Conditions
- Herpes Zoster
- Interventions
- Biological: recombinant subunit herpes zoster vaccine
- 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
- Arm && Interventions
Group Intervention Description placebo recombinant subunit herpes zoster vaccine normal saline injection (0.5mL) vaccine recombinant subunit herpes zoster vaccine Shingrix vaccine
- 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 Humoral immune response week 52 proportion of patients with 4x fold increase in anti-gE antibody titer
herpes zoster infection week 60 herpes zoster infection
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