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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
140
vaccine administration
Department of Medicine, Tuen Mun Hospital
Hong Kong, China
humoral immune response to Shingrix
proportion of patients with 4x fold increase in anti-gE antibody titer
Time frame: week 12 (compared with baseline)
Humoral immune response
proportion of patients with 4x fold increase in anti-gE antibody titer
Time frame: week 52
adverse events
solicited
Time frame: 7 days after injection
adverse events
unsolicited
Time frame: 4 weeks after injection
flares of underlying diseases
disease flares
Time frame: week 26 and 60
herpes zoster infection
herpes zoster infection
Time frame: week 60
cell mediated response to vaccine
in 40 patients (20 from each arm); number of IFNγ-secreting CD4+ T cell colonies on ELISPOT assay
Time frame: week 12 from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.