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

NCT04748939 Phase 4 NOT_YET_RECRUITING

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

Details

Lead sponsor	Tuen Mun Hospital
Phase	Phase 4
Status	NOT_YET_RECRUITING
Enrolment	140
Start date	2025-01
Completion	2026-07

Conditions

• Herpes Zoster

Interventions

• recombinant subunit herpes zoster vaccine

Primary outcomes

• humoral immune response to Shingrix — week 12 (compared with baseline)
  proportion of patients with 4x fold increase in anti-gE antibody titer

Countries

China