NCT04516408

Recombinant Zoster Vaccine in Stable SLE Patients

Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 464 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and they account for about two-thirds of the events. And our previous study indicated that recent various VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Detailed description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. In addition, herpes zoster may trigger lupus flare. A case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Conditions

• Herpes Zoster
• Recombinant Zoster Vaccine
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant zoster vaccine	Recombinant zoster vaccine (RZV) is indicated for prevention of herpes zoster in adults aged ≥ 50 years old. RZV contains a varicella zoster virus glycoprotein E antigen and the AS01B adjuvant system.
BIOLOGICAL	Placebo	Sterilized water

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-08-18
• Last updated: 2022-10-26

Locations

1 site across 1 country: China