Safety of the Herpes Zoster Subunit Vaccine in Lupus

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05559671
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Herpes Zoster Subunit (HZ/su) Vaccine — BIOLOGICAL
    Manufactured by GSK Biologicals SA. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.
  • Placebo — BIOLOGICAL
    Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Study Details

This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.

Key Dates

Start date
Dec 21, 2023
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HZ/su Vaccine, then Placebo
    During the initial 24-week period (Period 1), participants will receive HZ/su injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive placebo saline injection at week 24 and week 32.
  • Experimental: Placebo, then HZ/su Vaccine
    During the initial 24-week period (Period 1), participants will receive placebo saline injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive HZ/su injection at week 24 and week 32.

Primary Outcome Measure

Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine [ Time Frame: Up to Week 48 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Amit Saxena, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104
Cristina Arriens
[email protected]
405-271-7303

Find similar trials in New York, NY

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
NYU Langone Health· New York, NYOklahoma Medical Research Foundation· Oklahoma City, OK

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