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Virus Vaccine

Shingles Vaccine for Lupus

Phase 4

Recruiting

Led By Amit Saxena, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after last dose of hz/su vaccine (week 12 for vaccine, then placebo arm; week 36 for placebo, then vaccine arm)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will compare the safety and effectiveness of a new shingles vaccine in people with lupus to a placebo vaccine. The study will last for 24 weeks and involve people of different ages and with different levels of lupus activity.

Who is the study for?

This trial is for adults over 18 with Systemic Lupus Erythematosus (SLE) who meet specific criteria. Participants must not have had the shingles vaccine before, no recent shingles infection or severe SLE flares, and can't be on certain medications or have received other vaccines recently. Women in the study need to prevent pregnancy effectively.

What is being tested?

The trial tests the safety and immune response of a Herpes Zoster Subunit (HZ/su) Vaccine compared to a placebo in people with lupus. It's designed to see if getting vaccinated causes any significant lupus flare-ups within six months after vaccination.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at injection site, fatigue, headache, muscle pain, feverish feelings but also risks of triggering lupus flares due to immune system activation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after last dose of hz/su vaccine (week 12 for vaccine, then placebo arm; week 36 for placebo, then vaccine arm)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after last dose of hz/su vaccine (week 12 for vaccine, then placebo arm; week 36 for placebo, then vaccine arm)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after last dose of hz/su vaccine (week 12 for vaccine, then placebo arm; week 36 for placebo, then vaccine arm) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine

Secondary study objectives

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 24 Weeks after First Dose of HZ/su Vaccine

Levels of Serum Varicella-Zoster Virus Anti-Glycoprotein E Antibodies at 4 Weeks after Last Dose of HZ/su Vaccine

Occurrence of Grade 3 or Higher Adverse Events as Per CTCAE or Solicited AIT within 24 Weeks of First Dosing with HZ/su Vaccine

+5 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then HZ/su VaccineExperimental Treatment2 Interventions

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.

Group II: HZ/su Vaccine, then PlaceboExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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