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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
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)
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 moreTrial 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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,618 Total Patients Enrolled
Amit Saxena, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known immune system problem or am taking medication for cancer.I have received a shingles vaccine.I had shingles within the last year or during screening.I have not taken rituximab or cyclophosphamide in the last 9 months.My lupus symptoms have worsened since my last doctor's visit.I haven't received any vaccine, including COVID-19 shots, in the last six weeks.I am 18 years or older and can give informed consent.I am using birth control or do not need it due to surgery, menopause, or not having sex.I haven't taken any antibiotics or had a serious fever in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: HZ/su Vaccine, then Placebo
- Group 2: Placebo, then HZ/su Vaccine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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