Shingles Vaccine for Lupus
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, if you are taking rituximab or cyclophosphamide, you must not have received them within nine months of enrollment.
What data supports the effectiveness of the treatment Shingrix for preventing shingles in lupus patients?
Shingrix, a herpes zoster subunit vaccine, has shown excellent efficacy of about 90% in preventing shingles in adults aged 50 and older, with its effectiveness persisting for over three years. It is also considered safe and effective in immunocompromised patients, making it a promising option for lupus patients who are at increased risk of shingles.12345
Is the Shingrix vaccine safe for humans?
The Shingrix vaccine, also known as the herpes zoster subunit vaccine (HZ/su), has been shown to be generally safe in humans. Common side effects include mild to moderate pain, swelling, or redness at the injection site, as well as muscle pain and fatigue, which are usually temporary. It is not contraindicated for people with weakened immune systems and is preferred over live vaccines for these individuals.12356
How is the Shingrix vaccine different from other shingles treatments?
Shingrix is unique because it is a subunit vaccine, meaning it uses only a piece of the virus (glycoprotein E) combined with an adjuvant (a substance that enhances the body's immune response) to prevent shingles, unlike the older live attenuated vaccine which uses a weakened form of the virus. This makes Shingrix suitable for people with weakened immune systems, such as those with lupus, who cannot receive live vaccines.14678
What is the purpose of this trial?
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.
Research Team
Amit Saxena, MD
Principal Investigator
NYU Langone Health
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either HZ/su vaccine or placebo injection at week 0 and week 8
Treatment Period 2
Participants crossover to receive the alternate treatment (placebo or HZ/su vaccine) at week 24 and week 32
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Herpes Zoster Subunit (HZ/su) Vaccine
- Placebo
Herpes Zoster Subunit (HZ/su) Vaccine is already approved in United States, European Union, Canada for the following indications:
- Prevention of herpes zoster (shingles) in individuals 50 years and older
- Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years and older
- Prevention of herpes zoster (shingles) in individuals 50 years and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor