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Shingles Vaccine for Lupus
Study 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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: HZ/su Vaccine, then Placebo
- Group 2: Placebo, then HZ/su Vaccine
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Frequently Asked Questions
Are there any vacancies in this research endeavor open to potential participants?
"A glance at clinicaltrials.gov reveals that this medical experiment is not presently searching for participants, despite having first been posted on November 15th 2022 and most recently modified on September 26th 2022. Nevertheless, there are 154 other trials actively recruiting right now."
Are persons of any age eligible to be included in this scientific experiment?
"Eligibility for this study is restricted to those aged between 18 and 90. There are 25 studies available for minors, while 129 trials exist specifically targeting individuals who have exceeded the age of retirement."
Has this therapy obtained the necessary regulatory approval?
"The safety rating for this therapeutic intervention is a 3 due to the fact that this experiment has progressed through Phase 4, and therefore been approved by regulatory bodies."
How can I join the research protocol for this therapeutic trial?
"This trial is accepting 224 participants afflicted with lupus erythematosus, systemic who are between 18 and 90 years of age."
Who else is applying?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
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