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Herpes Zoster Vaccine for Shingles
Study Summary
This trial will study the long-term effects of a herpes zoster vaccine, given either as a primary course or as a booster. It will also assess the safety of the vaccine up to seven years after vaccination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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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- I will not receive a live vaccine 30 days before or after the study vaccine doses.I haven't had a transplant rejection in the last 3 months.I am a woman who cannot become pregnant due to medical reasons.I plan to or have received a vaccine not part of the study within 8 days before or 30 days after getting the study vaccine.I had shingles within the last year.I haven't received immunoglobulins or blood products 3 months before or won't until 26 months after the first study vaccine dose.I am not planning to become pregnant or stop using birth control for 2 months after my second vaccine dose.I completed the 2-dose HZ/su vaccine course in the ZOSTER-041 study.I can follow the study's requirements or have someone who can ensure I do.I am a woman who can have children, used birth control for 30 days, tested negative for pregnancy today, and will continue birth control for 2 months after getting revaccinated.I have a condition that weakens my immune system.I haven't used B-cell antibodies for transplant rejection within 9 months.I have been vaccinated against shingles after completing study ZOSTER-041.I have had more than one organ transplant.I have been on CIS therapy to prevent organ rejection for at least a month.
- Group 1: HZ/su Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are the goals of this research?
"The purpose of this study is to observe the anti-gE antibody concentrations at Month 12, with follow up evaluations at Month 24. Additionally, this study will secondary monitor for allograft dysfunction related to rejection or HZ episodes in the Revaccination active and follow-up phases respectively. Lastly, another goal is to percentage of subjects with any SAE in the Revaccination active phase."
To your knowledge, has anything like this been attempted before?
"HZ/su vaccine (GSK1437173A) has been tested in clinical trials since 2014. The first study, sponsored by Bristol-Myers Squibb, had 130 participants and was completed that same year. After the initial research was published, HZ/su vaccine (GSK1437173A) received Phase 2 drug approval. As of now, there are 16 active global trials involving this medication taking place in 92 cities across 23 countries."
How many people are subjects in this experiment?
"Right now, this trial is not enrolling new patients. The listing was created on December 9th, 2019 and edited most recently on November 14th, 2022. If you're looking for other studies to participate in, there are 49 herpes zoster trials and 16 HZ/su vaccine (GSK1437173A) studies that are still recruiting patients."
Could you list the side effects of GSK1437173A for us?
"This HZ/su vaccine (GSK1437173A) is in Phase 3 clinical trials, so there is some evidence of its efficacy and it has been studied for safety multiple times, giving it a score of 3."
Is GSK1437173A the only medication used in this trial?
"To date, there are 16 ongoing clinical trials evaluating the efficacy of HZ/su vaccine (GSK1437173A). 4 of these studies have reached Phase 3. The majority of research on HZ/su vaccine (GSK1437173A) is conducted in Madison, Wisconsin; however, there are a total of 207 locations where this investigation is taking place."
Are patients currently being enrolled in this clinical trial?
"This study is not recruiting at the moment. The listing was posted on December 9th, 2019 and updated on November 14th, 2020. For those still interested in participating in clinical trials, there are 49 active studies for herpes zoster and 16 HZ/su vaccine (GSK1437173A) trials currently looking for patients."
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