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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured one month following eh last dose of vaccine received
Awards & highlights
Study Summary
This trial will look at how well a vaccine works to protect people who had a stem cell transplant from getting sick.
Who is the study for?
This trial is for adults over 18 who are 1-3 years post-allogeneic stem cell transplant (AlloSCT) for various blood cancers. They must understand and sign consent, not be pregnant, and can have stable chronic graft-versus-host disease. Excluded are those with active primary cancer, acute illness at vaccination time, unsafe thrombocytopenia levels for injections, prior shingles after AlloSCT or allergies to Shingrix vaccine components.Check my eligibility
What is being tested?
The study tests the immune response effectiveness of the Shingrix vaccine in patients who've undergone an allogeneic stem cell transplant. It's a phase II trial designed to assess how well these patients' immune systems respond to this shingles vaccine.See study design
What are the potential side effects?
Shingrix may cause pain at the injection site, muscle pain, tiredness, headache, chills, fever or stomach discomfort. These side effects usually last only a few days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured one month following eh last dose of vaccine received
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured one month following eh last dose of vaccine received
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cell mediated and humoral immune response
Trial Design
1Treatment groups
Experimental Treatment
Group I: ShingrixExperimental Treatment1 Intervention
Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix
2019
Completed Phase 4
~500
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,834 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am undergoing a specific treatment plan.I had shingles after receiving a stem cell transplant from a donor.I am scheduled for a treatment to prevent immune system reactions.I have chronic graft-versus-host disease and am on a stable immunosuppression regimen.I have had a stem cell transplant from a donor.I am not pregnant.I had a stem cell transplant between 1 and 3 years ago.My blood cancer has come back after treatment.I am currently sick.I have a type of blood cancer.I have a low platelet count making injections risky.
Research Study Groups:
This trial has the following groups:- Group 1: Shingrix
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for volunteers to join the clinical trial currently?
"The trial, which was posted and last revised on March 7th 2023 according to clinicaltrials.gov, is presently recruiting individuals for participation in the study."
Answered by AI
How many individuals are being monitored as part of this clinical research?
"That is correct. According to clinicaltrials.gov, this experiment was posted on March 7th 2023 and has been recruiting up until now, with a total of 100 participants sought across one site."
Answered by AI
What sort of adverse effects should individuals be aware of when utilizing Shingrix?
"Taking into account the Phase 2 nature of this clinical trial, our team at Power have given Shingrix a safety score of 2. While there is some evidence that it could be safe to use, no data exists as yet confirming its efficacy."
Answered by AI
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