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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~530
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,319 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.
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