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Virus Vaccine

Shingrix Vaccine for Shingles

Phase 2
Recruiting
Research Sponsored by Loyola University
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 4 trial • 105 Patients • NCT04169009
11%
Body aches
6%
dizziness
6%
shaking chills
3%
Injection site pain
3%
Lymphedema
3%
decreased range of motion LUE
3%
fever
3%
felt feverish
3%
nausea and vomiting
3%
Worsening back pain
3%
malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
No Previous ZVL (Cohort 4)
ZVL >5 Years Previously (Cohort 1)
SRX >5 Years Previously (Cohort 2)
ZVL 6-12 Months Previously (Cohort 3)

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
~600

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,356 Total Patients Enrolled

Media Library

Shingrix (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05554068 — Phase 2
Shingles Research Study Groups: Shingrix
Shingles Clinical Trial 2023: Shingrix Highlights & Side Effects. Trial Name: NCT05554068 — Phase 2
Shingrix (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554068 — Phase 2
~8 spots leftby Mar 2025
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