← Back to Search

Virus Therapy

Zoster Vaccine for Shingles

Phase 4
Waitlist Available
Led By Ravi Jhaveri, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable immunosuppressive medication regimen for last 6 months prior to participation
Be between 18 and 65 years old
Must not have
Febrile illness with Temp ≥39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1
Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new vaccine in organ transplant recipients to prevent the virus that causes shingles.

Who is the study for?
This trial is for young adults who have had a solid organ transplant over a year ago, are on stable immunosuppressive meds for the last 6 months, and can follow up via phone or online. It's not for those with recent vaccine shots, shingles history, current pregnancy, fevers above 39°C, infections needing hospital care or drugs within two weeks before starting.
What is being tested?
The study tests the safety and immune response to the recombinant zoster vaccine in these patients. They'll get vaccinated and then be checked for any negative reactions and their body's defense against shingles will be measured.
What are the potential side effects?
Possible side effects from the recombinant zoster vaccine may include redness or pain at injection site, headache, muscle pain, fatigue, feverish feelings but exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My immunosuppressive medication has not changed in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had a fever of 39°C or higher or needed antibiotics in the last 14 days.
Select...
I am currently taking steroids or other drugs to suppress my immune system.
Select...
I have had more than 2 treatments for acute rejection in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Event Reporting
Anti-glycoprotein E antibody Concentration
Secondary study objectives
Acute Rejection Reporting
Glycoprotein E-Specific Cellular Responses
Other study objectives
Exploratory Outcome

Awards & Highlights

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.
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: Recombinant Zoster Vaccine Administration and TestingExperimental Treatment1 Intervention
all participants will receive 2 doses of recombinant zoster vaccine (Shingrix)

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
267 Previous Clinical Trials
5,181,672 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,133,071 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
837 Previous Clinical Trials
6,565,217 Total Patients Enrolled
~80 spots leftby Mar 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top