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Virus Therapy

Recombinant Zoster Vaccine Administration and Testing for Chickenpox

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Event Reporting

Anti-glycoprotein E antibody Concentration

Secondary outcome measures

Acute Rejection Reporting

Glycoprotein E-Specific Cellular Responses

Other outcome measures

Exploratory Outcome

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)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,189,010 Total Patients Enrolled

Children's Hospital ColoradoOTHER

116 Previous Clinical Trials

5,132,495 Total Patients Enrolled

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,471 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I enroll in this trial?

"To become a participant in this trial, individuals must have recently experienced chickenpox and should be between the ages of 18-40. The estimated recruitment goal is 120 people."

Answered by AI

Is this clinical investigation recruiting participants presently?

"Data found on clinicaltrials.gov suggests that this trial is no longer actively recruiting patients, with the original posting date being December 5th 2023 and the last update occuring November 27th of the same year. Fortunately, other trials are still enrolling subjects at this time – 41 to be exact!"

Answered by AI

Does this experiment admit participants aged 35 and above?

"This clinical trial necessitates that patients are between 18 and 40 years old to be eligible. Eight separate trials exist for minors, while 32 other studies focus on seniors above the age of 65."

Answered by AI

Is the implementation of Recombinant Zoster Vaccine Administration and Testing safe for human subjects?

"Data suggests that Recombinant Zoster Vaccine Administration and Testing is safe, so it has been assigned a score of 3 on the 1-3 scale by Power. This treatment is already approved in Phase 4 trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Ravi Jhaveri 2023. "Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162494.

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