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Vaccine

Shingrix Vaccine for Kidney Transplant Recipients

Phase 3
Recruiting
Led By Myron J Levin, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at every contact from enrollment up to month 36
Awards & highlights

Study Summary

This trial evaluates the safety and response of Shingrix vaccine in kidney transplant recipients. People on the waiting list may get 2 doses, and those who have had a transplant may get 3.

Who is the study for?
This trial is for adults on the kidney transplant waiting list, expected to receive a transplant within 3-16 months. Women must use contraception and have a negative pregnancy test before vaccination. Excluded are those with recent herpes vaccines, positive cPRA scores, other vaccine or drug conflicts, travel constraints, immune suppression not related to transplantation, multi-organ transplants or acute illness.Check my eligibility
What is being tested?
The Shingrix vaccine's safety and effectiveness in prompting an immune response are being tested in kidney transplant recipients. Participants will get the standard two doses of Shingrix while on the waiting list; if they've been transplanted by 16 months post-listing, they may receive a third dose.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects of Shingrix can include pain at injection site, muscle pain, tiredness, headache and shivering.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at every contact from enrollment up to month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and at every contact from enrollment up to month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ascertaining occurrence of HZ in vaccinees
Immunology - Glycoprotein E(gE)-specific antibody and cell mediated immunity (CMI) will be measured.
Safety information acquisition - Adverse events (AEs)
+1 more
Secondary outcome measures
Immunologic vaccine responses in patients with chronic renal failure

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Transplanted subjectActive Control1 Intervention
In addition to receiving standard dose (2) of Shingrix prior to transplantation, participant may receive a 3rd dose several months after transplantation if they meet criteria related to no rejection.
Group II: Non-Transplanted subjectPlacebo Group1 Intervention
Receives standard Shingrix dose (2), but not transplanted within 16 month time frame post-dose, so does not receive additional Shingrix dose.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,416 Total Patients Enrolled
Myron J Levin, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

Shingrix (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04128189 — Phase 3

Frequently Asked Questions

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

Has the Transplanted subject been granted sanction by the FDA?

"The safety of the transplanted subject is judged to be 3 on a scale from 1 to 3, as this clinical trial is in its third phase. This indicates that there are both efficacy data and multiple rounds of supportive evidence for safety."

Answered by AI

Does the clinical trial accept participants aged seventy and older?

"This clinical trial is open to individuals who are in the 18-70 year old age range."

Answered by AI

Are there any available slots for volunteers to participate in this clinical research?

"The clinical trial is actively recruiting volunteers, as indicated by the latest information hosted on clinicaltrials.gov and edited most recently on March 2nd 2023 - since it was first posted a month prior."

Answered by AI

What is the enrollment criterion for this medical trial?

"Affirmative. According to clinicaltrials.gov, this research study is actively seeking out participants and was first posted on March 1st 2023 with its most recent update occurring a day later. 132 people are needed in total from 1 site of recruitment."

Answered by AI

Has this type of clinical trial ever been attempted before?

"Currently, 15 active clinical trials related to Transplanted subject are being conducted in 91 cities and 23 countries. The first such trial, sponsored by Bristol-Myers Squibb, was launched in 2014 with 130 participants and ultimately earned Phase 2 drug approval. Afterwards 28 more studies concluded succesfully."

Answered by AI

Who are the eligible participants for this research endeavor?

"This clinical trial will be evaluating the kidney transplant recipient response to shingrix vaccine for 132 participants between 18-70 years of age. To qualify, subjects must have been on a renal transplant waiting list with an anticipated procedure date > 3 and < 16 months post listing. Additionally, female candidates must either demonstrate non-childbearing potential or pledge to use adequate contraception before and after vaccination during the entire treatment period and two months following completion of their vaccine series while also taking pregnancy tests prior to receiving any injections."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Shingrix in Renal Transplant Recipients
2023. "Shingrix in Renal Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04128189.
~63 spots leftby Apr 2025
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