- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128189
Shingrix in Renal Transplant Recipients
June 2, 2023 updated by: University of Colorado, Denver
Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients.
Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix.
Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Herpes Zoster (HZ) is a common complication of kidney transplant because of the immune suppressive drugs necessary to prepare the recipient for the transplanted organ and to protect it from rejection.
The use of the live vaccine, Zostavax, in transplant recipients is contraindicated due to their impaired immune status.
This study is being done to determine vaccine responses to the FDA approved shingles vaccine, Shingrix, in patients with chronic renal failure eligible for kidney transplant.
Persistence of immune responses after kidney transplantation, and immunologic advantage of a third dose of Shingrix to renal transplant recipients will be assessed.
Additionally, safety, tolerability, and occurrence of HZ will be evaluated.
60 participants will be enrolled from the renal transplant services at University of Colorado Anschutz Medical Campus.
Study Type
Interventional
Enrollment (Estimated)
132
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ezra Moss, MPP
- Phone Number: 7207778815
- Email: ezra.moss@childrenscolorado.org
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Anschutz
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Contact:
- Ezra Moss, MPP
- Phone Number: 720-777-8815
- Email: ezra.moss@childrenscolorado.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- On the waiting list at the participating institutions for renal transplantation with anticipated transplantation to occur at > 3 months to 16 months after listing.
- Female subjects of non-childbearing potential (tubal ligation, hysterectomy,ovariectomy or post-menopausal
- Female subjects of childbearing potential who have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on day of vaccination, and have agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccine series
Exclusion Criteria:
- Therapy in the pre-transplant period that in the opinion of the investigator is immune suppressive
- Herpes Zoster in prior 3 years
- Herpes zoster vaccine or varicella vaccine within 3 years of study entry
- Any positive cPRA score prior to enrollment
- Acute illness at the time of vaccination which in the opinion of the investigator will alter immune response
- Any other active immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, HIV, or a medical therapy).
- Allergy to any of the components of Shingrix
- No investigational drugs from 30 days before enrollment or planned during the study.
- No non-live vaccines within the 2 weeks prior to any dose of Shingrix or until 30 days after any dose of Shingrix. No live virus vaccines within 4 weeks prior to any dose of Shingrix or until 30 days after any dose
- Pregnant or lactating female
- Multi-organ transplantation
- Travel time from study site that is more than 2 hours for visit or transport of fresh blood samples
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transplanted subject
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.
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Both arms receive standard 2 doses of Shingrix.
Transplanted subjects may receive 3rd dose.
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Sham Comparator: Non-Transplanted subject
Receives standard Shingrix dose (2), but not transplanted within 16 month time frame post-dose, so does not receive additional Shingrix dose.
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Both arms receive standard 2 doses of Shingrix.
Transplanted subjects may receive 3rd dose.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunology - Glycoprotein E(gE)-specific antibody and cell mediated immunity (CMI) will be measured.
Time Frame: 12 months after vaccination
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The kinetics and magnitude of antibody and CMI responses will be compared to immunologic data previously determined during studies of immune competent subjects.
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12 months after vaccination
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Safety information acquisition - Adverse events (AEs)
Time Frame: Adverse event data collected for 30 days after each vaccine dose.
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Safety and tolerability data about local and systemic adverse events will be collected via vaccine diaries.
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Adverse event data collected for 30 days after each vaccine dose.
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Ascertaining occurrence of HZ in vaccinees
Time Frame: At every contact from enrollment up to Month 36
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Subjects will be asked to notify study team and to complete an HZ questionnaire should they develop herpes zoster during the study.
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At every contact from enrollment up to Month 36
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Safety information acquisition - Serious Adverse Events (SAEs) and potential immune-mediated diseases (pIMDs)
Time Frame: SAEs and pIMD data collected from enrollment up to 12 months after Visit 4
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Subjects will be queried about SAEs and pIMDs at every contact.
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SAEs and pIMD data collected from enrollment up to 12 months after Visit 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunologic vaccine responses in patients with chronic renal failure
Time Frame: 1 month after 2nd dose of Shingrix.
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gE-Specific IL2 SFC/10; interleukin-2 = IL2, spot forming cells = SFC
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1 month after 2nd dose of Shingrix.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Myron J Levin, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-0005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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