- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03993717
Solid Organ Transplant SHINGRIX
Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients
This study will assess the immune responses to the recombinant, AS01-adjuvanted varicella zoster virus subunit (HZ/su) vaccine or SHINGRIX in immunosuppressed patients, particularly those who have received a renal transplant, and aim to better understand if the vaccine and perhaps other adjuvanted vaccines are safe in these patients.
30 participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.The duration of the study is 180 days.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Shingles is a viral illness caused by the same virus that causes the chicken pox. Reactivation of this virus leads to shingles which is a painful blistering rash. Around 10% of organ transplant patients get shingles. This study will help us assess the safety and efficacy of a new shingles vaccine, SHINGRIX in Kidney Transplant patients. SHINGRIX is FDA approved for the prevention of shingles.
In this study, participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.
This research is conducted at the Emory University Hospital and Emory Clinics. Additionally follow up visits might also be conducted at the Emory Hope Clinic, the clinical arm of the Emory Vaccine Center.
Subjects will be identified through review of medical records or by referral from their healthcare providers. Subjects may also self-refer from the IRB approved recruitment flyers. Following identification/referral, a coordinator or recruiter will contact the subject and tell them about the study and see if he/she is interested. If the potential subject is interested, the recruiter will obtain an oral consent and prescreen them for the study using a screening checklist. Qualified subjects will be scheduled to come into the clinic and be fully consented and proceed with screening/enrollment.
Blood specimens will be collected and stored for the research study and for future use. Subjects can opt to have their information stored in a Hope Clinic database in order to contact them for other studies they may qualify for in the future. There are no other optional studies planned at this time.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30324
- Emory University Hospital
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Atlanta, Georgia, United States, 30030
- Hope Clinic
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Atlanta, Georgia, United States, 30322
- Emory University Hospital Clinical Research Network
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Atlanta, Georgia, United States, 30324
- Emory Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending study visits according to the study schedule
- Males or females greater than or equal to 50 years of age.
- Oral temperature less than 38 C.
- Are in general good health, as determined by medical history and targeted physical exam related to this history
- Recent renal transplant (either 3-6 months or 12-36 months prior)
- Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination
- Have received an ABO compatible allogeneic renal transplant
- Male subjects should agree not to contribute to conception of a child, including sperm donation, for the duration of the study.
Exclusion Criteria:
- Have received any transplant in addition to renal transplant
- Have an acute illness within 72 hours prior to vaccination
- Have a severe medical condition as determined by the investigators
- Have kidney disease related to any known immune/autoimmune phenomena including, but not limited to: systemic lupus erythematosus, glomerulonephritis (post-streptococcal, Goodpasture syndrome, granulomatosis with polyangitis, polyarteritis nodosa, etc.).
- Be on systemic immunosuppressive agents aside from those related to their renal transplant
- Have known HIV or primary immune deficiency
- Have a known potential immune-mediated disorder (pIMD)
- Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation
- Have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
- Have donated blood or blood products within 56 days before study vaccination and for the duration of the study
- Have received the Shingrix or Zostavax injection previously
- Have had Shingles in the past
- Be of child-bearing potential
- Have known recent exposure to wild-type varicella in the past 4 weeks
- Have a history of severe reactions following other vaccinations
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Three to six months post-transplant Group
Subjects in this arm will receive the SHINGRIX vaccine three to six months after kidney transplant
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A single intramuscular injection of the FDA-approved recombinant glycoprotein E herpes zoster (HZ/su) vaccine will be administered in the deltoid muscle of the preferred arm
Other Names:
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Twelve to thirty-six months post-transplant Group
Subjects in this arm will receive the SHINGRIX vaccine twelve to thirty-six months after kidney transplant
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A single intramuscular injection of the FDA-approved recombinant glycoprotein E herpes zoster (HZ/su) vaccine will be administered in the deltoid muscle of the preferred arm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in levels of Anti-gE antibody concentrations
Time Frame: Day 1, Day 61, Day 180
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Anti-gE antibody concentrations will be obtained via enzyme-linked immunosorbent assay (ELISA)
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Day 1, Day 61, Day 180
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Change in number of subjects with a vaccine response for anti-gE antibody
Time Frame: Day 61, Day 180
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Vaccine response is defined as:
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Day 61, Day 180
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with any related severe adverse events (SAEs)
Time Frame: Day 180
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Number of participants with SAEs from first vaccination until the end of the trial
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Day 180
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Number of subjects with any grade 3 related adverse events (AEs)
Time Frame: Day 91
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Number of subjects with any grade 3 related AEs from each vaccination and until 15 days after each vaccination
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Day 91
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Number of subjects with renal allograft rejection
Time Frame: Day 180
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Number of subjects with renal allograft rejection from first vaccination until the end of the trial
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Day 180
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Number of subjects with changes in allograft function
Time Frame: Day 180
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Number of subjects with changes in allograft function from first vaccination until the end of the trial. Allograft function will be defined as increase in serum creatinine levels (≥ 1.25, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase) |
Day 180
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Change in HLA antibody titers
Time Frame: Day 1, Day 15, Day 61, Day 75, Day 180
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HLA antibody titers will be measured and analyzed at different time points
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Day 1, Day 15, Day 61, Day 75, Day 180
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadine Rouphael, MD, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00109207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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Clinical Trials on SHINGRIX
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National Institute of Allergy and Infectious Diseases...Recruiting
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University of WashingtonNational Institute on Aging (NIA)RecruitingVaricella Zoster Virus InfectionUnited States
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Loyola UniversityNot yet recruiting
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University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID)Completed
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Seoul National University HospitalRecruitingSystemic Lupus Erythematosus | Vaccine Reaction | ZosterKorea, Republic of
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Emory UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Completed
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University of Colorado, DenverGlaxoSmithKlineRecruitingStem Cell Transplant | Bone Marrow TransplantUnited States
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Immorna Biotherapeutics, Inc.ICON plcActive, not recruitingInfectious Disease | Shingles | Herpes Zoster (HZ)United States
-
ModernaTX, Inc.Active, not recruitingHerpes ZosterUnited States, Puerto Rico