Clinical trial NCT04128189: Shingrix in Renal Transplant Recipients
Official title: Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Kidney Transplant Recipient Response to Shingrix Vaccine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunology - Glycoprotein E(gE)-specific antibody and cell mediated immunity (CMI) will be measured.
timeFrame: 12 months after vaccination
measure: Safety information acquisition - Adverse events (AEs)
timeFrame: Adverse event data collected for 30 days after each vaccine dose.
measure: Ascertaining occurrence of HZ in vaccinees
timeFrame: At every contact from enrollment up to Month 36
measure: Safety information acquisition - Serious Adverse Events (SAEs) and potential immune-mediated diseases (pIMDs)
timeFrame: SAEs and pIMD data collected from enrollment up to 12 months after Visit 4
Secondary outcomes:
measure: Immunologic vaccine responses in patients with chronic renal failure
timeFrame: 1 month after 2nd dose of Shingrix.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Myron J Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: