Shingrix in Renal Transplant Recipients

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 3

Conditions: Kidney Transplant Recipient Response to Shingrix Vaccine

Treatments: Biological: Shingrix

Study type: Interventional

Funder types: Other

Identifiers

NCT04128189

19-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

132 participants in 2 patient groups

Transplanted subject

Active Comparator group

Description:

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.

Treatment:

Biological: Shingrix

Non-Transplanted subject

Sham Comparator group

Description:

Receives standard Shingrix dose (2), but not transplanted within 16 month time frame post-dose, so does not receive additional Shingrix dose.

Treatment:

Biological: Shingrix