Shingrix in Renal Transplant Recipients

NCT ID: NCT04128189

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2026-09-30

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.

Conditions

Kidney Transplant Recipient Response to Shingrix Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Shingrix

Intervention Type: BIOLOGICAL

Both arms receive standard 2 doses of Shingrix. Transplanted subjects may receive 3rd dose.

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.

Group Type: SHAM_COMPARATOR

Shingrix

Intervention Type: BIOLOGICAL

Both arms receive standard 2 doses of Shingrix. Transplanted subjects may receive 3rd dose.

Interventions

Shingrix

Both arms receive standard 2 doses of Shingrix. Transplanted subjects may receive 3rd dose.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myron J Levin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tori Rutherford, RN BSN

Role: CONTACT

tori.rutherford@childrenscolorado.org

303-724-2454

Facility Contacts

Tori Rutherford, RN BSN

Role: primary

tori.rutherford@childrenscolorado.org

303-724-2454

Other Identifiers

19-0005

Identifier Type: -

Identifier Source: org_study_id