Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients (SIR ZOSTER)

Central Adelaide Local Health Network (CALHN)

Status: Enrolling

Conditions: Vaccine Response Impaired; Immunosuppression

Treatments: Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX)

Study type: Interventional

Funder types: Other

Identifiers

NCT06262776

SIRZOSTER1.01

Details and patient eligibility

About

The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:

1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single organ kidney transplant recipient, currently receiving a specific immunosuppression regimen:

  1. Calcineurin inhibitor (tacrolimus or cyclosporine), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)
  2. Calcineurin inhibitor (tacrolimus or cyclosporine), mTOR inhibitor (sirolimus or everolimus), and oral steroid (n = 30)
  3. mTOR inhibitor (sirolimus or everolimus), antimetabolite (mycophenolate derivative or azathioprine), and oral steroid (n = 30)

• Aged >18 years

• estimated glomerular filtration rate (GFR) > 15 mL/min/1.73m2

• Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

OR

• Healthy household cohabitant of kidney transplant recipient enrolled in trial (n = 30)
• Aged > 50 years
• Previous documented infection with Varicella zoster (known infection history or positive Varicella zoster IgG result)

Exclusion criteria

• Unable or unwilling to provide informed consent to participate in the trial
• No previous infection with Varicella zoster (chickenpox)
• Known allergy to or intolerance of the contents of the SHINGRIX vaccine
• Current pregnancy
• For healthy household cohabitants, history of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Vaccination group

Experimental group

Description:

All participants will receive the assigned intervention, a 2-dose course of Zoster recombinant adjuvanted vaccine. Study participants will include kidney transplant recipients receiving specific immunosuppressive medications, and non-immunosuppressed household cohabitants, with comparisons made in magnitude of vaccine response.

Treatment:

Biological: Recombinant zoster vaccine adjuvanted (SHINGRIX)