Comparing vaccine responses in kidney transplant patients and their healthy cohabitants

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

This study is testing how well the shingles vaccine works in kidney transplant patients on different medications compared to their healthy family members.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Adelaide Local Health Network Incorporated (Government)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06262776 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the immunological responses to the Varicella Zoster vaccination in kidney transplant recipients who are on different immunosuppression regimens, as well as in their healthy cohabitants. Participants will receive a two-dose course of the SHINGRIX recombinant Zoster vaccine, with immunological responses measured at five time points from one week to one year post-vaccination. The study seeks to determine if there are significant differences in vaccine responses based on the type of immunosuppression and between transplant patients and healthy individuals.

Who should consider this trial

Good fit: Ideal candidates include kidney transplant recipients aged over 18 years on specific immunosuppression regimens or healthy household cohabitants aged over 50 years with a history of Varicella zoster infection.

Not a fit: Patients who are not kidney transplant recipients or healthy cohabitants without a documented history of Varicella zoster infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccination strategies for kidney transplant recipients, improving their protection against Varicella Zoster.

How similar studies have performed: Other studies have shown varying success in vaccine responses among immunocompromised populations, but this specific approach is relatively novel.

Eligibility criteria

1. Population - Group 1. Healthy co-habitants (n = 30)

   Inclusion criteria:
   * Household co-habitant of transplant recipient in trial
   * Aged \>50 years
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<50 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * No previous infection with VZV (chickenpox)
   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
2. Population - Groups 2-4. Transplant recipients (n = 90)

   Inclusion criteria:
   * Organ transplant recipients

     \-- Specific immunosuppression regimen
     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)
     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)
     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)
   * Aged \>18 years
   * estimated GFR \> 15 mL/min/1.73m2
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<18 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * No previous infection with VZV (chickenpox)
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * Current pregnancy
3. Population - Group 5. Other (n = 10)

   Inclusion criteria:
   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression
   * Aged \>18 years
   * Previous documented infection with VZV (known infection history or positive VZV IgG result)

   Exclusion criteria:
   * Aged \<18 years
   * Unable or unwilling to provide informed consent to participate in the trial
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * No previous infection with VZV (chickenpox)
   * Known allergy to or intolerance of the contents of the RZV vaccine
   * Current pregnancy
   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy
4. Population - Group 6. Dialysis group (n = 30)

Inclusion criteria:

* Kidney failure receiving haemodialysis as kidney replacement therapy
* Aged \>18 years
* Previous documented infection with VZV (known infection history or positive VZV IgG result)

Exclusion criteria:

* Aged \<18 years
* Unable or unwilling to provide informed consent to participate in the trial
* Known allergy to or intolerance of the contents of the RZV vaccine
* No previous infection with VZV (chickenpox)
* Known allergy to or intolerance of the contents of the RZV vaccine
* Current pregnancy
* History of primary immunodeficiency or active immunosuppressive therapy

Where this trial is running

Adelaide, South Australia

• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Principal investigator: Patrick T Coates, FRACP — Central and Northern Adelaide Renal and Transplantation Services
• Study coordinator: Patrick T Coates, MBBS, FRACP, PhD

Conditions Immunosuppression; Vaccine Response Impaired