Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients

Launched by CENTRAL ADELAIDE LOCAL HEALTH NETWORK INCORPORATED · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how well the SHINGRIX vaccine works for kidney transplant recipients compared to their healthy family members. It specifically looks at how different medication regimens, which these transplant patients are on to help prevent organ rejection, may affect their response to the vaccine. The researchers want to find out if these patients respond differently to the vaccine based on their specific medications and how their responses compare to those of healthy individuals living in the same household.

To participate in the study, you need to be over 18 years old and a kidney transplant recipient on one of three specific medication regimens, or a healthy household member over 50 years old who has had a previous infection with the Varicella zoster virus (which causes chickenpox). If you join the trial, you’ll receive two doses of the SHINGRIX vaccine and have your immune responses measured at various points from one week to one year after vaccination. This research is important because it may help improve vaccination strategies for transplant patients, who often have weaker immune systems.

Gender

ALL

Eligibility criteria

• 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