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Tests treatment safety and results for Immunosuppression
Official title Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients
ClinicalTrials.gov ID: NCT06262776
What this study is testing
What is Recombinant zoster vaccine adjuvanted (SHINGRIX)?
Recombinant zoster vaccine adjuvanted (SHINGRIX) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for immunosuppression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Population - Group 1. Healthy co-habitants (n = 30)
- Household co-habitant of transplant recipient in trial
- Aged \>50 years
- Previous documented infection with VZV (known infection history or positive VZV IgG result)
You likely can't join if
- 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
- Population - Groups 2-4. Transplant recipients (n = 90) Inclusion criteria:
See the full eligibility criteria
- Population - Group 1. Healthy co-habitants (n = 30)
- Household co-habitant of transplant recipient in trial
- Aged \>50 years
- Previous documented infection with VZV (known infection history or positive VZV IgG result)
- 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
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.