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NCT Number: NCT06262776

Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

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. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens? 2. Are there differences in vaccination immunological responses between 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.

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Key information

Conditions

Immunosuppression Vaccine Response Impaired

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location status: Recruiting

Location contact

Patrick T Coates, PhD FRACP

CONTACT

[email protected]

+6170740000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Recombinant zoster vaccine adjuvanted (SHINGRIX)

Biological

2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.

Primary outcomes

  1. Functional T cell memory

    Time frame: 3 weeks following second vaccine dose

    ELISpot measurement of interferon gamma spot-forming units following 18-hour stimulation of peripheral blood mononuclear cells with Zoster gE protein-derived peptide array

Secondary outcomes

  1. Frequency of virus specific T cells

    Time frame: 3 weeks and 52 weeks following second vaccine dose

    Change in frequency of CD8+ Zoster gE protein-specific T cells identified by flow cytometry as CD8+CD134+CD69+ following 24-hour stimulation with a gE protein-derived peptide array

  2. Magnitude of antibody response

    Time frame: 3 weeks and 52 weeks following second vaccine dose

    Anti Varicella zoster gE Immunoglobulin M (IgM) and IgG antibody titres compared to baseline

  3. Concentration of post-vaccination circulating cytokines

    Time frame: 3 weeks following second vaccine dose

    Post-vaccination circulating cytokines compared to baseline

  4. Frequency of polyfunctional T cells

    Time frame: 3 weeks and 52 weeks following second vaccine dose

    Change in frequency of Zoster gE protein-specific polyfunctional T cells identified by flow cytometry intracellular cytokine staining (interferon-gamma, interleukin-2, tumour necrosis factor) following 24-hour stimulation with a gE protein-derived peptide array.

  5. Magnitude of vaccine-induced cross-protective antiviral responses

    Time frame: 3 weeks and 52 weeks following second vaccine dose

    T cells will be investigated for cross-protective herpesviridae responses using interferon gamma ELISpot compared to baseline following 24-hour stimulation with a gE protein-derived peptide array.

  6. Frequency of virus-specific T stem cell memory compared to baseline

    Time frame: 3 weeks and 52 weeks following second vaccine dose

    Frequency of Zoster gE protein-specific T stem cell memory (Tscm) will be determined by flow cytometry based on expression of T cell phenotypic markers (CD27+CD45RA+CD95+) on activation-induced marker-positive CD4 and CD8 T cells

Other outcomes

  1. Incidence of shingles

    Time frame: 12 months

    Incidence of shingles in the study cohort from 3 weeks post-vaccination to 12 month follow-up

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 12 months

    Safety of two-dose Zoster recombinant vaccine adjuvanted as measured by reported adverse events following immunisation using CTCAE v4.0 1 and 3 weeks after each vaccination, and 12 months after vaccination.

  3. Tolerability of vaccination regimen as assessed by EQ-5D

    Time frame: 3 weeks following second vaccine dose

    Tolerability of two-dose Zoster recombinant vaccine adjuvanted as measured by quality of life questionnaire EuroQol-5 dimensional (EQ-5D) questionnaire at baseline and 3 weeks after second vaccine dose. This questionnaire assesses quality of life rated on a scale of 0 (worst) to 100 (best), and assesses functional capacity rated on a scale of 0 (best) to 5 (worst) across 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Griffith B Perkins, PhD

CONTACT

[email protected]

70740000

Patrick T Coates, MBBS, FRACP, PhD

CONTACT

[email protected]

70740000

Sponsors and collaborators

Lead sponsor

Central Adelaide Local Health Network Incorporated

Other Gov

Collaborators

  • National Health and Medical Research Council, Australia
  • Royal Prince Alfred Hospital, Sydney, Australia
  • University of Adelaide

Registry information

Official study title

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

Acronym: SIR ZOSTER

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 16, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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