Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

ConditionsImmunosuppression Vaccine Response Impaired

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentral Adelaide Local Health Network Incorporated

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Recombinant zoster vaccine adjuvanted (SHINGRIX)
Biological/Vaccine
2 doses of 0.5mL recombinant zoster vaccine adjuvanted intramuscular injection at week 0 and week 8.

Treatment groups

160 Participants

are divided into 1 treatment group

Group A: Vaccination groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Functional T cell memory

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

Time frame

3 weeks following second vaccine dose

Secondary outcomes

Frequency of virus specific T cells

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

Time frame

3 weeks and 52 weeks following second vaccine dose

Magnitude of antibody response

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

Time frame

3 weeks and 52 weeks following second vaccine dose

Concentration of post-vaccination circulating cytokines

Post-vaccination circulating cytokines compared to baseline

Time frame

3 weeks following second vaccine dose

Frequency of polyfunctional T cells

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.

Time frame

3 weeks and 52 weeks following second vaccine dose

Other outcomes

Incidence of shingles

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

Time frame

12 months

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

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.

Time frame

12 months

Tolerability of vaccination regimen as assessed by EQ-5D

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.

Time frame

3 weeks following second vaccine dose