Post-Renal Transplant

Humoral and Cellular Immunogenicity of SHINGRIX in Post-Renal Transplant Patients

A measure of the immune response that confers protection against herpes zoster is unknown.

Post-Renal Transplant Humoral Immunogenicity Anti-gE Antibody GMCs infographic
Post-Renal Transplant Cellular Immunogenicity Median frequency for gE-specific CD4+ T-cells infographic
Post-Renal Transplant Humoral Immunogenicity Anti-gE Antibody GMCs infographic
Post-Renal Transplant Cellular Immunogenicity Median frequency for gE-specific CD4+ T-cells infographic

Data are from a descriptive analysis.


*Error bars indicate 95% Cl.

 

†Error bars represent 1st and 3rd IQR.

 

ATP=according to protocol; gE=glycoprotein E; GMC=geometric mean concentration; IQR=interquartile range; M=month; mlU=milli-international units; mL=milliliter.

Study Design

 Study

RENAL TRANSPLANT [ZOSTER-041]

Phase and trial type/

Total vaccinated cohort 

Phase 3

Randomized, observer-blind, placebo-controlled study.

N=264 (TVC*)2
Patient Population

ABO-compatible allogeneic renal transplant recipients, ≥18 YOA, SHINGRIX (n=132), Placebo (n=132)2

 

  • Mean age 52.4 [SD±12.6]
  • Receiving maintenance immunosuppressive therapy for allograft rejection
  • Stable renal function
Dosing Schedule 

2-dose series (0.5 mL each) administered 1 to 2 months

apart, given 4 to 18 months post-transplant2 
Study Objectives 

Evaluation of immunogenicity and safety2

Patients were excluded if they were vaccinated against herpes zoster or varicella zoster virus within the 12 months preceding the first dose of study vaccine/placebo or had a clinical history of varicella or herpes zoster within the 12 months preceding the first dose of study vaccine/placebo.2

 

*Total vaccinated cohort included all participants who received at least 1 dose of SHINGRIX or placebo.2

 

mL=milliliter; N=total number of patients included in the total vaccinated cohort; n=number of subjects in each group, SHINGRIX or placebo; SD=standard deviation; TVC=total vaccinated cohort; YOA=years of age.

 

The above is not the full list of inclusion or exclusion criteria.

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