Post-Autologous Hematopoietic Stem Cell Transplant

Humoral and Cellular Immunogenicity of SHINGRIX in Post-Autologous Hematopoietic Stem Cell Transplant* Subjects

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

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

Data are from a descriptive analysis.


*NCT01610414.2

†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

auHSCT* [ZOSTER-002]

Phase and trial type/

Total vaccinated cohort

Phase 3

Randomized, observer-blind, placebo-controlled study.

N=1846 (TVC+)2.3
Patient Population

auHSCT recipients, ≥18 YOA, SHINGRIX (n=922), Placebo (n=924)3

  • Mean age 55 years
  • SHINGRIX: 18 to 49 YOA n=230 (24.9%), ≥50 YOA n=692 (75.1%)
  • Placebo: 18 to 49 YOA n=229 (24.8%), ≥50 YOA n=695 (75.2%)
Dosing Schedule 

2-dose series (0.5 mL each) administered 1 to 2 months apart, with the first dose given 50 to 70 days post-auHSCT3
Study Objectives

Vaccine efficacy, safety, and immunogenicity3

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.3,4

 

*NCT01610414.2

†Total vaccinated cohort included all participants who received at least 1 dose of SHINGRIX or placebo.3

 

auHSCT=autologous hematopoietic stem cell transplant; mL=milliliter; N=total number of patients included in the total vaccinated cohort; n=number of subjects in each group, SHINGRIX or placebo; TVC=total vaccinated cohort; YOA=years of age.

 

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

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