Solid Tumor Malignancy

Humoral and Cellular Immunogenicity of SHINGRIX in Solid Tumor Malignancy Subjects

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

Solid Tumor Malignancies Humoral Immunogenicity Anti-gE Antibody GMCs infographic
Solid Tumor Malignancies Cellular Immunogenicity Median frequency for gE-specific CD4+ T-cells infographic
Solid Tumor Malignancies Humoral Immunogenicity Anti-gE Antibody GMCs infographic
Solid Tumor Malignancies Cellular Immunogenicity Median frequency for gE-specific CD4+ T-cells infographic

Data are from a descriptive analysis.


*Error bars indicate 95% Cl.

 

†Cellular immunogenicity data from the PreChemo group only.2

 

‡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

SOLID TUMOR MALIGNANCIES [ZOSTER-028]

Phase and trial type/ 

Total vaccinated cohort

Phase 2/3

Randomized, observer-blind, placebo-controlled study.

N=232 (TVC*)2
Patient Population

Patients with solid tumors who were receiving cytotoxic or immunosuppressive chemotherapy, ≥18 YOA, SHINGRIX (n=117), Placebo (n=115)2

  • Mean age 57.8 [SD±11.3]
  • Dose 1 given either 8 to 30 days before the start of a cycle (PreChemo group) or within 1 day of the start of a cycle (OnChemo group)
  • The majority of patients were in the PreChemo group
Dosing Schedule

2-dose series (0.5 mL each) administered 1 to 2 months apart, with the first dose given either prior to or at the start of a chemotherapy cycle;

Dose 2 given with a subsequent cycle2
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.1

 

*Total vaccinated cohort included all participants who received at least 1 vaccine dose.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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