Human Immunodeficiency Virus

Humoral and Cellular Immunogenicity of SHINGRIX in Human Immunodeficiency Virus Patients

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

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

Data are from a descriptive analysis.

*Dosing in the HIV study was 3 doses at 0, 2, and 6 months; however, administration of the third dose of SHINGRIX is outside the approved dosing schedule for SHINGRIX.2,3

Data post-3rd dose are not given

†Error bars indicate 95% Cl.

‡Error bars represent 1st and 3rd IQR.

 

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

 

Study Design

 Study

HIV [ZOSTER-015]

Phase and trial type/ 

Total vaccinated cohort 

Phase 1/2a 

Randomized, observer-blind, placebo-controlled study. 

N=123 (TVC*)2
Patient Population

HIV patients ≥18 YOA, mean age 46.0 [SD±10.93] 

SHINGRIX (n=74), Placebo (n=49), with the following ART status2:

 

SHINGRIX: 

  • ART-treated ≥200 CD4+ T cells/mm3 (n=56)
  • ART-treated 50–199 CD4+ T cells/mm3 (n=9)
  • ART-naive ≥500 CD4+ T cells/mm3 (n=9) 
Placebo:
  • ART-treated ≥200 CD4+ T cells/mm3 (n=38)
  • ART-treated 50–199 CD4+ T cells/mm3 (n=5)
  • ART-naive ≥500 CD4+ T cells/mm3 (n=6) 
Dosing Schedule 

Patients were administered SHINGRIX or placebo (0.5 mL each) on a 0-, 2-, and 6-month schedule; however, administration of the third dose of SHINGRIX is outside of the approved dosing schedule for SHINGRIX.2,3 Data regarding immunogenicity post-dose 3 are not presented. 

 
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.4

 

ART=antiretroviral treatment; HIV=human immunodeficiency virus; mL=milliliter; mm=millimeter; N=total number of patients included in the total vaccinated cohort; n=number of subjects in each group, SHINGRIX or placebo; YOA=years of age.

 

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

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