HUMAN IMMUNODEFICIENCY VIRUS

Humoral and Cellular Immunogenicity of SHINGRIX in Patients with Human Immunodeficiency Virus

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

Humoral Immunogenicity
Anti-gE Antibody GMCs1,*,†
(ATP Cohort for Immunogenicity)

Descriptive analysis.

HIV Humoral Immunogenicity Anti-gE Antibody GMCs infographic

Cellular Immunogenicity
Median frequency for gE-specific CD4+ T-cells1,*,‡
(ATP Cohort for Immunogenicity)

Descriptive analysis.

HIV Cellular Immunogenicity Median frequency for gE-specific CD4+ T-cells graph
  • *

    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

Patients with HIV ≥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 0.5mL of either SHINGRIX or placebo 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

  •  

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

  •  
  • *

    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.

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Indication & Important Safety Info

Indication

Important Safety Information

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

  • in adults aged 50 years and older.
  • in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

  • SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
  • Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
  • In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
  • Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
  • Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)  
  • Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)  
  • Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
  • The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
  • It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
  • Vaccination with SHINGRIX may not result in protection of all vaccine recipients

 

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at https://gsk.public.reportum.com or
1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. Berkowitz EM, Moyle G, Stellbrink HJ. J Infect Dis. 2015;211(suppl):1-14. doi:10.1093/infdis/jiu606
  2. Berkowitz EM, Moyle G, Stellbrink HJ. J Infect Dis. 2015;211:1279-1287.
  3. Prescribing Information for SHINGRIX.
  4. Data on file. Study 112673 (NCT01165203). GSK Study Register. Study entry at https://www.gsk-studyregister.com/en/trial-details/?id=112673

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