MECHANISM OF ACTION

SHINGRIX is uniquely designed to overcome age-related decline in shingles immunity1-3

The 2-dose series of the recombinant antigen/adjuvant system formulation stimulates the immune system to generate a strong and sustained immune response.2,3,*
Image: SHINGRIX Mechanism of Action

  

  • *

    In a descriptive analysis of the pivotal clinical trials, the efficacy in preventing herpes zoster in adults ≥50 and ≥70 years old was 93% and 85%, respectively, in the fourth year post vaccination.

SHINGRIX and Aging

Immune response with and without SHINGRIX
Image: Aging immune system versus immune response with SHINGRIX

  

Watch how SHINGRIX works

Mechanism of Action

See how SHINGRIX helps address age-related decline in shingles immunity1-3
SHINGRIX mechanism of action videoVideo Icon
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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. Chlibek R, Smetana J, Pauksens K, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-1753.

  2. Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-2096.

  3. Bharucha T, Ming D, Breuer J. A critical appraisal of ‘Shingrix,’ a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017;13(8):1789-1797.

  4. Dendouga N, Fochesato M, Lockman L, Mossman S, Giannini SL. Cell-mediated immune responses to varicella-zoster virus glycoprotein E vaccine using both a TLR agonist and QS21 in mice. Vaccine. 2012;30(20):3126-3135.

  5. Leroux-Roels G, Marchant A, Levy J, et al. Impact of adjuvants on CD4+ T cell and B cell responses to a protein antigen vaccine: results from a phase II, randomized, multicenter trial. Clin Immunol. 2016;169:16-27.

  6. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30. 

  7. Kimberlin DW, Whitley RJ. Varicella–zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343.

  8. Weinberg A, Lazar AA, Zerbe GO, et al. Influence of age and nature of primary infection on varicella-zoster virus–specific cell-mediated immune responses. J Infect Dis. 2010;201(7):1024-1030. 

  9. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 

  10. Patterson-Bartlett J, Levin MJ, Lang N, Schõdel FP, Vessey R, Weinberg A. Phenotypic and functional characterization of ex vivo T cell responses to the live attenuated herpes zoster vaccine. Vaccine. 2007;25(41):7087-7093. 

  11. Prescribing Information for SHINGRIX.

  12. Didierlaurent AM, Laupèze B, Di Pasquale A, Hergli N, Collignon C, Garçon N. Adjuvant system AS01: helping to overcome the challenges of modern vaccines. Expert Rev Vaccines. 2017;16(1):55-63.

    Questions About SHINGRIX?

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