Mechanism of Action (MOA)

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,*

AGING IMMUNE SYSTEM

Age-related decline in immunity reduces the number and functionality of immune cells1,6-10

IMMUNE RESPONSE WITH SHINGRIX

The antigen gE and Adjuvant System AS01_B enhance VZV-specific immune response in a declining immune system1-3

VZV=varicella zoster virus.

*In a descriptive analysis of the pivotal clinical trials, the efficacy in preventing herpes zoster in adults ≥50 and ≥70 years of age was 93% and 85% respectively in the 4th year post vaccination.

Mechanism of Action Video

See how SHINGRIX helps address age-related decline in shingles immunity.1-3

You may also be interested in:

Efficacy

Only SHINGRIX delivered >90% efficacy against shingles regardless of age in those 50 years and older.11,†

Safety Profile

Learn about the results of 2 phase 3 clinical trials in which adverse reactions to SHINGRIX were studied.

CDC Recommendations

See what CDC says about SHINGRIX.

CDC=Centers for Disease Control and Prevention.

†Data from the phase 3 ZOE-50 (≥50 years of age) trial (median follow-up period 3.1 years) and pooled data in individuals ≥70 years of age from the phase 3 ZOE-50 and ZOE-70 trials (median follow-up period 4 years) in subjects who received 2 doses of SHINGRIX (n=7344 and 8250, respectively) or placebo (n=7415 and 8346, respectively). These populations represented the modified Total Vaccinated Cohort, defined as patients who received 2 doses (0 and 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of herpes zoster within 1 month after the second dose.11,12. See study designs on the Efficacy page for details.

Indication

Important Safety Information

Indication & Important Safety Info

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

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

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

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

SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.

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

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

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
Solicited local adverse reactions in subjects aged 50 years and older were pain (78.0%), redness (38.1%), and swelling (25.9%)
Solicited general adverse reactions in subjects aged 50 years and older were myalgia (44.7%), fatigue (44.5%), headache (37.7%), shivering (26.8%), fever (20.5%), and gastrointestinal symptoms (17.3%)
SHINGRIX was not studied in pregnant or lactating women, and it is unknown if it is excreted in human milk. Therefore, it cannot be established whether there is vaccine-associated risk with SHINGRIX in pregnant women or if there are effects on breastfed infants or milk production/excretion
Vaccination with SHINGRIX may not result in protection of all vaccine recipients

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. Levin MJ. Immune senescence and vaccines to prevent herpes zoster in older persons. Curr Opin Immunol. 2012;24(4):494-500. 7. Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR-5):1-30. 8. Kimberlin DW, Whitley RJ. Varicella–zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007;356(13):1338-1343. 9. Patterson-Bartlett J, Levin MJ, Lang N, Schödel 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. 10. 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. 11. Prescribing Information for SHINGRIX. 12. Data on file. Study 113077 (NCT01165229). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=113077

You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.

Trademarks are owned by or licensed to the GSK group of companies.

Top