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SHINGRIX (herpes zoster vaccine, recombinant, adjuvanted) demonstrated >90% efficacy against shingles in all age groups 50 years of age and older, based on pooled data from two large, phase 3 randomised controlled trials.1-3

SHINGRIX efficacy against shingles in patients 50 years of age and older based on pooled data from two large, phase 3 randomised controlled trials.2,3

97% Efficacy Icon for ≥50

EFFICACY AGAINST SHINGLES IN ADULTS ≥50 YEARS

91% Efficacy Icon for ≥70

EFFICACY AGAINST SHINGLES IN ADULTS ≥70 YEARS

*In ZOE-50, VE against shingles was 97.2% in adults ≥50 years (SHINGRIX n/N: 6/7344; placebo n/N:210/7415). Median follow-up period of 3.1 years.1

†In a pooled analysis of VE against shingles ZOE-50 and ZOE-70 (SHINGRIX n/N: 25/8250); placebo n/N: 284/8346). Median follow-up of 4 years.1

Study designs

Study 1 design: Data from ZOE-50—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥50 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=7698) or placebo (N=7713). A total of 7344 and 7415 subjects who received SHINGRIX and placebo, respectively, were included in the modified Total Vaccinated Cohort (mTVC) analysis.1,2

Study 2 design: Data from ZOE-70—a placebo-controlled, observer-blind, phase 3 trial conducted in 18 countries in which subjects ≥70 years old were randomised to receive 2 doses (0 and 2 months) of either SHINGRIX (N=6950) or placebo (N=6950). A total of 6541 and 6622 subjects who received SHINGRIX and placebo, respectively, were included in the mTVC analysis.1,3

The modified vaccinated cohort (mTVC) - excluded participants who did not receive the second dose of recombinant zoster vaccine or placebo or who had a confirmed case of HZ within 1 month after the second dose.2,3

Pooled analysis: Data from ZOE-50 and ZOE-70 were combined in a prespecified pooled analysis. A total of 8250 and 8346 subjects ≥70 years of age who received SHINGRIX and placebo, respectively, were included.1-3 Exclusion criteria for these studies included subjects with a history of herpes zoster, subjects who had previously been vaccinated against varicella or herpes zoster and those with an immunosuppressive condition.2,3

SHINGRIX has provided sustained efficacy against HZ in adults 50 years of age or older up to 10 years and continues to be monitored.^^1-4

Shingles protection that lasts for up to year 104

ZOSTER-049 interim analysis

10 year efficacy graph for Shingrix 10 year efficacy graph for Shingrix

*Primary objective (descriptive analysis): VE against HZ over the ZOSTER-049 study. Follow-up period during interim analysis: ≥4 years in ZOSTER-049, until DLP - Mean 5.6 (±0.3) to 9.6 (±0.3) years post-vaccination in ZOE-50/70. HZ cases (n/N) in RZV group (52/7,277) and control group (283/7,277).4

†Secondary objective (descriptive analysis): VE against HZ from 1-month post-dose 2 in the ZOE-50/70 studies up to mean of 9.6 (±0.3) years post-vaccination. HZ cases (n/N) in RZV group (84/13,881) and control group (765/13,881).4

**No data are available for year 5 because that period corresponds to the gap between ZOE-50/70 and the Zoster-049 follow-up study.4,5

^Of the 14,648 ZOE-50/70 participants who received at least 1 RZV dose, 7,413 (50.6%) were enrolled in ZOSTER-049. Of these, 7,277 had previously received both RZV doses and were included in the mTVC for the efficacy assessments. In the absence of an unvaccinated placebo group for the LTFU study, the efficacy analyses in ZOSTER-049 used HC estimates from the ZOE-50/70 placebo groups recorded during the trials. At this DLP, data accrual was complete through year 9. Results for year 10 are also included although still incomplete, precision of estimates for this time point will increase at the final analysis.4,5

049 design: Interim analysis, subset of vaccines from parent ZOE studies, RZV versus matched HC from the placebo group in the ZOE-50/70 studies, adjusted for age and region at randomisation during the ZOE-50/70 studies.4,5 The same N and follow-up period were considered for the HC and vaccinated group.4 n for HC represents the projected number of included placebo group participants from ZOE-50/70 with at least one confirmed HZ episode based on the estimated incidence rate. RZV versus placebo recipients from the ZOE-50/70 trials, adjusted for region.4

Open-label, long term follow-up study of the pivotal phase 3 clinical trials (ZOE-50/70)4. 7,277 /14,648 of ZOE-50/70 received 2 doses of RZV and were included in the mTVC efficacy assessment.5 The study was initiated in April 2016, and the DLP for the second analysis was in August 2021, when participants had completed at least 4 additional years of follow-up.4 Total follow-up period varied between participants.5 Not all participants had reached Y10 post-vaccination at the DLP which is also presented.4-5

^^Shingrix was investigated in two large phase III clinical trials: ZOE-50 and ZOE-70. Shingrix demonstrated >90% vaccine efficacy against herpes zoster in all age groups ≥ 50 years of age based on data from ZOE-50 and pooled analysis from ZOE-50 and ZOE-70. 2,3

VIEW PHN EFFICACY DATA

Learn more about SHINGRIX

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Who can benefit from SHINGRIX?

There is a 1 in 3 lifetime risk of developing shingles.6,7 Age-related decline in immunity puts patients 50 years of age and older at an increased risk of developing shingles.7,8

View Patient Profiles

varicella zoster virus

Addressing age-related decline in immunity.

SHINGRIX – specifically formulated to help address age-related decline in varicella zoster virus specific immunity in adults 50 years of age and older.1,10,11

REVIEW SCIENTIFIC RATIONALE

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Learn more about the safety profile of SHINGRIX.

The majority of local and systemic adverse reactions were mild to moderate and transient, based on two large, phase 3 randomised controlled trials. Reactions reported as severe lasted 1 to 2 days.1-3

Explore safety data

References

  1. Shingrix, Summary of Product Characteristics (SPC), available on https://www.medicines.ie/medicines/shingrix-powder-and-suspension-for-suspension-for-injection-herpes-zoster-vaccine-recombinant-adjuvanted--35192/spc. Last Accessed: April 2023
  2. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang S-J, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May;372 (22):2087-96.
  3. Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang S-J, Diez-Domingo J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016 Sep;375 (11):1019-32.
  4. Strezova A, et al. Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years after Initial Vaccination. Open Forum Infect Dis. 2022; ofac485, https://doi.org/10.1093/ofid/ofac485.
  5. Boutry et al. The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase III Clinical Trials (ZOE-50 and ZOE-70). Clin Infect Dis. 2021 Jul 20;ciab629. doi: 10.1093/cid/ciab629.
  6. Harpaz R, et al. MMWR Recomm Rep. 2008 June;57(RR-5):1-30.
  7. Bollaerts K et al. A systematic review of varicella seroprevaience in European countries before universal childhood immunization: deriving incidence from seroprevaience data. Epidemiol. Infect. (2017), 145, 2666-2677.
  8. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-472.
  9. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356 (13):1338-43.
  10. Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JA, Richardus JH, 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 Mar;32 (15):1745-53.
  11. Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapelière P, Vassilev V, Ledent E, Heineman TC. A phase 1 /2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults. J Infect Dis. 2012 Oct;206 (8):1280-90.
  12. López-Fauqued M, et al. ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29. PMID: 30935742.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

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PM-IE-SGX-WCNT-220008 Date of Preparation: May 2023