Zoster vaccine recombinant, adjuvanted

(Shingrix®)

Shingrix®

Drug updated on 11/5/2024

Dosage FormInjection (intramuscular; 50 mcg/0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for prevention of herpes zoster (HZ) (shingles) in adults aged 50 years and older, and 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.

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Summary
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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-12]
  • Herpes zoster (HZ) incidence reduced significantly in high-risk populations (140 fewer per 1000), with a minor reduction in healthy populations (28 fewer per 1000). Vaccine efficacy in immunocompetent adults was 94% (≥50 years) and 91.3% (≥70 years); in immunocompromised HSCT (haematopoietic stem cell transplantation) patients, it was 68.2%. For diabetes patients, live-attenuated zoster vaccine (LZV) had 48% effectiveness, and recombinant zoster vaccine (RZV) had 91% efficacy.
  • Postherpetic neuralgia (PHN) showed no significant difference in most populations. Vaccine efficacy against PHN was 91.2% in adults ≥50 years, 88.8% in adults ≥70 years, and 89.3% in HSCT patients.
  • Herpes zoster vaccination was associated with a reduced risk of dementia, with a pooled odds ratio of 0.84.
  • Humoral immune response rate for anti-gE was 95.2% one month after RZV dose 2, decreasing to 77.6% during immunosuppression, while cell-mediated immunity response was 84.6%.
  • Adverse events, primarily related to injection-site and systemic reactions such as pain and fatigue, were common across healthy and high-risk populations receiving RZV, though they did not significantly affect second-dose compliance. Serious adverse events (SAEs) were comparable between RZV and placebo groups.
  • In immunocompromised adults aged 18-49 years, SAEs were reported in 8.1% to 30.8% of RZV recipients and 4.1% to 36.5% of placebo recipients, with SAEs related to vaccination occurring in less than 1% in both groups.
  • Compared to ZVL, RZV-associated adverse events were mainly mild to moderate, with no increased risk of SAEs or death, and no notable differences in adverse event incidence between immunosuppressed and non-immunosuppressed groups.
  • RZV demonstrates high effectiveness across various populations, including a 91% efficacy in adults with diabetes, high efficacy in older adults (94% for those ≥50 years, 91.3% for those ≥70 years), and 68.2% efficacy in immunocompromised patients post-HSCT; it also shows significant efficacy in CKD and autoimmune disease populations without increased adverse events, with effectiveness waning more rapidly in the very elderly.

Product Monograph / Prescribing Information

Document TitleYearSource
Shingrix (zoster vaccine recombinant, adjuvanted) Prescribing Information.2023GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effectiveness and safety of the recombinant herpes zoster vaccine in different population groups: a systematic review and meta-analysis2024Medicina
Immunogenicity of Recombinant Zoster Vaccine: A Systematic Review, Meta-Analysis, and Meta-Regression2024Vaccines
Herpes zoster vaccination and the risk of dementia: A systematic review and meta-analysis2024Brain And Behavior
Differential Utility Losses in Herpes Zoster Cases Between Vaccinated and Unvaccinated Subjects: A Meta-analysis of Three Clinical Trials2024Clinical Drug Investigation
Efficacy and safety of the recombinant zoster vaccine: A systematic review and meta-analysis2023Vaccine: X
Efficacy and effectiveness of Herpes zoster vaccination in adults with diabetes mellitus: a systematic review and meta-analysis of clinical trials and observational studies2023Acta Diabetologica
Vaccines for preventing herpes zoster in older adults2023The Cochrane Database Of Systematic Reviews
Efficacy, effectiveness, and safety of herpes zoster vaccine in the immunocompetent and immunocompromised subjects: A systematic review and network meta-analysis2022Frontiers In Immunology
Post-licensure zoster vaccine effectiveness against herpes zoster and postherpetic neuralgia in older adults: a systematic review and meta-analysis2022The Lancet. Healthy Longevity
Systematic Review and Meta-analysis of Herpes Zoster Vaccine in Patients With CKD2021Kidney International Reports
Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials2021Rheumatology (Oxford, England)
A systematic literature review of the recombinant subunit herpes zoster vaccine use in immunocompromised 18-49 year old patients2020Vaccine

Clinical Practice Guidelines