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Efficacy data

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In adults aged ≥50 years, SHINGRIX demonstrated >90% efficacy against shingles in all age groups studied vs. placebo1-3

Table with efficacy data from the ZOE-50 and ZOE-70 clinical trials Table with efficacy data from the ZOE-50 and ZOE-70 clinical trials

Adapted from SHINGRIX Product Monograph.

In a follow-up study, SHINGRIX vaccine efficacy remained high through 9.6 years post-vaccination in adults aged ≥50 years vs. historical control4*

An interim analysis of an open-label, ongoing, long-term, follow-up study that examined efficacy data (pooled data from ZOE-50 and ZOE-70) up to 10 years after initial vaccination in adults aged ≥50 years.

<b>Table with efficacy data from</b> an open-label, ongoing, long-term, follow-up study that examined efficacy data (pooled data from ZOE-50 and ZOE-70), up to 10 years after initial vaccination <b>in</b> <b>adults aged ≥50 years.</b> <b>Table with efficacy data from</b> an open-label, ongoing, long-term, follow-up study that examined efficacy data (pooled data from ZOE-50 and ZOE-70), up to 10 years after initial vaccination <b>in</b> <b>adults aged ≥50 years.</b>

Adapted from Strezova, et al.

The duration of this study is longer than that of data in the Product Monograph.

* Vaccine efficacy was evaluated in this ongoing, Phase 3B, open-label, long-term follow-up study in the Modified Total Vaccinated Cohort (mTVC), consisting of ~50% of subjects who received both SHINGRIX doses and did not develop a confirmed HZ case before one month post-Dose 2 in ZOE-50/70. The study started on April 16, 2016, and the data lock point for this second interim analysis was on August 19, 2021, when participants had completed at least four additional years of follow-up, and data accrual was complete through Year 9. Historical control estimates of incidence rates from the ZOE-50/70 placebo groups were used to assess vaccine efficacy. The same N and follow-up period were considered for the historical control and vaccinated groups; n for historical controls represents the projected number of included placebo group participants from ZOE-50/70 with at least one confirmed herpes zoster episode based on the estimated incidence rate.

By helping prevent shingles, SHINGRIX significantly decreased the incidence of PHN in patients aged ≥70 overall in ZOE-50 and ZOE-701*

Table with efficacy data for postherpetic neuralgia from the ZOE-50 and ZOE-70 clinical trials Table with efficacy data for postherpetic neuralgia from the ZOE-50 and ZOE-70 clinical trials

Adapted from SHINGRIX Product Monograph.

The benefit of SHINGRIX on PHN can be attributed to the effect of the vaccine on the prevention of HZ. A further reduction of PHN incidence in subjects with confirmed HZ could not be demonstrated due to the limited number of HZ cases in the vaccine group.1

SHINGRIX is not indicated for the treatment of HZ or PHN.1
* PHN was defined as shingles-associated pain rated as ≥3 on a 0–10 scale, occurring or persisting for at least 90 days following the onset of rash using the Zoster Brief Pain Inventory questionnaire.1,3

Study Design for ZOE-50 and ZOE-70

In two placebo-controlled, observer-blind, Phase III trials conducted in 18 countries, subjects ≥50 years old (ZOE-50, n=15,405) and subjects ≥70 years old (ZOE-70, n=13,900) were randomized 1:1 to receive two doses (0 and 2 months) of either SHINGRIX or placebo (N=29,305).1

ZOE-50 and ZOE-70 study design infographic ZOE-50 and ZOE-70 study design infographic

Modified Total Vaccinated Cohort (mTVC): The primary efficacy analysis included all subjects randomized in the study who received a second dose of the vaccine and did not develop a confirmed case of shingles within one month after the second dose.1

Primary endpoints:1

  • ZOE-50: to evaluate the efficacy of SHINGRIX vs. placebo in reducing the risk of shingles in subjects ≥50 years old
  • ZOE-70: to evaluate the efficacy of SHINGRIX vs. placebo in reducing the risk of shingles in subjects ≥70 years old
  • The pooled analysis of ZOE-50 and ZOE-70: to evaluate the efficacy of the vaccine vs. placebo in reducing the risk of shingles and the incidence of PHN in the overall population of subjects ≥70 years old from both studies

Secondary endpoint:3

  • To evaluate the safety and reactogenicity of the vaccine

PHN = postherpetic neuralgia.

In two separate studies, SHINGRIX demonstrated efficacy against shingles in two immunocompromised patient populations aged ≥18 years vs. placebo1

Table with efficacy data from 2 separate studies in immunocompromised patient population aged ≥18 years vs placebo Table with efficacy data from 2 separate studies in immunocompromised patient population aged ≥18 years vs placebo

Adapted from SHINGRIX Product Monograph.

auHSCT = autologous hematopoietic stem cell transplant.
* Primary study endpoint was based on confirmed HZ cases in subjects aged ≥18 years.
† Confirmed HZ cases in subjects aged ≥18 years was a secondary study endpoint.
‡ Efficacy calculation was performed post-hoc.

SHINGRIX was investigated in six studies in immunocompromised patients aged ≥18 years1

a table of 6 studies in immunocompromised patients aged ≥18 years a table of 6 studies in immunocompromised patients aged ≥18 years

* This is not the recommended dosing schedule. The need for booster doses following the primary vaccination schedule has not been established. Please see the Product Monograph for dosing recommendations.1

Adapted from SHINGRIX Product Monograph.1

Most vaccine recipients were not under immunosuppressive therapy at the time of vaccination, and not all types of immunosuppressive therapies were used in the populations studied.1

As immunocompromised populations are heterogeneous, safety and immunogenicity data on SHINGRIX may not be available for all adults at increased risk of herpes zoster. Consider patients on an individual basis.1,5

Immune response data1

The immune response to SHINGRIX was evaluated in five randomized, placebo-controlled, observer-blind clinical studies in immunocompromised subjects aged ≥18 years, including auHSCT recipients, solid tumour patients, hematologic malignancy patients, renal transplant recipients, and HIV-infected subjects. 

SHINGRIX or placebo was administered according to a 0- and 1- to 2-month schedule in all studies except for the study in HIV-infected subjects (which used a 3-dose, 0-, 2-, 6-month schedule). Note this is not the recommended dosing schedule. The need for booster doses following the primary vaccination schedule has not been established. Please see the Product Monograph for dosing recommendations.1 

The gE-specific humoral and cell-mediated immune responses at 1 month post-Dose 2 in terms of the median fold increase over baseline ranged from 14.1 to 40.9 in terms of anti-gE antibody concentration and 4.9 to 109.0 in terms of gE-specific CD4[2+] T-cell frequencies (ATP cohort for immunogenicity) in all IC populations, respectively.

In subjects who received SHINGRIX according to a 0- and 1- to 2-month schedule, the humoral and cell-mediated immune responses remained above pre-vaccination levels at 1 year (and 2 years for auHSCT recipients in the ZOSTER-002 trial) post-Dose 2.

The clinical relevance in terms of impact on efficacy, on the short and long term, is unknown.

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Start the conversation about shingles risk with your patients

Nearly everyone ≥50 years old should be protected against shingles.6

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Provide eligible patients your strong recommendation to vaccinate with SHINGRIX

Review the recommendations on the use of SHINGRIX by the National Advisory Committee on Immunization (NACI).6

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Explore SHINGRIX safety profile

The safety profile of SHINGRIX in adults aged ≥50 years was extensively studied in two large Phase III clinical trials (ZOE-50 and ZOE-70). It was also evaluated in immunocompromised patients aged ≥18 years by pooling data from six placebo-controlled clinical studies involving adults who were immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised).

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References:

  1. SHINGRIX Product Monograph. GlaxoSmithKline Inc., November 15, 2022.
  2. Lal H, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372(22):2087–2096.
  3. Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016;375(11):1019–1032.
  4. Strezova A, et al. Long-term protection against herpes zoster by the adjuvanted recombinant zoster vaccine: interim efficacy, immunogenicity, and safety results up to 10 years after initial vaccination. Open Forum Infect Dis 2022;9(10):ofac485.
  5. Government of Canada. Regulatory Decision Summary – Shingrix – Health Canada. Available at: https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00909. Accessed July 29, 2022.
  6. Public Health Agency of Canada. An Advisory Committee Statement (ACS), National Advisory Committee on Immunization (NACI) – Updated Recommendations on the Use of Herpes Zoster Vaccines. Ottawa, Ontario: Public Health Agency of Canada; June 2018. Available at: https://www.canada.ca/en/services/health/publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines.html. Accessed November 30, 2022.

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