Image to be used for the 18 plus at high risk of HZ

SHINGRIX has demonstrated vaccine efficacy against Herpes Zoster in two immunocompromised (IC) patient populations ≥18 years of age (includes post-hoc analyses).1,2

SHINGRIX has been studied in a range of immunocompromised patient
populations ≥18 years of age:1-5

Graph to show Shingrix was investigated in 6 studies across 5 populations of immunocompromised patients

Efficacy for HM patients was determined in a post-hoc analysis.
*In the Haematological Malignancy study (Zoster-039), vaccine efficacy was evaluated in a post-hoc analysis

SHINGRIX is a non-live vaccine indicated for prevention of herpes zoster (HZ) and post herpetic neuralgia (PHN), in:

  • Adults aged 50 years and older
  • Adults 18 years of age or older at increased risk of HZ

The use of Shingrix should be in accordance with official recommendations.6,7

SHINGRIX DEMONSTRATED PROTECTION AGAINST HERPES ZOSTER IN PATIENTS ≥18 YOA POST AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT)1

Table showing efficacy data from Au-HSCT study

CI=confidence interval; HZ=herpes zoster; YOA: Years of age

*Data from the modified Total Vaccinated Cohort (mTVC). The modified Vaccinated Cohort excluded study participants who did not receive the second vaccine dose or those who developed an episode of herpes zoster within 1 month after receiving the second study dose.

IN A POST-HOC ANALYSIS SHINGRIX DEMONSTRATED PROTECTION AGAINST HERPES ZOSTER IN PATIENTS ≥18 YOA WITH HAEMATOLOGIC MALIGNANCIES(HM)2

Data is from a post-hoc efficacy assessment of a RCT designed to access the immunogenicity and safety of Shingrix vs Placebo in patients ≥18 YOA with haematological malignancies.

(Included patients with non-Hodgkin B cell lymphoma, chronic lymphocytic leukaemia, multiple myeloma, non-Hodgkin Tcell lymphoma, Hodgkin lymphoma and other haematological malignancies.)

Shingrix demonstrated significant efficacy in patient 18 YOA or older with HM

CI=confidence interval; HZ=herpes zoster; YOA: years of age

*The post hoc efficacy analysis was based on confirmed HZ cases and was calculated in all patients ≥18 years of age due to the small number of HZ cases.

The SHINGRIX Safety Profile in adults ≥18 years of age who are immunocompromised due to disease or therapy was consistent with that observed in immunocompetent adults ≥50 years of age.6,7

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AUTOLOGOUS-HAEMATOPOIETIC STEM CELL TRANSPLANTS (Au-HSCT) & HAEMATOLOGICAL MALIGNANCIES (HM): SOLICITED INJECTION SITE SYMPTOMS1,2,8

(OCCURRING WITHIN 7 DAYS OF VACCINATION)

Solicited injection site symptoms Au-HSCT and HM studies

*Grade 3 pain defined as pain that prevents normal activity;
n = number of participants recording reaction N = total number of participants
Total vaccinated cohort (TVC) within 7 days of vaccination. Data are the number of participant reporting an AE at least once out of the TVC.

Solicited Injection site symptoms summary points:

As expected, SHINGRIX was more reactogenic than placebo.
This was largely due to injection site reactions (ISRs) which occurred in:

  • 86% vaccine recipients vs 10% of placebo recipients in au-HSCT trial
  • 83.8% (n=233) vaccine recipients vs 17.5% (n=48) placebo recipients in Haematological malignancies trial

Pain was the most common ISR.
Solicited ISRs were generally transient with a median duration of up to 3 days in vaccine recipients.

AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT) & HAEMATOLOGICAL MALIGNANCIES(HM): SOLICITED GENERAL SYMPTOMS1,2,8

(OCCURRING WITHIN 7 DAYS OF VACCINATION)

n = number of participants recording reaction; N = total number of participants;
Total vaccinated cohort (TVC) within 7 days of vaccination. Data are the number of participant reporting an AE at least once out of the TVC.

Solicited general symptoms: summary points:

Solicited general symptoms were more frequently reported in vaccine recipients:

  • 75% (n=678) vaccine recipients vs 51% (n=455) placebo recipients in Au-HSCT trial
  • 74.1% (n=278) vaccine recipients vs 48.9% (n=134) placebo recipients in haematological malignancies trial

Fatigue was the most common symptom.

Symptoms were generally transient with a median duration of up to 3.5 days in vaccine recipients.

Unsolicited AEs (recorded up to 30 days after each dose) were also similar between vaccine and placebo groups.

AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT): SERIOUS ADVERSE EVENTS (SAE) & EVENTS OF INTEREST1

(OCCURRING WITHIN 365 DAYS OF LAST VACCINATION)

*considered related by investigator
SAE=Serious Adverse Events 

Au-HSCT SAE & events of interest: summary points:

  • Serious Adverse Events (SAEs), potential immune-mediated diseases (pIMD), underlying disease relapses and fatalities were similar between the SHINGRIX and Placebo groups
  • The most frequent SAEs in Au-HSCT were trial neoplasms; the most frequent fatal SAEs were recurring malignancy and non-herpes zoster infections
  • Overall adverse events reported in this study were consistent with the underlying diseases, known complications of the disease, and the concomitant therapies

HAEMATOLOGICAL MALIGNANCIES (HM): SERIOUS ADVERSE EVENTS (SAE) & OTHER EVENTS OF INTEREST2

(FROM FIRST VACCINATION UNTIL STUDY END)

*considered related by investigator
SAE=Serious ADVERSE Events

HM SAE & events of interest: summary points:

  • Serious Adverse Events (SAEs), potential immune-mediated diseases, underlying disease relapses and fatalities were similar between the SHINGRIX and Placebo groups
  • The most frequent SAEs in the Haematological Malignancies trial were febrile neutropenia and pneumonia
  • Overall adverse events reported in this study were consistent with the underlying diseases, known complications of the disease, and the concomitant therapies

Identify appropriate immunocompromised patients who could benefit from SHINGRIX

Learn more about SHINGRIX

References

  1. Bastidas A, de la Serna J, El Idrissi M, et al.; for the ZOE-HSCT Study Group Collaborators. Effect of recombinant zoster vaccine on incidence of herpes zoster after autologous stem cell transplantation: a randomized clinical trial [suppl]. JAMA. 2019 July;322(2):123-133.
  2. Dagnew AF, Ilhan O, Lee WS, et al.; on behalf of the Zoster-039 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 September;19(9):988-1000.
  3. Vink P, Torelle JMR, Sanchez Fructuoso A, et al.; for the Z-041 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant: a phase 3, randomized clinical trial. Clin Infect Dis. 2020 January;70(2):181-190.
  4. Vink P, Mignorance ID, Alonso CM, et al.; on behalf of the Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: a randomized trial. Cancer. 2019 April;125(8):1301-1312.
  5. Berkowitz EM, Moyle G, Stellbrink HJ, et al for the Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 April;211:1279-1287.
  6. Shingrix. Summary of Product Characteristics (GB)
  7. Shingrix. Summary of Product Characteristics (NI)
  8. Zoster-039 Clinical study report. 116428, GSK [2013]
  9. 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.
  10. 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.
  11. DH Green Book ch 28a - Shingles. February 2016. Accessed July 2021.
  12. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom . Epidemiol infecti. 2009 137 38-472.
  13. Kimberlin DW, Whitley RJ. Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med. 2007 Mar;356 (13):1338-43.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

SHINGRIX is owned by or licensed to the GSK group of companies.
© 2022 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

December 2022 | PM-GB-SGX-WCNT-220008 (V1.0)