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

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.1,2

SHINGRIX has been studied in a range of immunocompromised patient
populations ≥18 years of age:3-7

Table showing study designs in immunocompromised populations

SHINGRIX DEMONSTRATED PROTECTION AGAINST HERPES ZOSTER IN PATIENTS ≥18 YOA POST AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT)3

Tables showing autologous haematopoietic stem cell transplant study design and efficacy results

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.

AUTOLOGOUS-HAEMATOPOIETIC STEM CELL TRANSPLANTS (Au-HSCT) & HAEMATOLOGICAL MALIGNANCIES (HM): SOLICITED INJECTION SITE SYMPTOMS3,4

(OCCURRING WITHIN 7 DAYS OF VACCINATION)

Table showing solicited injection site symptoms in autologous haematopoietic stem cell transplant & haematological malignancies studies

*Grade 3 injection site reactions = Grade 3 pain defined as pain that prevents normal activity; Grade 3 redness and swelling defined as >100 mm.
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 participants 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:

  • 85.8% (n=773) vaccine recipients vs 10.4% (n=93) 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.

Learn more about SHINGRIX

References

  1. SHINGRIX. Summary of Product Characteristics (GB)
  2. SHINGRIX. Summary of Product Characteristics (NI)
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. The GreenBook chapter 28a – Shingles. July 2023
  9. UK NICE Clinical Knowledge Summaries (Shingles) August 2021

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.
© 2024 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

January 2024 | PM-GB-SGX-WCNT-230018 (V2.0)

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