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What is the impact of shingles?
There is a 1 in 4 lifetime risk of developing shingles in the general population.8 Shingles is a painful disease that can have serious and long-lasting complications.9
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
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.)
*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.
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AUTOLOGOUS-HAEMATOPOIETIC STEM CELL TRANSPLANTS (Au-HSCT) & HAEMATOLOGICAL MALIGNANCIES (HM): SOLICITED INJECTION SITE SYMPTOMS3,4
(OCCURRING WITHIN 7 DAYS OF VACCINATION)
*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.
AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT) & HAEMATOLOGICAL MALIGNANCIES (HM): SOLICITED GENERAL SYMPTOMS3,4
(OCCURRING WITHIN 7 DAYS OF VACCINATION)
*Grade 3 solicited general symptoms: myalgia, fatigue, headache, shivering and GI symptoms defined as preventing normal activity. Grade 3 fever is defined as temperature >39.0°C.
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:
- 75.2% (n=678) vaccine recipients vs 50.9% (n=455) placebo recipients in Au-HSCT trial
- 74.1% (n=206) 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 similar between vaccine and placebo groups.
AUTOLOGOUS HAEMATOPOIETIC STEM CELL TRANSPLANT (Au-HSCT): SERIOUS ADVERSE EVENTS (SAE) & EVENTS OF INTEREST3
(OCCURRING WITHIN 365 DAYS OF LAST VACCINATION)
*considered related by investigator
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 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 INTEREST4
(FROM FIRST VACCINATION UNTIL STUDY END)
*considered related by investigator
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
Learn more about SHINGRIX
References
- SHINGRIX. Summary of Product Characteristics (GB)
- SHINGRIX. Summary of Product Characteristics (NI)
- 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.
- 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.
- 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.
- 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.
- 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.
- The GreenBook chapter 28a – Shingles. July 2023
- 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)
