Efficacy Data

SHINGRIX demonstrated strong efficacy in immunocompromised patients ≥18 years of age.1

SHINGRIX Demonstrated 68.2% Efficacy Against Herpes Zoster in auHSCT Subjects (mTVC)1,*,†,‡,§

	SHINGRIX	PLACEBO
Age Group (years)	N/n	N/n	% Efficacy (95% CI)
Overall (≥18)1	870/49	851/135	68.2% (55.5, 77.6)
18 to 49	213/9	212/29	71.8% (38.7, 88.3)
≥50	657/40	639/106	67.3% (52.6, 77.9)

*Median duration of follow-up period was 21 months (range: 0 to 49.4 months).1

†mTVC=modified total vaccinated cohort, defined as subjects who received 2 doses (0 and 1 to 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose. Follow-up was censored at the time of treatment for relapse.1

‡Primary study endpoint was based on confirmed HZ cases in subjects aged ≥18 years.1

§NCT01610414.1

auHSCT=autologous hematopoietic stem cell transplant; Cl=confidence interval; HZ=herpes zoster; N=number of subjects in each group; n=number of subjects having at least 1 confirmed HZ episode.

SHINGRIX Also Demonstrated 89.3% Efficacy Against PHN in auHSCT Subjects (mTVC)^1,*^,†,‡

	SHINGRIX	PLACEBO
PHN1,2	N/n	N/n	% Efficacy (95% CI)
PHN1,2	870/1	851/9	89.3% (22.5, 99.8)

The benefit of SHINGRIX in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ¹

Data from a descriptive analysis.¹

*NCT01610414.¹

†Modified total vaccinated cohort, defined as subjects who received 2 doses (0 and 1 to 2 months) of either SHINGRIX or placebo and did not develop a confirmed case of HZ within 1 month after the second dose. Follow-up was censored at the time of treatment for relapse.¹

‡Postherpetic neuralgia, defined as HZ-associated pain rated as a 3 or greater (on a 0- to 10-point scale) occurring or persisting at least 90 days following the onset of rash using Zoster Brief Pain Inventory questionnaire.¹

auHSCT=autologous hematopoietic stem cell transplant; Cl=confidence interval; HZ=herpes zoster; N=number of subjects in each group; n=number of subjects having PHN; PHN=postherpetic neuralgia.

Study Details

SHINGRIX in auHSCT Subjects: Study Details (TVC)^1,*^,†

STUDY DESCRIPTION

Phase 3, randomized, observer-blind, placebo-controlled multinational study (N=1846 [TVC])1,3

PRIMARY OBJECTIVE

Vaccine efficacy in the prevention of HZ3

POPULATION

auHSCT recipients,

≥18 years of age (mean age 55 years), SHINGRIX n=922, placebo n=9243

AGE BREAKDOWN

SHINGRIX: 18 to 49 YOA n=230 (24.9%), ≥50 YOA n=692 (75.1%)

Placebo: 18 to 49 YOA n=229 (24.8%), ≥50 YOA n=695 (75.2%)3

UNDERLYING DISEASE

Multiple myeloma, SHINGRIX n=490 (53.1%), placebo n=493 (53.4%)

NHBCL, SHINGRIX n=257 (27.9%),

placebo n=273 (29.5%)

Other disease,‡ SHINGRIX n=175 (19.0%), placebo n=158 (17.1%)3

DOSING

2-dose series (0.5 mL each) administered at month 0 (50 to 70 days post-auHSCT), followed by a second dose 1 to 2 months later³

Antivirals against varicella zoster virus were permitted; however, patients were excluded if the antiviral therapy was expected to last >6 months post-transplant.3

*NCT01610414.1

†Total vaccinated cohort included all participants who recieved at least 1 dose of SHINGRIX or placebo.3

‡Additional underlying diseases for which auHSCT was performed included Hodgkin lymphoma, non-Hodgkin T-cell lymphoma, acute myeloid leukemia, and others, including solid malignancies.3

auHSCT=autologous hematopoietic stem cell transplant; HZ=herpes zoster; mL=milliliter; n=number of subjects per group (SHINGRIX or placebo) included in the TVC; NHBCL=non-Hodgkin B-cell lymphoma; TVC=total vaccinated cohort; YOA=years of age.

In Subjects With Hematologic Malignancies, SHINGRIX Demonstrated Strong Efficacy Against Shingles in a Post-Hoc Analysis (mTVC)^{1,4,*,†, ‡}

SHINGRIX

PLACEBO

Age Group

(years)

N/n

N/n

% Efficacy

(95% CI)

Overall

(≥18)

259/2

256/14

87.2%

(44.2, 98.6)

*Median duration of follow-up period was 11.1 months (range: 0-15.6 months).1

†Post-hoc efficacy analysis was based on confirmed HZ cases in subjects aged ≥18 years.5

‡mTVC=modified total vaccinated cohort, which included all participants from the total vaccinated cohort, except those who did not receive the second dose or who developed a confirmed case of HZ before 30 days after Dose 2.5

Cl=confidence interval; HZ=herpes zoster; N=number of subjects in group; n=number of subjects having at least 1 confirmed HZ episode.

Study Details

SHINGRIX in Subjects With Hematologic Malignancies: Study Details (TVC)^*

STUDY DESCRIPTION

The efficacy of SHINGRIX was calculated post-hoc in a phase 3, randomized, observer-blind placebo-controlled, multicenter study (N=562 [TVC])5

PRIMARY OBJECTIVE

Humoral immunogenicity, safety, and reactogenicity5,†

POPULATION

Adults

≥18 YOA (mean age 57.3 years) with hematologic malignancies (SHINGRIX n=283, placebo n=279)4,5

AGE BREAKDOWN

SHINGRIX: 18 to 49 YOA n=74 (26.1%), ≥50 YOA n=209 (73.9%)

Placebo: 18 to 49 YOA n=73 (26.2%), ≥50 YOA n=206 (73.8%)5

UNDERLYING DISEASE

The most common underlying malignancies were: Multiple myeloma, SHINGRIX n=67 (23.7%), placebo n=65 (23.3%)

Hodgkin lymphoma, SHINGRIX n=49 (17.3%),

placebo n=47 (16.8%)

Other disease,‡ SHINGRIX n=167 (59%), placebo n=167 (59.9%)5

DOSING

2-dose series (0.5 mL each) administered 1 to 2 months apart, with the first dose given during or within 6 months of completing immunosuppressive therapy^5,§

*Total vaccinated cohort included all participants who received at least 1 dose of SHINGRIX or placebo.5

†Primary immunogenicity analysis excluded patients with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukemia.5

‡Additional underlying diseases included chronic lymphocytic leukemia, non-Hodgkin B-cell lymphoma, non-Hodgkin T-cell lymphoma, and other hematologic malignancies including acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, and others.5

§Participants were vaccinated during a cancer therapy course (each dose was administered with at least 10 days between vaccination and cancer therapy cycles) or after the full cancer therapy course (first dose of the study vaccine between 10 days and 6 months after cancer therapy has ended).5

TVC=total vaccinated cohort; YOA=years of age.

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Safety Profile

Learn about the safety profile of SHINGRIX in immunocompromised patients aged 18 years and older.

Incidence of Shingles

Learn about the incidence of shingles in immunocompromised patients aged 18 years and older.

CDC Recommendations

See what CDC says about SHINGRIX.

Indication & Important Safety Info

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
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.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
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.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
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.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)
Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)
Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
Vaccination with SHINGRIX may not result in protection of all vaccine recipients

References: 1. Prescribing Information for SHINGRIX. 2. Data on file. Study 115523 (NCT01610414). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=115523 3. Bastidas A, de la Serna J, El ldrissi M, et al. JAMA. 2019;322(2):123-133. 4. Data on file. Study 116428 (NCT01767467). GSK Study Register. Study entry at: https://www.gsk-studyregister.com/en/trial-details/?id=116428 5. Dagnew AF, llhan O, Lee WS, et al. Lancet Infect Dis. 2019:19(9):988-1000.

You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.

Trademarks are owned by or licensed to the GSK group of companies.

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Efficacy Data

SHINGRIX demonstrated strong efficacy in immunocompromised patients ≥18 years of age.1

SHINGRIX Demonstrated 68.2% Efficacy Against Herpes Zoster in auHSCT Subjects (mTVC)1,*,†,‡,§

SHINGRIX Also Demonstrated 89.3% Efficacy Against PHN in auHSCT Subjects (mTVC)1,*,†,‡

SHINGRIX in auHSCT Subjects: Study Details (TVC)1,*,†

In Subjects With Hematologic Malignancies, SHINGRIX Demonstrated Strong Efficacy Against Shingles in a Post-Hoc Analysis (mTVC)1,4,*,†, ‡

SHINGRIX in Subjects With Hematologic Malignancies: Study Details (TVC)*

You may also be interested in:

SHINGRIX Also Demonstrated 89.3% Efficacy Against PHN in auHSCT Subjects (mTVC)^1,*^,†,‡

SHINGRIX in auHSCT Subjects: Study Details (TVC)^1,*^,†

In Subjects With Hematologic Malignancies, SHINGRIX Demonstrated Strong Efficacy Against Shingles in a Post-Hoc Analysis (mTVC)^{1,4,*,†, ‡}

SHINGRIX in Subjects With Hematologic Malignancies: Study Details (TVC)^*