NAV

Varicella zoster vaccine (recombinant)

Identification

Brand Names
Shingrix
Generic Name
Varicella zoster vaccine (recombinant)
DrugBank Accession Number
DB13924
Background

Recombinant zoster vaccine, manufactured as the product Shingrix by GlaxoSmithKline, is an adjuvanted non-live recombinant vaccine indicated for prevention of shingles. First approved in October 2017 by the Food and Drug Administration, Shingrix is the preferred vaccine for preventing varicella zoster infection in people aged 50 years and older, replacing Zostavax as first line therapy4.

Herpes zoster, also known as shingles, is caused by a reactivation of Varicella Zoster Virus (VZV), the virus that commonly causes Chickenpox in childhood. Following initial infection of VZV and resolution of Chickenpox as a child, VZV then lies dormant within the dorsal root ganglion of the central nervous sytem. Decades later, when the body's immune system weakens with age, VZV is able to reactivate and descend through the nerve cells to the surface of the skin where it causes a painful blistering rash. Risk factors for developing shingles include old age, with rates increasing substantially in person's over the age of 50, low immune function or immunosuppression, psychological stress, and diabetes. Person's living with HIV or cancer, those taking immunosuppressants, and transplant recipients are particularly at risk 3.

One of the most common complications associated with shingles is the development of Post-Herpetic Neuralgia (PHN), a persistant severe nerve pain that develops as a result of chronic pain from shingles lesions. PHN can last for days, months, or even years following resolution of shingles. Other complications also include bacterial infection, spread of the shingles rash to the eye (herpes zoster ophthalmicus) or ear, nerve palsies, or spread of VZV to non-immune persons via contact with varicella lesions.

There are numerous advantages to using Shingrix over Zostavax. Clinical trials for Shingrix have shown greater than 90% efficacy in adults aged 50 and older, with 89% efficacy in preventing postherpetic neuralgia in patients 70 years and older and 91% efficacy in patients 50-70 years of age Label. This is a significant improvement over its predecessor, Zostavax, which reduces the risk of shingles by only 51% and the risk of post-herpetic neuralgia by 67% 1. Efficacy of Zostavax also wanes over time, with protection against shingles and PHN lasting only around 5 years. Furthermore, because Shingrix is an inactivated vaccine it can also be used to prevent shingles and PHN in individuals with suppressed immune systems, who are already at increased risk of developing shingles, while Zostavax, a live attenuated vaccine, is contraindicated.

The main immunological component of Shingrix vaccine is glycoprotein E (gE), a protein found on the surface of varicella zoster virus (VZV). Immune exposure to gE protein stimulates the development of anti-gE antibodies, and therefore adaptive immunity to VZV. Shingrix also contains an adjuvant system, AS01B, which is intended to enhance the immunological response to the vaccine leading to longer lasting and greater immunogenicity to the herpes zoster virus 2.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Recombinant
Synonyms
  • gE recombinant Varicella zoster virus (VZV) glycoprotein E
  • gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E
  • Recombinant Varicella zoster virus (VZV) glycoprotein E
  • Recombinant varicella zoster virus glycoprotein E antigen
External IDs
  • GSK-1437173A
  • GSK1437173A

Pharmacology

Indication

Varicella zoster vaccine is indicated for the prevention of herpes zoster (HZ) (shingles) in adults aged 50 years and older and 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.5

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Not Available

Mechanism of action

Shingrix provides protection against Herpes Zoster reactivation by eliciting an immune response to Varicella Zoster Virus (VZV). The main immunological component of Shingrix vaccine is glycoprotein E (gE), a protein found on the surface of varicella zoster virus (VZV). Immune exposure to gE protein stimulates the development of anti-gE antibodies, and therefore adaptive immunity to VZV 1. The adjuvant system, AS01B, is also included in Shingrix to enhance the immunological response to the vaccine leading to longer lasting and greater immunogenicity to the herpes zoster virus 2.

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
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interactions in your software
AbataceptThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
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Food Interactions
Not Available

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ShingrixInjection, powder, lyophilized, for suspension; Kit50 ug/0.5mLIntramuscularA-S Medication Solutions2017-10-20Not applicableUS flag
Shingrix50 µg/0.5mlIntramuscularGlaxo Smithkline Biologicals Sa2021-02-12Not applicableEU flag
ShingrixInjection, powder, lyophilized, for suspension; Kit50 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2017-10-20Not applicableUS flag
ShingrixSuspension50 mcgIntramuscularGlaxosmithkline Inc2018-01-02Not applicableCanada flag
ShingrixInjection, powder, lyophilized, for suspension; Kit50 ug/0.5mLIntramuscularA-S Medication Solutions2017-10-20Not applicableUS flag
Shingrix50 µg/0.5mlIntramuscularGlaxo Smithkline Biologicals Sa2021-02-12Not applicableEU flag
ShingrixInjection, powder, lyophilized, for suspension; Kit50 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2017-10-20Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
COB9FF6I46
CAS number
Not Available

References

General References
  1. Bharucha T, Ming D, Breuer J: A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Hum Vaccin Immunother. 2017 Aug 3;13(8):1789-1797. doi: 10.1080/21645515.2017.1317410. Epub 2017 Apr 20. [Article]
  2. New phase 3 data on shingles vaccine Shingrix presented at CDC Advisory Meeting. [Link]
  3. CDC - Clinical Overview of Shingles (Herpes Zoster) [Link]
  4. CDC - What Everyone Should Know about Shingles Vaccine [Link]
  5. FDA Approved Drug Products: SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection [Link]
RxNav
1986820
RxList
RxList Drug Page
Wikipedia
Zoster_vaccine
FDA label
Download (557 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Not Yet RecruitingBasic ScienceChickenpox1
4Not Yet RecruitingBasic ScienceCoronavirus Disease 2019 (COVID‑19) / Malignant Lymphomas1
4Not Yet RecruitingPreventionHerpes Zoster1
4RecruitingBasic ScienceCrohn's Disease (CD) / Herpes Zoster / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis1
4RecruitingBasic ScienceInflammatory Bowel Diseases (IBD)1
4RecruitingPreventionHealthy Controls / Rheumatoid Arthritis1
4SuspendedPreventionAdverse Drug Events (ADEs) / Injection Site Reactions / Pain / Quality of Life (QOL)1
4SuspendedPreventionTransplanted Kidney Complication1
3Active Not RecruitingPreventionHerpes Zoster3
3CompletedPreventionHerpes Zoster14

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, for suspensionIntramuscular50 µg
Injection, powder, lyophilized, for suspension; kitIntramuscular50 ug/0.5mL
SuspensionIntramuscular50 mcg
Injection, powder, lyophilized, for liposomal suspensionIntramuscular50 mcg/0.5mL
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at November 27, 2017 17:31 / Updated at June 03, 2022 07:24