Varicella Zoster Vaccine (Recombinant)

Identification

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Name
Varicella Zoster Vaccine (Recombinant)
Accession Number
DB13924
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Inactivated / Recombinant
Description

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.

Synonyms
  • gE recombinant Varicella zoster virus (VZV) glycoprotein E
  • gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E
  • Recombinant Varicella zoster virus (VZV) glycoprotein E
External IDs
GSK-1437173A / GSK1437173A
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ShingrixSuspension50 mcgIntramuscularGlaxosmithkline Inc2018-01-02Not applicableCanada
Shingrix50 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2017-10-20Not applicableUs
Shingrix50 ug/0.5mLIntramuscularGlaxoSmithKline Biologicals SA2017-10-20Not applicableUs
Additional Data Available
  • Application Number
    Application Number

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  • Product Code
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Categories
UNII
COB9FF6I46
CAS number
Not Available

Pharmacology

Indication

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

Associated Conditions
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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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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
Toxicity
Not Available
Affected organisms
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
2-MethoxyethanolThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with 2-Methoxyethanol.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Abetimus.
ActeosideThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Adalimumab.
AfelimomabThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Afelimomab.
AldesleukinThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Aldesleukin.
AldosteroneThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Aldosterone.
AlefaceptThe therapeutic efficacy of Varicella Zoster Vaccine (Recombinant) can be decreased when used in combination with Alefacept.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Action

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Food Interactions
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. [PubMed:28426274]
  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]
External Links
RxList
RxList Drug Page
Wikipedia
Zoster_vaccine
AHFS Codes
  • 80:12.00 — Vaccines
FDA label
Download (557 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0RecruitingBasic ScienceHealthy Volunteers1
0RecruitingTreatmentChronic Lymphocytic Leukaemia (CLL) / Waldenstrom Macroglobulinemia (WM)1
1CompletedPreventionHerpes Zoster1
2Active Not RecruitingPreventionRespiratory Disorders1
2CompletedPreventionHerpes Zoster1
2CompletedPreventionHerpes Zoster / Herpes Zoster (Shingles) / Shingles1
2CompletedPreventionHerpes Zoster / Herpes Zoster Vaccine1
2Not Yet RecruitingPreventionChicken pox / Shingles / Zoster / Zoster Varicella1
3Active Not RecruitingPreventionHerpes Zoster3
3CompletedPreventionHerpes Zoster16
3RecruitingPreventionHerpes Zoster1
4Not Yet RecruitingPreventionHealthy Controls / Rheumatoid Arthritis1
4RecruitingBasic ScienceCrohn's Disease (CD) / Herpes Zoster / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis (UC)1
4RecruitingBasic ScienceInflammatory Bowel Diseases (IBD)1
4RecruitingPreventionKidney Transplant; Complications1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
SuspensionIntramuscular50 mcg
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on November 27, 2017 10:31 / Updated on October 16, 2019 13:15