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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Herpes zoster •••••••••••• ••••• Prevention of Herpes zoster •••••••••••• ••••• •••••••••••••••••• •••• •••• Prevention of Herpes zoster •••••••••••• ••••• ••••••••••••••••••• •••• •••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Varicella zoster vaccine (recombinant) can be decreased when used in combination with Alemtuzumab. - Food Interactions
- Not Available
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Shingrix Injection, powder, lyophilized, for suspension; Kit 50 ug/0.5mL Intramuscular A-S Medication Solutions 2017-10-20 Not applicable US 
Shingrix Suspension 50 mcg Intramuscular Glaxosmithkline Inc 2018-01-02 Not applicable Canada 
Shingrix Injection, powder, lyophilized, for suspension; Kit 50 ug/0.5mL Intramuscular GlaxoSmithKline Biologicals SA 2017-10-20 Not applicable US Shingrix Injection; Kit 50 µg/0.5ml Intramuscular Glaxo Smithkline Biologicals Sa 2021-02-12 Not applicable EU 
Shingrix Injection, powder, lyophilized, for suspension; Kit 50 ug/0.5mL Intramuscular A-S Medication Solutions 2017-10-20 Not applicable US
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- COB9FF6I46
- CAS number
- Not Available
References
- General References
- 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]
- New phase 3 data on shingles vaccine Shingrix presented at CDC Advisory Meeting. [Link]
- CDC - Clinical Overview of Shingles (Herpes Zoster) [Link]
- CDC - What Everyone Should Know about Shingles Vaccine [Link]
- FDA Approved Drug Products: SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection [Link]
- External Links
- 1986820
- RxList
- RxList Drug Page
- Wikipedia
- Zoster_vaccine
- FDA label
- Download (557 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Basic Science Crohn's Disease (CD) / Herpes Zoster / Inflammatory Bowel Diseases (IBD) / Ulcerative Colitis 1 4 Completed Prevention Adverse Drug Reaction (ADR) / Injection Site Reactions / Pain / Quality of Life (QOL) 1 4 Completed Prevention Healthy (Controls) / Rheumatoid Arthritis 1 4 Not Yet Recruiting Prevention Herpes Zoster 1 4 Recruiting Basic Science Coronavirus Disease 2019 (COVID‑19) / Lymphoma 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for suspension Intramuscular 50 µg Injection, powder, lyophilized, for suspension; kit Intramuscular 50 ug/0.5mL Injection; kit Intramuscular 50 µg/0.5ml Suspension Intramuscular 50 mcg Suspension Intramuscular 50.00 mcg Injection, powder, lyophilized, for liposomal suspension Intramuscular 50 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