Varicella Zoster Vaccine (Live/Attenuated)

Identification

Name
Varicella Zoster Vaccine (Live/Attenuated)
Accession Number
DB10318
Type
Biotech
Groups
Approved
Biologic Classification
Vaccines
Attenuated
Description

Live attenuated zoster vaccine is available as two products: Zostavax for the prevention of shingles in immunocompetent people over the age of 50, and Varivax for the prevention of chickenpox in individuals 12 months of age and older. While the two vaccines contain the same immunological components and provide protection against the same virus, Zostavax contains a higher dose and is used in older adults to prevent the development of shingles and post-herpetic neuralgia.

First approved in May 2006 by the Food and Drug Administration, Zostavax was the first vaccine available for the prevention of shingles. Since October 2017, however, it has been replaced as first line therapy by Shingrix (Varicella Zoster Vaccine (Recombinant)), a more effective and longer lasting vaccine[3]. Both Varivax and Zostavax are composed of a lyophilized preparation of live, attenuated Oka/Merck strain of varicella-zoster virus.

Varicella Zoster Virus (VZV) is the virus that commonly causes Chickenpox (also known as Varicella) in childhood [4]. 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, known as shingles (or Herpes Zoster). 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 [2].

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. 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. Efficacy for prevention of shingles is highest in patients 60-69 years old and decreases with increasing age. 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.

Synonyms
  • Chickenpox vaccine
  • Human herpesvirus 3 live (attenuated) antigen
  • Varicella vaccine
  • Varicella virus vaccine live (oka-merck) strain
  • Varicella zoster live (attenuated) antigen
  • Varicella zoster live(attenuated) antigen
  • Varicella-zoster virus (live, attenuated)
  • Varicella-zoster virus strain oka/merck live (attenuated) antigen
  • Varicella-zoster virus strain oka/merck live antigen
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
VarivaxInjection, powder, lyophilized, for suspension1350 [PFU]/0.5mLSubcutaneousMerck Sharp & Dohme Corp.1995-03-17Not applicableUs
VarivaxInjection, powder, lyophilized, for suspension1350 [PFU]/0.5mLSubcutaneousMerck Sharp & Dohme Corp.1995-03-17Not applicableUs
Varivax IIIPowder, for solution1350 unitSubcutaneousMerck Ltd.2002-12-02Not applicableCanada
ZostavaxInjection, powder, lyophilized, for suspension19400 [PFU]/0.65mLSubcutaneousMerck Sharp & Dohme Corp.2006-05-25Not applicableUs
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
ProQuadVaricella Zoster Vaccine (Live/Attenuated) (9772 [PFU]/0.5mL) + Measles virus strain enders' attenuated edmonston live antigen (1000 [TCID_50]/0.5mL) + Mumps virus strain b level jeryl lynn live antigen (20000 [TCID_50]/0.5mL) + Rubella virus vaccine (1000 [TCID_50]/0.5mL)Injection, powder, lyophilized, for suspensionSubcutaneousMerck Sharp & Dohme Limited2005-09-062018-08-31Us
ProQuadVaricella Zoster Vaccine (Live/Attenuated) (3.99 log10 tcid50/0.5mL) + Measles virus strain enders' attenuated edmonston live antigen (3 log10 tcid50/0.5mL) + Mumps virus strain b level jeryl lynn live antigen (4.3 log10 tcid50/0.5mL) + Rubella virus vaccine (3 log10 tcid50/0.5mL)Powder, for solutionSubcutaneousMerck Ltd.2014-05-09Not applicableCanada
ProQuadVaricella Zoster Vaccine (Live/Attenuated) (9772 [PFU]/0.5mL) + Measles virus strain enders' attenuated edmonston live antigen (1000 [TCID_50]/0.5mL) + Mumps virus strain b level jeryl lynn live antigen (20000 [TCID_50]/0.5mL) + Rubella virus vaccine (1000 [TCID_50]/0.5mL)Injection, powder, lyophilized, for suspensionSubcutaneousMerck Sharp & Dohme Corp.2015-07-01Not applicableUs
VarilrixVaricella Zoster Vaccine (Live/Attenuated) (2000 unit) + Water (0.5 ml)Powder, for solutionSubcutaneousGlaxosmithkline Inc2003-04-09Not applicableCanada
Categories
UNII
GPV39ZGD8C
CAS number
Not Available

Pharmacology

Indication

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

Varivax vaccine is indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

Associated Conditions
Pharmacodynamics
Not Available
Mechanism of action

Zostavax provides protection against Herpes Zoster reactivation by eliciting an immune response to Varicella Zoster Virus (VZV).

Varivax provides protection against chickenpox by eliciting both cell-mediated and humoral immune responses to varicella-zoster virus.

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
DrugInteraction
2-MethoxyethanolThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/Attenuated) is combined with 2-Methoxyethanol.
2-MethoxyethanolThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with 2-Methoxyethanol.
6-Deoxyerythronolide BThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with 6-Deoxyerythronolide B.
9-(N-methyl-L-isoleucine)-cyclosporin AThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/Attenuated) is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbacavirThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with Abacavir.
AbataceptThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/Attenuated) is combined with Abatacept.
AbataceptThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with Abatacept.
AbetimusThe risk or severity of infection can be increased when Varicella Zoster Vaccine (Live/Attenuated) is combined with Abetimus.
AbetimusThe therapeutic efficacy of Varicella Zoster Vaccine (Live/Attenuated) can be decreased when used in combination with Abetimus.
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. CDC - Clinical Overview of Shingles (Herpes Zoster) [Link]
  3. CDC - What Everyone Should Know about Shingles Vaccine [Link]
  4. CDC - About Chickenpox [Link]
External Links
PubChem Substance
347910497
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Zoster_vaccine
AHFS Codes
  • 80:12.00 — Vaccines
FDA label
Download (408 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingBasic ScienceHerpes Zoster / Shingles1
1Active Not RecruitingPreventionImmunosenescence / Shingles1
1CompletedPreventionHerpes Zoster3
1CompletedPreventionImmunization; Infection / Varicella Zoster1
1CompletedPreventionVaricella (Chicken Pox)1
1RecruitingTreatmentNeuroblastomas / Sarcoma, Osteogenic / Sarcomas1
1TerminatedPreventionChickenpox / Renal Transplant Recipient Patients / Transplantation, Kidney / Varicella Zoster1
1, 2CompletedPreventionDengue Fever1
1, 2TerminatedPreventionMumps / Rubella / Rubeola / Varicella1
1, 2WithdrawnPreventionHerpes Zoster1
2Active Not RecruitingPreventionAnkylosing Spondylitis (AS) / Arthritis / Crohn's Disease (CD) / Enteropathic Arthritis / Inflammatory Arthritis / Psoriasis / Psoriatic Arthritis / Rheumatoid Arthritis1
2CompletedPreventionHaemophilus Influenzae Type B / Neisseria Meningitidis1
2CompletedPreventionHerpes Zoster2
2CompletedPreventionHerpes Zoster / Human Immunodeficiency Virus (HIV) Infections1
2CompletedPreventionMeningitis / Meningococcal Infections1
2CompletedPreventionMumps / Rubella / Rubeola1
2CompletedPreventionVaricella1
2CompletedPreventionVaricella / Varicella (Chickenpox)1
2RecruitingPreventionAnkylosing Spondylitis (AS) / Arthritis / Crohn's Disease (CD) / Enteropathic Arthritis / Inflammatory Arthritis / Psoriasis / Psoriatic Arthritis / Rheumatoid Arthritis1
2RecruitingPreventionHerpes Zoster / Inflammatory Diseases / Rheumatoid Arthritis1
2, 3RecruitingPreventionHealthy Children1
2, 3RecruitingTreatmentImmunosuppression / Liver Diseases / Varicella1
2, 3Unknown StatusPreventionHepatitis A / Varicella1
3Active Not RecruitingPreventionVaricella1
3CompletedNot AvailableMumps / Rubeola / Varicella1
3CompletedPreventionChicken-pox Illness (Varicella Virus Disease)1
3CompletedPreventionDiphtheria / Pertussis / Poliomyelitis / Rubeola / Tetanus1
3CompletedPreventionEncephalitis, Japanese B / Varicella1
3CompletedPreventionFlu caused by Influenza1
3CompletedPreventionHaemophilus Influenza b Infections / Haemophilus Influenzae Type B / Meningococcal Infections / Neisseria Meningitidis / Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine1
3CompletedPreventionHaemophilus Influenzae Type B / Haemophilus Influenzae Type B Infection / Meningococcal Infections / Neisseria Meningitidis1
3CompletedPreventionHepatitis A1
3CompletedPreventionHerpes Zoster5
3CompletedPreventionHerpes Zoster / Infections, Pneumococcal1
3CompletedPreventionHerpes Zoster / Shingles2
3CompletedPreventionHerpes Zoster / Varicella-zoster Vaccine1
3CompletedPreventionMeasles; Mumps; Rubella1
3CompletedPreventionMeningitis / Meningococcal Infections1
3CompletedPreventionMumps / Rubella / Rubeola2
3CompletedPreventionMumps / Rubella / Rubeola / Varicella6
3CompletedPreventionPrevention of : Herpes-Zoster1
3CompletedPreventionShingles1
3CompletedPreventionVaricella1
3CompletedPreventionVaricella Virus Infection1
3RecruitingPreventionInfections, Pneumococcal1
3RecruitingPreventionMeningococcal Infections2
3TerminatedPreventionMumps / Rubella / Rubeola / Varicella1
3Unknown StatusTreatmentImmunosuppression / Transplantation, Organ1
4Active Not RecruitingNot AvailableHealthy Volunteers1
4Active Not RecruitingBasic ScienceShingles1
4Active Not RecruitingPreventionSystemic Lupus Erythematosus (SLE)1
4Active Not RecruitingPreventionTransplant, Kidney1
4CompletedNot AvailableMumps / Rubella / Rubeola / Varicella1
4CompletedPreventionFibrosis / Herpes Zoster1
4CompletedPreventionFlu caused by Influenza / Respiratory Infections, Acute1
4CompletedPreventionHerpes Zoster1
4CompletedPreventionHerpes Zoster / Shingles1
4CompletedTreatmentAsthma Bronchial1
4Enrolling by InvitationPreventionCartilage-hair Hypoplasia1
4Enrolling by InvitationPreventionVaricella1
4Not Yet RecruitingHealth Services ResearchPersistence of Varicella Immunity1
4RecruitingBasic ScienceShingles1
4RecruitingPreventionHepatitis A / Rubeola / Varicella1
4RecruitingPreventionHerpes Zoster1
4TerminatedPreventionPsoriasis1
4Unknown StatusPreventionImmune Response to Zoster Vaccine1
Not AvailableActive Not RecruitingNot AvailableHerpes Zoster / Shingles1
Not AvailableCompletedNot AvailableHematopoietic Stem Cell Transplant (HSCT)1
Not AvailableCompletedNot AvailableImmune System Diseases1
Not AvailableCompletedNot AvailableVaricella1
Not AvailableCompletedBasic ScienceHealthy Volunteers1
Not AvailableCompletedBasic ScienceShingles1
Not AvailableCompletedPreventionShingles1
Not AvailableRecruitingPreventionBruton's agammaglobulinemia / Common Variable Immune Deficiency (CVID) / Specific Antibody Deficiency1
Not AvailableRecruitingPreventionHerpes Zoster1
Not AvailableRecruitingPreventionVaricella Zoster Virus Infection1
Not AvailableTerminatedBasic ScienceHepatitis C Viral Infection1
Not AvailableWithdrawnNot AvailableTransplanted / Varicella1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, powder, lyophilized, for suspensionSubcutaneous
Powder, for solutionSubcutaneous
Injection, powder, lyophilized, for suspensionSubcutaneous1350 [PFU]/0.5mL
Powder, for solutionSubcutaneous1350 unit
Injection, powder, lyophilized, for suspensionSubcutaneous19400 [PFU]/0.65mL
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on December 01, 2015 13:03 / Updated on December 16, 2018 23:30