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Varicella zoster vaccine (live/attenuated)

Generic Name
Varicella zoster vaccine (live/attenuated)
Brand Names
Proquad, Varivax, Zostavax
Drug Type
Biotech
Unique Ingredient Identifier
GPV39ZGD8C
Background

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. 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 . 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 .

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% . 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.

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
Herpes Zoster, Varicella Zoster Virus Infection

A Study of MG1111 in Healthy Children

Phase 2
Completed
Conditions
Healthy Children
Interventions
First Posted Date
2017-12-18
Last Posted Date
2021-05-14
Lead Sponsor
Green Cross Corporation
Target Recruit Count
814
Registration Number
NCT03375502
Locations
🇰🇷

The catholic university of Korea, Seoul st. mary's hospital, Banpo-dong, Seoul, Korea, Republic of

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

Phase 4
Conditions
Shingles
Interventions
First Posted Date
2015-05-15
Last Posted Date
2018-04-06
Lead Sponsor
Louis Stokes VA Medical Center
Target Recruit Count
22
Registration Number
NCT02444936

Varicella Zoster Vaccine in Patients With Plaque Psoriasis Treated With Biologic Therapy

Phase 4
Terminated
Conditions
Psoriasis
Interventions
First Posted Date
2015-04-03
Last Posted Date
2017-07-02
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
3
Registration Number
NCT02408159
Locations
🇨🇦

Inno-6041 study site, Markham, Ontario, Canada

🇨🇦

Innovaderm Research Inc., Montreal, Quebec, Canada

Safety of Zostavax Vaccination in Rheumatoid Arthritis

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Varicella Zoster
Interventions
First Posted Date
2012-01-10
Last Posted Date
2020-03-06
Lead Sponsor
Oklahoma Medical Research Foundation
Target Recruit Count
20
Registration Number
NCT01506661
Locations
🇺🇸

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States

Zostavax in Systemic Lupus Erythematosus

Phase 1
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2011-11-18
Last Posted Date
2013-09-17
Lead Sponsor
Oklahoma Medical Research Foundation
Target Recruit Count
20
Registration Number
NCT01474720
Locations
🇺🇸

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States

Zoster Vaccine Response in the Frail Elderly

Completed
Conditions
Immune System Diseases
Interventions
First Posted Date
2011-04-04
Last Posted Date
2018-10-29
Lead Sponsor
McMaster University
Target Recruit Count
241
Registration Number
NCT01328548
Locations
🇨🇦

Macassa Lodge, Hamilton, Ontario, Canada

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