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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

Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

Phase 4
Not yet recruiting
Conditions
Varicella (chickenpox)
MMR Vaccine
DTaP Vaccine
Interventions
Biological: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Biological: Varicella vaccine+MMR on Day 0,DTaP on Day 30
First Posted Date
2025-03-24
Last Posted Date
2025-03-24
Lead Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Target Recruit Count
720
Registration Number
NCT06891872
Locations
🇨🇳

Chongqing Center for Disease Control and Prevention, Chongqing, China

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
First Posted Date
2025-02-13
Last Posted Date
2025-04-17
Lead Sponsor
Sanofi
Target Recruit Count
2320
Registration Number
NCT06824194
Locations
🇭🇳

Investigational Site Number : 3400003, Tegucigalpa, Honduras

🇵🇷

Investigational Site Number : 6300002, Bayamon, Puerto Rico

🇭🇳

Investigational Site Number : 3400001, San Pedro Sula, Honduras

and more 38 locations

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
First Posted Date
2025-02-13
Last Posted Date
2025-05-09
Lead Sponsor
Sanofi
Target Recruit Count
580
Registration Number
NCT06824181
Locations
🇺🇸

The Medici Medical Research- Site Number : 8400008, Hollywood, Florida, United States

🇺🇸

Atlantis Clinical Research, LLC- Site Number : 8400009, Miami, Florida, United States

🇺🇸

Helios- Site Number : 8400016, Burleson, Texas, United States

and more 8 locations

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Phase 3
Recruiting
Conditions
Pneumococcal Immunization
Interventions
Biological: PCV21 vaccine
Biological: Prevnar 20 vaccine
Biological: M-M-R II vaccine
Biological: Hexaxim Vaccine
First Posted Date
2024-12-16
Last Posted Date
2025-05-20
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
1630
Registration Number
NCT06736041
Locations
🇺🇸

Eclipse Clinical Research- Site Number : 8400029, Tucson, Arizona, United States

🇺🇸

Northwest Arkansas Pediatrics- Site Number : 8400030, Fayetteville, Arkansas, United States

🇺🇸

Century Research Institute- Site Number : 8400065, Huntington Park, California, United States

and more 67 locations

An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine

Phase 4
Conditions
Varicella
Interventions
First Posted Date
2024-07-03
Last Posted Date
2025-01-27
Lead Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Target Recruit Count
414
Registration Number
NCT06484686
Locations
🇨🇳

Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China

Correlation of Protection Against Varicella in an Exploratory Study

Not yet recruiting
Conditions
Varicella
Interventions
First Posted Date
2024-07-01
Last Posted Date
2025-01-27
Lead Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Target Recruit Count
400
Registration Number
NCT06482216

Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines

Phase 3
Completed
Conditions
Varicella
Interventions
First Posted Date
2024-03-18
Last Posted Date
2025-01-27
Lead Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Target Recruit Count
642
Registration Number
NCT06314724
Locations
🇵🇭

San Juan de Dios Educational Foundation, lnc., Pasay, Philippines

🇵🇭

Cardinal Santos Medical Center, San Juan City, Philippines

Persistence of Protection by Shingrix

Phase 4
Completed
Conditions
Herpes Zoster
Interventions
First Posted Date
2019-11-19
Last Posted Date
2024-10-15
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
105
Registration Number
NCT04169009
Locations
🇺🇸

Clinical Trials Center at University of Colorado Anschutz Medical Center, Aurora, Colorado, United States

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

First Posted Date
2018-08-08
Last Posted Date
2025-01-14
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1196
Registration Number
NCT03621670
Locations
🇬🇧

GSK Investigational Site, Edinburg, United Kingdom

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Phase 3
Completed
Conditions
Healthy Volunteers (Meningococcal Infection)
Interventions
Biological: MenACYW-135 conjugate vaccine
Biological: DTaP-IPV//Hib vaccine
Biological: Pneumococcal 13-valent conjugate vaccine
Biological: Measles, mumps, rubella (MMR) vaccine
First Posted Date
2018-05-25
Last Posted Date
2024-10-14
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Target Recruit Count
2627
Registration Number
NCT03537508
Locations
🇺🇸

Helios Clinical Research Site Number : 8400109, Houston, Texas, United States

🇺🇸

Wee Care Pediatrics Syracuse Site Number : 8400024, Syracuse, Utah, United States

🇺🇸

Birmingham Pediatric Associates Site Number : 8400026, Birmingham, Alabama, United States

and more 67 locations
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