MedPath

Varicella zoster vaccine (recombinant)

Generic Name
Varicella zoster vaccine (recombinant)
Brand Names
Shingrix
Drug Type
Biotech
Unique Ingredient Identifier
COB9FF6I46
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 therapy.

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 .

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. 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 .

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.

Associated Conditions
Herpes Zoster

Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

Phase 4
Conditions
Systemic Vasculitis
Spondylarthropathies
Psoriatic Arthritis
Scleroderma
Polymyalgia Rheumatica (PMR)
Juvenile Chronic Arthritis
Polyarthritis
SLE
Giant Cell Arteritis (GCA)
Interventions
Drug: vaccination with 2 doses of Shingrix vaccine
First Posted Date
2025-01-08
Last Posted Date
2025-01-10
Lead Sponsor
Region Skane
Target Recruit Count
240
Registration Number
NCT06763783
Locations
🇸🇪

Skåne University Hospital, section for rheumatology, Lund, Sweden

A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

Phase 2
Active, not recruiting
Conditions
Herpes Zoster (HZ)
Infectious Diseases
Shingles
Interventions
First Posted Date
2024-09-03
Last Posted Date
2025-03-19
Lead Sponsor
Immorna Biotherapeutics, Inc.
Target Recruit Count
467
Registration Number
NCT06581575
Locations
🇺🇸

Noble Clinical Research, Tucson, Arizona, United States

🇺🇸

Long Beach Research Institute, Long Beach, California, United States

🇺🇸

DM Clinical Research - Chicago, Chicago, Illinois, United States

and more 4 locations

Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years

Phase 1
Active, not recruiting
Conditions
Varicella Zoster Virus Infection
Herpes Zoster
Interventions
First Posted Date
2024-05-10
Last Posted Date
2025-04-24
Lead Sponsor
EuBiologics Co.,Ltd
Target Recruit Count
72
Registration Number
NCT06409494
Locations
🇰🇷

The Catholic University of Eunpyeong St.Mary's Hospital, Seoul, Korea, Republic of

A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants

Phase 1
Active, not recruiting
Conditions
Herpes Zoster
Interventions
Biological: HZ Vaccine (IN001)
Biological: Placebo
First Posted Date
2024-04-19
Last Posted Date
2024-12-27
Lead Sponsor
Shenzhen Shenxin Biotechnology Co., Ltd
Target Recruit Count
150
Registration Number
NCT06375512
Locations
🇺🇸

CenExel, Hollywood, Florida, United States

🇦🇺

Emeritus Research Pty Ltd, Melbourne, Victoria, Australia

A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years

Phase 1
Active, not recruiting
Conditions
Herpes Zoster
Interventions
Biological: LYB004 25µg
Biological: LYB004 50µg
First Posted Date
2024-03-28
Last Posted Date
2025-03-13
Lead Sponsor
Guangzhou Patronus Biotech Co., Ltd.
Target Recruit Count
48
Registration Number
NCT06335849
Locations
🇦🇺

Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above

Phase 1
Recruiting
Conditions
Vaccine-Preventable Diseases
Herpes Zoster
Interventions
First Posted Date
2023-11-18
Last Posted Date
2024-11-19
Lead Sponsor
CHA Vaccine Institute Co., Ltd.
Target Recruit Count
32
Registration Number
NCT06137755
Locations
🇰🇷

The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Eunpyeong-gu, Korea, Republic of

🇰🇷

Bundang CHA General Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of

Immunogenicity, Reactogenicity of Shingrix in SLE

Phase 3
Recruiting
Conditions
Zoster
Systemic Lupus Erythematosus
Vaccine Reaction
Interventions
Drug: Placebo
First Posted Date
2023-08-21
Last Posted Date
2023-08-21
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
63
Registration Number
NCT06001606
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years

Phase 1
Completed
Conditions
Herpes Zoster
Interventions
Biological: Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)
Biological: Zoster Vaccine Recombinant, Adjuvanted (Shingrix)
Biological: IH saline
Biological: IH ChAdOx1-VZV
First Posted Date
2023-08-14
Last Posted Date
2024-12-04
Lead Sponsor
CanSino Biologics Inc.
Target Recruit Count
65
Registration Number
NCT05991427
Locations
🇨🇦

Canadian Center for Vaccinology, Halifax, Canada

A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults

Phase 2
Active, not recruiting
Conditions
Human
Herpes Zoster Infection
Shingles
Interventions
First Posted Date
2023-01-30
Last Posted Date
2025-05-13
Lead Sponsor
Pfizer
Target Recruit Count
900
Registration Number
NCT05703607
Locations
🇺🇸

CTI Clinical Research Center, Cincinnati, Ohio, United States

🇺🇸

DM Clinical Research, Martin Diagnostic Clinic, Tomball, Texas, United States

🇺🇸

Tri-City Cardiology, Gilbert, Arizona, United States

and more 32 locations

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age

Phase 1
Active, not recruiting
Conditions
Herpes Zoster
Interventions
First Posted Date
2023-01-27
Last Posted Date
2024-12-17
Lead Sponsor
ModernaTX, Inc.
Target Recruit Count
659
Registration Number
NCT05701800
Locations
🇺🇸

Velocity Clinical Research - Westlake, Los Angeles, California, United States

🇺🇸

Tekton Research, Inc - Longmont Center, Longmont, Colorado, United States

🇺🇸

Meridien Research, Lakeland, Florida, United States

and more 17 locations
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