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COMPLETEDPHASE3

Study on Efficacy of Attenuated Zoster Vaccine, Live

Evaluation of the Efficacy of Attenuated Zoster Vaccine, Live From Herpes Zoster in Adults Aged 40 Years or older---a Multicenter, Randomized, Double-blinded,Placebo-controlled Trial Phase III

NCT04334577•Changchun BCHT Biotechnology Co.

View on ClinicalTrials.gov

Summary

Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes. Primary infection is manifested as varicella (chickenpox) , whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.

Detailed Description

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•01 Healthy volunteers aged 40 years or older;
•02 Able to understand and give informed consent;.
•03 Able to comply with requirements of all clinical trial protocol for completing the study;
•04 Axillary temperature ≤37.0 at the time of enrollment;

Exclusion Criteria

•05 History of herpes zoster;
•06 History of vaccination against herpes zoster or varicella ;
•07 Allergic sensitivity to any of the components (including neomycin) in the study vaccine and a history of severe allergies to other vaccine;
•08 Premenopausal with positive pregnancy test, pregnant or lactating female, or female planning to become pregnant within 6 months;
•09 Subjects with congenital history of immunity deficiency (e.g., primary immunoglobulin deficiency, isolated IgA deficiency, etc.) or family history;
•10 Receipt of immunoglobulins and/or any blood products within the 5 months preceding of study vaccine or planning to receive these products during the study period;
•11 Immunosuppression resulting from disease,such as immunodeficiency, malignant tumor, HIV infection, organ and bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease caused by low immunity; Receipt of immunosuppressive therapy with corticosteroids (except intermittent topical or inhaled corticosteroids \[\< 800 g/ d Beclomethasone or equivalent\]); Other immunosuppressive/cytotoxic treatments (cancer chemotherapy or organ transplantation);
•12 Subjects with acute infections (such as mumps, etc.), chronic infections in the acute phase (such as active untreated tuberculosis, etc.) or any advanced immune disease;
•13 Use of any investigational or non-registered product (drug, biological product or device) other than the study vaccine within 1 month before study vaccination , or planed use during the study period;
•14 Administration or planned administration of any other immunizations within 1 month before study vaccination or scheduled within the study period after study vaccination.
+7 more criteria

Locations (2)

Jiangsu Province Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Zhejiang Provincial Center for Disease Control and Prevention

Hanzhou, Zhejiang, China

Key Dates

Start Date

April 20, 2020

Primary Completion Date

July 18, 2021

Completion Date

July 18, 2021

Last Updated

December 8, 2021

Enrollment

25,000

ACTUAL participants

Conditions

Herpes Zoster

Interventions

live attenuated zoster vaccine

BIOLOGICAL

placebo

BIOLOGICAL

The Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster

NCT07378059

Herpes ZosterPain

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RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

NCT06932523

Herpes Zoster (HZ)

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RECRUITING

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study on Efficacy of Attenuated Zoster Vaccine, Live

Inclusion Criteria

Exclusion Criteria

The Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Risk Factors of Anxiety and Depression in Patients With Herpes Zoster Neuralgia

Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above

Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above