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Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers

NCT05718037•Wuhan BravoVax Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy resident aged 30-70 years with body weight ≥ 50 kg for males and ≥ 45 kg for females, BMI within the range of 19.0-32.0 (including the boundary value), who can provide legal identification.
•Willing to participate in the study and sign ICF.
•Women of childbearing age shall take effective contraception measures 30 days before vaccination up to 6 months post full vaccination and not in lactation period. The pregnancy test on the day of vaccination shall be negative.
•Will attend all scheduled follow-up visits and follow the requirements of the clinical study.

Exclusion Criteria

•Smoking, and/or excessive alcohol use.
•Failed the screening test of illicit drugs, including THC.
•Axillary temperature above 37.3℃.
•History of herpes zoster.
•Received any herpes zoster vaccine.
•Received any vaccine within 14 days or live vaccine within 28 days before vaccination.
•Received gamma immunoglobulin or intravenous immunoglobulin within 3 months before vaccination.
•Have acute illness or are in the acute exacerbation phase of a chronic disease within 3 days before vaccination.
•Allergic history to any vaccine-related component; history of severe allergies to any vaccine.
•History of convulsions, epilepsy or encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, damage to nerve tissue in brain caused by chemical drug poisoning, etc.) and psychiatric history or family history of mental illness.
+9 more criteria

Key Dates

Start Date

August 1, 2023

Primary Completion Date

January 31, 2024

Completion Date

July 31, 2024

Last Updated

February 8, 2023

Enrollment

ESTIMATED participants

Conditions

Herpes Zoster

Interventions

Recombinant Zoster Vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

Zoster Vaccine Recombinant, Adjuvanted

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)

View study

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: February 8, 2023Data 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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Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

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