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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine

A Randomized, Double-blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults

NCT06801509•Sinocelltech Ltd.

View on ClinicalTrials.gov

Summary

The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female subjects ≥ 40 years of age;
•2. The subject can and fully understand the trial procedures and voluntarily sign the ICF;
•3. The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;
•4. The subject can comply with the requirements of the protocol;
•5. The axillary temperature of the subject is \< 37.0℃ on the day of enrollment;
•6. Fertile men and women with childbearing potential voluntarily agree to take effective contraceptive measures from the first vaccination to at least 90 days after the last dose of study vaccines.

Exclusion Criteria

•1. History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
•2. Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
•3. Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
•4. History or family history of convulsions, epilepsy, and psychiatric disorders;
•5. Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;
•6. Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.
•7. History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;
•8. Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;
•9. Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.
•10. Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);
+9 more criteria

Locations (1)

Dazhu CDC

Dazhou, Sichuan, China

Key Dates

Start Date

February 15, 2025

Primary Completion Date

November 10, 2025

Completion Date

October 10, 2027

Last Updated

January 30, 2025

Enrollment

540

ESTIMATED participants

Conditions

Herpes Zoster

Interventions

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

BIOLOGICAL

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

BIOLOGICAL

Placebo control: Saline

BIOLOGICAL

Shingrix®

BIOLOGICAL

Ganwei®

BIOLOGICAL

Contacts

Dongyang Gao, Doctor

CONTACT

+86-010-58628288-9137 dongyang_gao@sinocelltech.com

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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: January 30, 2025Data 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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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine

Inclusion Criteria

Exclusion Criteria

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