Loading clinical trials...

A Study to Evaluate the Safety of Recombinant Herpes Zoster Vaccine for Healthy Individuals | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

Randomized, Blinded, Controlled Phase I/Ⅱ Clinical Trial Evaluating the Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) for Healthy Individuals Aged 40 Years and Above

NCT06932523•Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of receiving two doses of recombinant herpes zoster vaccine (CHO cells) (RHZV) in healthy individuals aged 40 years and above. This study will be conducted in 2 substudies: Substudy A (Phase I) and Substudy B (Phase Ⅱ).

Detailed Description

There are two parts of the study. Substudy A: This substudy is the Phase I portion of the study. In this substudy, participants will receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or adjuvant controls or normal saline intramuscularly. Participants will be divided into 2 age groups: 40-49 years old and ≥ 50 years old. Participants will receive vaccinations on days 0 and 60. Participants will complete a 12-month safety follow-up after two doses of vaccination, and they will take part in this study for about 14 months. Substudy B: This substudy is the Phase Ⅱ portion of the study. In this part of the study, participants will also receive 1 of 2 RHZV candidates (different dose levels) or the approved shingles vaccine (positive control) or normal saline intramuscularly. Participants will be divided into 3 age groups: 40-49 years old, 50-69 years old and ≥ 70 years old. Participants will receive vaccinations on days 0 and 60. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants will be involved in this study for up to 2 years.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥ 40 years old on the day of enrollment, gender not limited.
•Can provide legal proof of identity.
•Be able to understand the experimental procedure and sign a written informed consent form, expressing agreement to participate in the experiment.
•Be able to participate in all planned follow-up visits and comply with all trial procedures.
•On the day of enrollment, the body temperature was less than 37.3 ℃ (axillary temperature).
•Chronic disease patients need to be in a stable period of chronic disease.
•Female and male participants of childbearing age agreed to adopt strict and effective contraceptive measures from the start of the trial to 6 months after full exemption.

Exclusion Criteria

•Individuals with a history of herpes zoster in the past.
•Individuals with a history of vaccination against chickenpox or shingles.
•Individuals who have had close contact with patients with chickenpox or shingles in the past 2 years.
•Women of childbearing age who have a positive urine pregnancy test, are breastfeeding, pregnant, or plan to become pregnant within 6 months after the start of the test and the full exemption period.
•Individuals who are allergic to any component of the vaccine or have a history of other severe allergies.
•Use immunoglobulin and/or any blood products within 3 months prior to administering the trial vaccine, or plan to use them during the trial period.
•Have taken antipyretic, analgesic, or anti allergic drugs within 72 hours prior to receiving the experimental vaccine.
•Any experimental or unregistered product (drug, vaccine, biological product or device) other than the experimental vaccine has been used within one month prior to vaccination, or is planned to be used during the trial period.
•Administer non live vaccines within 7 days prior to administering the experimental vaccine or live vaccines within 14 days prior to administering the experimental vaccine.
•Suffering from a serious illness that prevents the completion of the entire experiment.
+12 more criteria

Locations (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Key Dates

Start Date

April 4, 2025

Primary Completion Date

June 30, 2026

Completion Date

December 31, 2027

Last Updated

January 7, 2026

Enrollment

645

ESTIMATED participants

Conditions

Herpes Zoster (HZ)

Interventions

Recombinant herpes zoster vaccine with low-dose adjuvant

BIOLOGICAL

Recombinant herpes zoster vaccine with high-dose adjuvant

BIOLOGICAL

Low-dose adjuvant

BIOLOGICAL

High-dose adjuvant

BIOLOGICAL

Shingrix (GSK)

BIOLOGICAL

Normal Saline

BIOLOGICAL

Contacts

Chaorong Xu

CONTACT

02162800991 xuchaorong@sinopharm.com

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

NCT06903078

Herpes Zoster (HZ)Vascular Dementia

View study

COMPLETEDPHASE1

A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine

NCT05871541

Herpes Zoster (HZ)Shingles+1 more

View study

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 7, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions