NCT07400003

Brief Summary

This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. The goal of Part B is to select the optimal dosage and schedule in healthy populations aged 50 years and older to support next further study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for phase_1

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2026Apr 2027

Study Start

First participant enrolled

January 6, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 26, 2026

Last Update Submit

February 2, 2026

Conditions

Herpes ZostermRNA Vaccine

Outcome Measures

Primary Outcomes (3)

  • The incidence of adverse reactions within 30 days

    The incidence of adverse reactions within 0\~30 days after each dose vaccination.

    0~30 days after each dose vaccination

  • Seroconversion rate of gE antibody

    The seroconversion rate of gE antibody on Day 30 after two doses vaccination.

    Day 30 after two doses

  • Geometric mean concentration (GMC) of gE antibody

    The GMC of gE antibody on Day 30 after two doses vaccination.

    Day 30 after two doses

Secondary Outcomes (10)

  • Adverse reactions within 0~14 days

    0~14 days after each dose vaccination

  • Incidence of serious adverse events (SAEs)

    From the first dose to 12 months after the second dose

  • Incidence of adverse events of special interest（AESI)

    From the first dose to 12 months after the second dose

  • GMC of gE antibody

    On Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second dose

  • Geometric mean fold rise (GMFR) of gE antibody

    On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose

  • +5 more secondary outcomes

Study Arms (5)

Low-dose group

EXPERIMENTAL

Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (low dosage), with 30 days or 60 days apart

Biological: Low-dose experimental vaccine

High-dose group

EXPERIMENTAL

Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (high dosage), with 30 days or 60 days apart

Biological: High-dose experimental vaccine

Comparator A

ACTIVE COMPARATOR

Participants will receive a single dose of saline on day 0 and a single dose of herpes zoster vaccine, live on day 60

Biological: Active-controlled vaccine A

Comparator B

ACTIVE COMPARATOR

Participants will receive two doses of recombinant zoster vaccine (CHO cell), with 60 days apart

Biological: Active-controlled vaccine B

Comparator C

PLACEBO COMPARATOR

Participants will receive two doses of saline, with 60 days apart

Other: Placebo group

Interventions

Low-dose experimental vaccineBIOLOGICAL

Lyophilized herpes zoster virus mRNA vaccine

Low-dose group
High-dose experimental vaccineBIOLOGICAL

Lyophilized herpes zoster virus mRNA vaccine

High-dose group
Active-controlled vaccine ABIOLOGICAL

herpes zoster attenuated live vaccine, lyophilized

Comparator A
Active-controlled vaccine BBIOLOGICAL

Shingrix®

Comparator B
Placebo groupOTHER

Saline

Comparator C

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase I: Age ≥ 40 years; Phase II: Age ≥ 50 years;
  • Participants are able to understand and voluntarily sign the informed consent form;
  • Able to provide legal identification;
  • Participants of childbearing potential and their sexual partners agree to voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of the investigational vaccine, with no plans for sperm or egg donation;
  • Agree to comply with the visit schedule, sample collection, vaccination, and other trial procedures throughout the study period, and remain accessible at all times during the trial.

You may not qualify if:

  • History of chickenpox or herpes zoster in adulthood;
  • History of chickenpox or herpes zoster vaccination (including administration of registered products or participation in clinical trials of chickenpox or herpes zoster vaccines);
  • Close contact with patients infected with chickenpox or herpes zoster within the past 30 days;
  • Clinically significant abnormalities in protocol-specified clinical laboratory tests prior to vaccination (applicable to Phase I clinical trials only):
  • A. Hematological parameters: White blood cell count (WBC), hemoglobin (Hb), platelet count (Plt); B. Blood biochemical parameters: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), fasting blood glucose (Glu), creatinine (CR); C. Urinalysis parameter: Urine protein (PRO); D. Coagulation parameters: Prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fib), international normalized ratio (INR); E. 12-lead electrocardiogram (ECG).
  • Poorly controlled chronic diseases or significant medical history, including but not limited to cardiovascular diseases (e.g., poorly controlled hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for participants aged 40-59 years prior to enrollment, or systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg for participants aged ≥60 years), metabolic disorders (e.g., poorly controlled diabetes), hematological diseases, hepatic or renal diseases, digestive system diseases, respiratory system diseases, history of major organ transplantation, or malignancy within the past five years;
  • History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
  • Autoimmune diseases, immunodeficiency diseases, or family history thereof (including but not limited to psoriasis, systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, acute disseminated encephalomyelitis, facial paralysis, hypersensitivity reactions, polymyalgia rheumatica, rheumatoid arthritis, Guillain-Barré syndrome, asplenia, functional asplenia, HIV infection);
  • Coagulation disorders (e.g., coagulation factor deficiencies, platelet abnormalities, or other coagulopathies);
  • Current or previous severe neurological disorders (epilepsy, convulsions, or seizures) or psychiatric illnesses, or family history of psychiatric disorders;
  • Acute illnesses or acute exacerbations of chronic diseases within the past 7 days, or known or suspected active infections;
  • Immunosuppressive therapy or other immunomodulatory treatments (prednisone ≥20 mg/day or equivalent for \>14 days), cytotoxic therapy within the past 6 months, or planned use during the trial;
  • Administration of immunoglobulins or other blood products within the past 3 months (use of hepatitis B immunoglobulin within the past 1 month), or planned use during the trial;
  • Participation in other clinical studies within the past 30 days or planned participation during this trial;
  • Vaccination with live-attenuated vaccines or nucleic acid vaccines within the past 28 days, or vaccination with subunit, inactivated, or other types of vaccines within the past 14 days;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

Xinjiang, 831100, China

RECRUITING

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Na Xie

    Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Xie

CONTACT

86+1999015105xn@xjcdc.com

Jiao Xue

CONTACT

86+1389908999764282811@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 10, 2026

Study Start

January 6, 2026

Primary Completion

May 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)