A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older

December 16, 2025 updated by: Guangzhou Patronus Biotech Co., Ltd.

A Phase Ⅱ, Randomized, Observer-blinded, Parallel-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A randomized, observer-blinded, parallel-controlled trial will be conducted to observe the immunogenicity and safety of LYB004 in adults aged 40 years and older. A total of 840 participants aged 40 years and older will be enrolled. Four formulations of LYB004 will be provided: two dose levels of antigen and two dose levels of adjuvant. Participants aged 40-49 years old will randomly receive four investigational vaccines and the placebo in a 2:2:2:2:1 ratio. Participants aged 50 years and older will randomly receive four investigational vaccines, positive control and the placebo in a 2:2:2:2:2:1 ratio.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
840

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Hengyang, Hunan, China
        • Hengnan County Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Residents aged 40 years and older (at the time of screening), regardless of gender;
  2. Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;
  3. Participants are able to attend all planned follow-up visits and comply with the protocol requirements;
  4. Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.

Exclusion Criteria:

  1. Axillary temperature ≥ 37.0°C;
  2. History of herpes zoster before vaccination with the investigational vaccine;
  3. Previous vaccination against HZ or varicella;
  4. Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine;
  5. Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
  6. Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;
  7. Individual with the following diseases: ① Have acute diseases or are in the acute exacerbation period of chronic diseases, or take antipyretic, analgesic, and anti-allergic drugs within 3 days before vaccination; ② Allergies to any component of the study vaccine, or have a history of severe allergic reactions to any vaccination; ③ History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc. causing brain nerve tissue damage, etc.) and mental illness, or a family history of mental illness; ④ Asplenia, or functional asplenia; ⑤Primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; ⑥ Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥ 2mg/kg/day or ≥ 20mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids; ⑦ Severe cardiovascular diseases (pulmonary heart disease, pulmonary edema, etc.), severe liver and kidney diseases, complicated diabetes; ⑧ History of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection;⑨Severe hypertension that cannot be controlled by medication (on-site measurement: systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg);
  8. Those tested positive for antibodies to the Human Immunodeficiency Virus (HIV) at screening.;
  9. History of long-term alcohol abuse and/or drug abuse;
  10. Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
  11. Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination;
  12. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dose antigen and low dose adjuvant of LYB004
Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low dose antigen and low dose adjuvant of LYB004
0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01C.
Experimental: Low dose antigen and high dose adjuvant of LYB004
Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and high dose adjuvant ) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low dose antigen and high dose adjuvant of LYB004
0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01B.
Experimental: High dose antigen and low dose adjuvant of LYB004
Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High dose antigen and low dose adjuvant of LYB004
0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01C.
Experimental: High dose antigen and high dose adjuvant of LYB004
Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and high dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High dose antigen and high dose adjuvant of LYB004
0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01B.
Placebo Comparator: Placebo
Participants aged 40 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Placebo
0.5 mL per dose, without antigen and adjuvant.
Active Comparator: Positive control
Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Positive control
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Time Frame: 30 days after second vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
30 days after second vaccination
The geometric mean titer (GMT) of anti-VZV antibody
Time Frame: 30 days after second vaccination
Measured by fluorescent antibody to the membrane antigen (FAMA).
30 days after second vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of immediate adverse events
Time Frame: Within 30 minutes after each vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Within 30 minutes after each vaccination
Incidence of unsolicited AEs
Time Frame: Within 30 days after each vaccination
The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0~30 after the study intervention. vaccination
Within 30 days after each vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Time Frame: From the first vaccination up to 12 months after the second vaccination
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination up to 12 months after the second vaccination
From the first vaccination up to 12 months after the second vaccination
Incidence of solicited AE
Time Frame: Within 0-7 days after each vaccination

Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following each vaccination. (i.e., pain, redness, swelling).

Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Within 0-7 days after each vaccination
The geometric mean titer (GMT) of anti-VZV antibody
Time Frame: 60 days after first vaccination, 6 months and 12 months after second vaccination
Measured by fluorescent antibody to the membrane antigen (FAMA).
60 days after first vaccination, 6 months and 12 months after second vaccination
The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Time Frame: 60 days after first vaccination, 6 months and 12 months after second vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
60 days after first vaccination, 6 months and 12 months after second vaccination
The seroconversion rate of anti-Varicella Zoster Virus (VZV) antibody
Time Frame: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Seroconversion refers to at least a 4-fold increase in the anti-Varicella Zoster Virus (VZV) antibody titer at the endpoint as compared to the prevaccination titer if prevaccination titer is above the lower limit of quantification (LLOQ) or a 4-fold increase at the endpoint as compared to LLOQ value if prevaccination concentration is lower than LLOQ.
60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The seroconversion rate of anti-glycoprotein E (gE) antibody
Time Frame: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Seroconversion refers to at least a 4-fold increase in the anti-glycoprotein E (gE) antibody concentration at the endpoint as compared to the prevaccination concentration if prevaccination concentration is above the lower limit of quantification (LLOQ) or a 4-fold increase at the endpoint as compared to LLOQ value if prevaccination concentration is lower than LLOQ.
60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The geometric mean fold rise (GMFR) of anti-VZV antibody
Time Frame: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Change from prevaccination in geometric mean fold rise of anti-VZV antibody titer.
60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The GMFR of anti-gE antibody
Time Frame: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Change from prevaccination in geometric mean fold rise of anti-gE antibody concentration.
60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Frequencies of CD4+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
Time Frame: 30 days, 6 months and 12 months after second vaccination
The frequencies of CD4+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD4+ T cells, and the cell mediated immunity (CMI) response rates at 30 days and 6 months after second vaccination.
30 days, 6 months and 12 months after second vaccination
Frequencies of CD8+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD8+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
Time Frame: 30 days, 6 months and 12 months after second vaccination
The frequencies of CD8+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD8+ T cells, and the cell mediated immunity (CMI) response rates at 30 days after first vaccination, 30 days and 6 months after second vaccination.
30 days, 6 months and 12 months after second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Patronus Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tao Huang, Hunan Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LYB004/CT-CHN-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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