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

NCT07311148 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: LYB004/CT-CHN-201
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Zoster (HZ); Shingles; VZV; Recombinant Zoster Vaccine

Keywords

herpes zoster; varicella-zoster virus; Virus-like particles; Recombinant protein vaccine; Glycoprotein E

Outcome Measures

Primary Outcomes (2)

• The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody

  Measured by Enzyme-Linked Immunosorbent Assay (ELISA).

  30 days after second vaccination

• The geometric mean titer (GMT) of anti-VZV antibody

  Measured by fluorescent antibody to the membrane antigen (FAMA).

  30 days after second vaccination

Secondary Outcomes (12)

• Occurrence of immediate adverse events

  Within 30 minutes after each vaccination

• Incidence of solicited AE

  Within 0-7 days after each vaccination

• Incidence of unsolicited AEs

  Within 30 days after each vaccination

• Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)

  From the first vaccination up to 12 months after the second vaccination

• The geometric mean titer (GMT) of anti-VZV antibody

  60 days after first vaccination, 6 months and 12 months after second vaccination

Study Arms (6)

Low dose antigen and low dose adjuvant of LYB004

EXPERIMENTAL

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

Low dose antigen and high dose adjuvant of LYB004

EXPERIMENTAL

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

High dose antigen and low dose adjuvant of LYB004

EXPERIMENTAL

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

High dose antigen and high dose adjuvant of LYB004

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Positive control

ACTIVE COMPARATOR

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

Interventions

Low dose antigen and high dose adjuvant of LYB004 BIOLOGICAL

0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01B.

Low dose antigen and high dose adjuvant of LYB004

High dose antigen and low dose adjuvant of LYB004 BIOLOGICAL

0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01C.

High dose antigen and low dose adjuvant of LYB004

High dose antigen and high dose adjuvant of LYB004 BIOLOGICAL

0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01B.

High dose antigen and high dose adjuvant of LYB004

Low dose antigen and low dose adjuvant of LYB004 BIOLOGICAL

0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01C.

Low dose antigen and low dose adjuvant of LYB004

Placebo BIOLOGICAL

0.5 mL per dose, without antigen and adjuvant.

Placebo

Positive control BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Positive control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents aged 40 years and older (at the time of screening), regardless of gender;
• Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;
• Participants are able to attend all planned follow-up visits and comply with the protocol requirements;
• 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.

You may not qualify if:

• Axillary temperature ≥ 37.0°C;
• History of herpes zoster before vaccination with the investigational vaccine;
• Previous vaccination against HZ or varicella;
• Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine;
• Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
• 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;
• 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);
• Those tested positive for antibodies to the Human Immunodeficiency Virus (HIV) at screening.;
• History of long-term alcohol abuse and/or drug abuse;
• 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;
• Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.

Sponsors & Collaborators

• Guangzhou Patronus Biotech Co., Ltd.: lead

Study Sites (1)

Hengnan County Center for Disease Control and Prevention

Hengyang, Hunan, China

Location

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Interventions

Antigens

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Tao Huang

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 16, 2025
• First Posted: December 30, 2025
• Study Start: October 23, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)