Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

NCT06874842 | Recruiting Phase 1 DMC

• 1 other identifier: LYB004/CT-CHN-101
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Conditions

Herpes Zoster (HZ)

Keywords

herpes zoster; shingles; varicella zoster virus; Virus-Like Particles; vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence of immediate adverse events

  The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination

  Within 30 minutes after each vaccination

• Incidence of solicited AE

  Occurrence and severity of solicited local injection site reactions for 14 days (Day 0-Day 14) following each vaccination. (i.e., pain, redness, swelling). Occurrence and severity of solicited systemic reactions for 14 days (Day 0-Day 14) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever).

  Within 0-14 days after each vaccination

• Incidence of unsolicited AEs

  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

• Incidence of clinically significant abnormalities in clinical laboratory tests

  The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after each vaccination

  3 days after each vaccination

Secondary Outcomes (9)

• 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 seroconversion rate of anti-Varicella Zoster Virus (VZV) antibody

  30 days and 60 days after first vaccination, 14 days, 30 days, 6 months and 12 months after second vaccination

• The seroconversion rate of anti-glycoprotein E (gE) antibody

  30 days and 60 days after first vaccination, 14 days, 30 days, 6 months and 12 months after second vaccination

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

  30 days and 60 days after first vaccination, 14 days, 30 days, 6 months and 12 months after second vaccination

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

  30 days and 60 days after first vaccination, 14 days, 30 days, 6 months and 12 months after second vaccination

Study Arms (6)

Low dose antigen and low dose adjuvant of LYB004

EXPERIMENTAL

Subjects 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

Subjects 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

Placebo

PLACEBO COMPARATOR

Subjects 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

Subjects 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

High dose antigen and low dose adjuvant of LYB004

EXPERIMENTAL

Subjects 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

Subjects 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

Interventions

Low dose antigen and low dose adjuvant of LYB004 BIOLOGICAL

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

Low dose antigen and low dose adjuvant of LYB004

Low dose antigen and high dose adjuvant of LYB004 BIOLOGICAL

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

High dose antigen and high 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.

Also known as: Shingrix®

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 ≥ 37.3°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;
• Have been injected with gamma globulin or intravenous immunoglobulin within 3 months before vaccination;
• 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);
• Abnormal laboratory test indicators specified in the protocol before vaccination and determined by the clinical investigator to be of clinical significance;
• 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)

Guangdong Provincial Center for Disease Control and Prevention

Meizhou, China

RECRUITING

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

• Renfeng Fan

  Guangdong Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renfeng Fan

CONTACT

8613560231815; gdsjkzx_sws_sps@gd.gov.cn

Study Design

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

Model Details: A total of 92 healthy subjects will be enrolled and stratified by age (40-49 years，50-59 years and ≥60 years in a 5:6:8 ratio). The younger cohort (aged 40 to 49 years) will consist of 20 subjects, and these 20 subjects will be enrolled into five subgroups, including four vaccine groups, and placebo group, with the ratio of 1:1:1:1:1. The middle age cohort (aged 50 to 59 years) will consist of 24 subjects, and these 24 subjects will be enrolled into six subgroups, including four vaccine groups, placebo group and positive control group/Shingrix® group, with the ratio of 1:1:1:1:1:1. The older cohort (aged ≥60 years) will consist of 48 subjects, and these 48 subjects will be enrolled into six subgroups, including four vaccine groups, placebo group and positive control group/Shingrix® group, with the ratio of 1:1:1:1:1:1. The investigational vaccine group and the control group (placebo and positive control) are enrolled parallelly.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: March 13, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)