A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older
- 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.
- Short title
- A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-12-01
- First posted
- 2025-12-30
- Registry last updated
- 2025-12-30
- Primary completion date
- 2026-01-01
- Start date
- 2025-10-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- 2:2:2:2
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07311148
- ClinicalTrials.gov ID
- NCT07311148
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Timeframe: 30 days after second vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
The geometric mean titer (GMT) of anti-VZV antibody
Timeframe: 30 days after second vaccination
Measured by fluorescent antibody to the membrane antigen (FAMA).
Occurrence of immediate adverse events
Timeframe: Within 30 minutes after each vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Incidence of solicited AE
Timeframe: 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).
Incidence of unsolicited AEs
Timeframe: 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
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Timeframe: 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
The geometric mean titer (GMT) of anti-VZV antibody
Timeframe: 60 days after first vaccination, 6 months and 12 months after second vaccination
Measured by fluorescent antibody to the membrane antigen (FAMA).
The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Timeframe: 60 days after first vaccination, 6 months and 12 months after second vaccination
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
The seroconversion rate of anti-Varicella Zoster Virus (VZV) antibody
Timeframe: 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.
The seroconversion rate of anti-glycoprotein E (gE) antibody
Timeframe: 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.
The geometric mean fold rise (GMFR) of anti-VZV antibody
Timeframe: 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.
The GMFR of anti-gE antibody
Timeframe: 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.
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
Timeframe: 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.
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
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Healthy volunteers
- Yes
- 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.
- 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;
- 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;
- Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
- Hengnan County Center for Disease Control and PreventionHengyang, China
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Chickenpox
- Herpes zoster Primary condition