Status:
RECRUITING
Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
Lead Sponsor:
Guangzhou Patronus Biotech Co., Ltd.
Conditions:
Herpes Zoster (HZ)
Eligibility:
All Genders
40+ years
Phase:
PHASE1
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.
Detailed Description
A randomized, observer-blinded, positive-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults aged 40 years and older. A total of 92 healthy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06874842
Start Date
March 13 2025
End Date
October 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
Guangdong Provincial Center for Disease Control and Prevention
Meizhou, China