About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Low dose antigen and low dose adjuvant of LYB004
- Low dose antigen and high dose adjuvant of LYB004
- High dose antigen and low dose adjuvant of LYB004
- High dose antigen and high dose adjuvant of LYB004
- Placebo
- Positive control
Treatment groups
6
Treatment groupsSee each treatment group below.