A Phase I, Randomized, Observer-blinded, Parallel-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Guangdong Provincial Center for Disease Control and Prevention
RECRUITING
Meizhou
Contact Information
Primary
Renfeng Fan
gdsjkzx_sws_sps@gd.gov.cn
8613560231815
Time Frame
Start Date:2025-03-13
Estimated Completion Date:2026-10
Participants
Target number of participants:92
Treatments
Experimental: Low dose antigen and low dose adjuvant of LYB004
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).
Experimental: Low dose antigen and high dose adjuvant of LYB004
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).
Placebo_comparator: Placebo
Subjects aged 40 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Active_comparator: Positive control
Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Experimental: High dose antigen and low dose adjuvant of LYB004
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).
Experimental: High dose antigen and high dose adjuvant of LYB004
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).