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.
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 ≥ 37.3°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;
Parallel
Low dose antigen and low dose adjuvant of LYB004
Biological/Vaccine0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01C.
Low dose antigen and high dose adjuvant of LYB004
Biological/Vaccine0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01B.
High dose antigen and low dose adjuvant of LYB004
Biological/Vaccine0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01C.
High dose antigen and high dose adjuvant of LYB004
Biological/Vaccine0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01B.
Placebo
Biological/Vaccine0.5 mL per dose, without antigen and adjuvant.
Positive control
Biological/Vaccine0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
6
Treatment groupsSee each treatment group below.
Occurrence of immediate adverse events
The incidence and severity of any adverse events (AEs) 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).
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
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
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
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 seroconversion rate of anti-Varicella Zoster Virus (VZV) antibody
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
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 titer (GMT) of anti-VZV antibody
Measured by fluorescent antibody to the membrane antigen (FAMA).
Click on the lead sponsor to view all of their trials.
