A Study to Evaluate Safety and Tolerability of a Recombinant Herpes Zoster Vaccine
Herpes Zoster, Vaccine-Preventable Diseases
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster, Vaccine
Eligibility Criteria
Inclusion Criteria: Males and females able to provide legal identity certificate, aged 50 to 70 years inclusive at the time of signing the ICF; Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF; Subjects are healthy or have well controlled mild medical conditions as determined by the investigator; Female subjects are not pregnant or lactating. Female subjects with childbearing potential* should take reliable contraceptive measures**, and have no pregnancy and fertility plan within 7 months; *Female subjects of childbearing potential are defined as sexually mature women: 1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; 2) have had natural menses at any time in the preceding 12 consecutive months (without an alternative medical cause). Post-menopausal should be confirmed with FSH and Estradiol levels. **Reliable, medically acceptable forms of contraception: For 3 months prior to screening - hormonal contraceptive (e.g., oral, patch, injectable, depot or vaginal ring), or implantable device (implantable rod or intrauterine device), or For at least 1 month prior to screening - a double barrier method (e.g., diaphragm, cervical cap, or condom in conjunction with spermicide or sponge), or Subjects of reproductive age that are abstinent are acceptable provided they agree to a double barrier method should they become sexually active during the study. and subjects agree to continue birth control for at least 7 months. Able to attend all scheduled follow-up visits and able to comply with protocol requirements; Oral temperature < 37.5℃/99.5℉. Exclusion Criteria: Subjects with a personal history or family history of convulsion, epilepsy, encephalopathy, and psychosis; Subjects who received immunosuppressive therapy within 3 months before vaccination (e.g., long-term use of systemic glucocorticoids for ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalence); Allergic to any component of the investigational vaccine, or have a history of a severe allergy to any vaccination; Impaired immune function or diagnosed with congenital or acquired immunodeficiency disease, positive serology for Hepatitis B Surface Antigen, Hepatitis C Antibody and human immunodeficiency virus (HIV); History of varicella or herpes zoster vaccination; History of HZ; Received an inactivated or recombinant vaccine within 14 days or any live vaccine within 28 days prior to vaccination; Subjects who have acute diseases within 3 days before vaccination, or acute stage or exacerbation of chronic diseases within 1 month before vaccination; Subjects with tattoos to the upper arm deltoid area or have infectious skin disease; History of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection; History of asplenia or functional asplenia, and asplenia or splenectomy due to any condition; Subjects with ≥ Grade 2 laboratory abnormalities and Grade 1 laboratory abnormalities that the investigator consider clinically significant; Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study; Any conditions that in the opinion of the investigator may affect subject safety or assessments (disease factors such as extensive psoriasis, unexplained skin rash, eczema, chronic pain syndrome, or social factors such as plans to move elsewhere before the end of the study). A positive screen for alcohol, drugs of abuse at screening period and Day 0 (before vaccination).
Sites / Locations
- Frontage Clinical Services, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Cohort1: Low dose sentinel group
Cohort2: High dose sentinel group
Cohort3: Low dose main group
Cohort4: High dose main group
Three subjects will be first enrolled into low dose sentinel group in open-label, prior to initiation of dosing in each dose level main group.
After reviewing the safety through 7 days after the first dose of LZ901, if no safety signals occur, another 3 subjects will be enrolled into high dose sentinel group in open-label.
If also no safety signals occur through 7 days after the first dose of LZ901 in high dose sentinel group, 30 subjects will be randomized in a 2:1 ratio to receive two doses of LZ901 or placebo in a double-blind fashion in low dose main group.
Subjects will be enrolled in high dose main group also after the safety review through 7 days after the first dose of LZ901 or placebo in low dose main group.