Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Herpes Zoster
About this trial
This is an interventional prevention trial for Herpes Zoster
Eligibility Criteria
Inclusion Criteria: Permanent residents aged 30 years and above; Subjects voluntarily agree to participate in the study and signed an informed consent; Be able to participate in all scheduled visits and comply with the protocol requirements. Exclusion Criteria: Axillary temperature>37.0℃; History of herpes zoster within 5 years before vaccination; Prior vaccination with chickenpox vaccine or herpes zoster vaccine; Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination; Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination; Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination; Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination; History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history; Asplenia or functional asplenia, or splenectomy caused by any condition; Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases; Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable; Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication; History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg); Current or history of alcohol and/or drug abuse; Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
Sites / Locations
- Yanjin Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Active Comparator
Placebo Comparator
Low dose vaccine group in adults aged 30 to 49 years
High dose vaccine group in adults aged 30 to 49 years
Placebo group in adults aged 30 to 49 years
Low dose vaccine group in adults aged 50 years and older
High dose vaccine group in adults aged 50 years and older
Shingrix® group in adults aged 50 years and older
Placebo group in adults aged 50 years and older
Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).