Herpes zoster
Conditions
Interventions
Trial group1:One dose (0.5 mL) of the recombinant herpes zoster vaccine (low-dose antigen + low-dose adjuvant) was administered intramuscularly in the deltoid muscle of the upper arm on Day 0 and Day
Trial group2:One dose (0.5 mL) of the recombinant herpes zoster vaccine (low-dose antigen + high-dose adjuvant) was administered intramuscularly in the deltoid muscle of the upper arm on Day 0 and Day
Trial group3:One dose (0.5 mL) of the recombinant herpes zoster vaccine (high-dose antigen + low-dose adjuvant) was administered intramuscularly in the deltoid muscle of the upper arm on Day 0 and Da
Trial group4:One dose (0.5 mL) of the recombinant herpes zoster vaccine (high-dose antigen + high-dose adjuvant) was administered intramuscularly in the deltoid muscle of the upper arm on Day 0 and Da
Positive control vaccine group:One dose (0.5 mL) of the recombinant herpes zoster vaccine (containing 50 µg of gE protein plus the AS01B adjuvant system) was administered intramuscularly in the deltoi
Placebo control group:One dose (0.5 mL) of the placebo was administered intramuscularly in the deltoid muscle of the upper arm on Day 0 and Day 60, respectively.
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Residents aged 40 years and older (at the time of screening), regardless of gender; 2. Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form; 3. Participants are able to attend all planned follow-up visits and comply with the protocol requirements; 4. 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.
Exclusion criteria
Exclusion criteria: 1. Axillary temperature >= 37.0°C; 2. History of herpes zoster before vaccination with the investigational vaccine; 3. Previous vaccination against HZ or varicella; 4. Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine; 5. Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days; 6. Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period; 7. Individual with the following diseases: (1) Have acute diseases or are in the acute exacerbation period of chronic diseases, or take antipyretic, analgesic, and anti-allergic drugs within 3 days before vaccination; (2) Allergies to any component of the study vaccine, or have a history of severe allergic reactions to any vaccination; (3) History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc. causing brain nerve tissue damage, etc.) and mental illness, or a family history of mental illness; (4) Asplenia, or functional asplenia; (5) Primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; (6) Chronic administration (>=14 consecutive days) of glucocorticoid (reference value for dose: >= 2mg/kg/day or >= 20mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (= 140mmHg and/or diastolic blood pressure >= 90mmHg); 8. Those tested positive for antibodies to the Human Immunodeficiency Virus (HIV) at screening.; 9. History of long-term alcohol abuse (Note: For men, an average of >= 15 standard drinks per week; for women, an average of >= 8 standard drinks per week. One standard drink contains 14 g of alcohol, equivalent to approximately 360 ml of beer, 45 ml of spirits with 40% alcohol, or 150 ml of wine.) and/or drug abuse; 10. Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study; 11. Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination; 12. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration of anti-gE antibody one month after full immunization;Geometric mean titer of anti-VZV antibody one month after full immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events (AEs) occurring within 30 minutes after each dose, solicited AEs from 0–7 days after each dose, and unsolicited AEs from 0–30 days after each dose.;The incidence of serious adverse event from the first dose to 12 months after the full vaccination;The incidence of adverse event of special interest from the first dose to 12 months after the full vaccination;Seroconversion rate of anti-gE antibody and anti-VZV antibody one month, six months and twelve months after full immunization;Geometric mean concentration of anti-gE antibody six months and twelve months after full immunization;Geometric mean titer of anti-VZV antibody six months and twelve months after full immunization;The frequency of antigen-specific CD4/CD8 T cells expressing at least two activation markers (TNF-a, IFN-?, IL-2, or CD40L).;Geometric mean fold rise of anti-gE antibody and anti-VZV antibody one month, six months and twelve months after full immunization;The cellular response rate of antigen-specific CD4/CD8 T cells expressing at least two activation markers (TNF-a, IFN-?, IL-2, or CD40L).;Geometric mean concentration of anti-gE antibody two months after first vaccination;Geometric mean titer of anti-VZV antibody two months after first vaccination;Seroconversion rate of anti-gE antibody and anti-VZV antibody two months after first vaccination;Geometric mean fold rise of anti-gE antibody and anti-VZV antibody two months after first vaccination; | — |
Countries
China
Contacts
Public ContactHuang Tao
Hunan Provincial Center for Disease Control and Prevention
Outcome results
None listed