Herpes Zoster
Conditions
Interventions
Phase I trial vaccine group 1:Vaccination
Phase I trial vaccine group 2:Vaccination
Phase I control group 2:Vaccination
Phase II trial vaccine group 2:Vaccination
Phase II trial vaccine group 1:Vaccination
Phase II positive control group:Vaccination
Phase I control group 4:Vaccination
Phase II placebo group:Vaccination
Phase I control group 1:Vaccination
Phase I control group 3:Vaccination
Sponsors
Hubei Center For Disease Control And Prevention
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 40 years on the day of enrollment, gender-neutral; 2.Proof of legal identity can be provided; 3.Ability to understand trial procedures and sign a written informed consent form indicating agreement to participate in the trial; 4.Ability to attend all scheduled follow-up visits and to comply with all trial procedures (e.g., complete diary cards, return for visits); 5.Temperature <37.3°C (axillary temperature) on the day of enrollment; 6.Chronic patients need to be in the stabilization phase of their chronic disease; 7.Female subjects of childbearing age and male subjects agree to use strict and effective contraception from the start of the trial until 6 months after the full course of vaccinations;
Exclusion criteria
Exclusion criteria: 1.People with a previous history of shingles; 2.revious history of chickenpox or shingles vaccination; 3.History of close contact with patients with varicella or herpes zoster in the previous 2 years; 4.Women of childbearing age who have a positive urine pregnancy test, who are breastfeeding, pregnant, or who plan to become pregnant within 6 months from the start of the test to the full course of vaccination; 5.Allergy to any component of the vaccine (history of allergy to any previous vaccination), or history of other severe allergies; 6.Use of immunoglobulin and/or any blood product within 3 months prior to the administration of the trial vaccine, or planned use during the trial period; 7.Have taken antipyretic, analgesic, or antiallergic medications within 72 hours prior to receiving the experimental vaccine; 8.Used any experimental or unregistered product (drug, vaccine, biologic, or device) other than the test vaccine within 1 month prior to administration of the test vaccine, or plan to use it during the test period; 9.Non-live vaccine administered within 7 days prior to the experimental vaccine or live vaccine administered within 14 days prior to the experimental vaccine; 10.Have a serious medical condition that prevents them from completing the entire trial; 11.Received immunosuppressive therapy or other immunomodulatory drugs, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20 mg/day, or used for more than 15 days), or monoclonal antibodies, or thymic peptides, or interferon, etc., within 6 months prior to the experimental vaccine, or are scheduled to receive such therapy between the first dose of the vaccine and 1 month after the full course of immunization, except that topical applications are permitted (e.g., ointments, eye drops, inhalations, or nasal sprays). such as ointments, eye drops, inhalers, or nasal sprays); 12.Chemotherapy and radiotherapy for the treatment of cancer or other diseases, as well as treatments related to organ and bone marrow transplantation; 13.Diseases or medical treatments that result in immunodeficiency, such as congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ and bone marrow transplants, leukemia, lymphoma, Hodgkin's disease, multiple myeloma or malignant neoplasms, and absence of spleen or splenectomy; 14.Those who are suffering from serious infectious diseases such as active tuberculosis, active viral hepatitis, etc; 15.Moderate or severe acute illness/infection (at the investigator's discretion) or febrile illness (axillary temperature >=37.3°C) within 72 hours prior to vaccination; 16.Known thrombocytopenia, any history of coagulation disorders or on anticoagulant therapy, etc; 17.Serious cardiovascular disease (myocardial infarction, pulmonary heart disease, hypertension that cannot be controlled by medication (40-64 years old: systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg; >=65 years old: systolic blood pressure>=150 mmHg and/or diastolic blood pressure >=90 mmHg)), pulmonary edema, serious liver or kidney disease, and diabetes mellitus that cannot be controlled by medication; 18.Prior history of mental and neurological disorders (e.g., depression, epilepsy, or history of convulsions); or family history of psychiatric disorders; 19.Currently suffering from various severe infectious, suppurative and allergic skin diseases; 20.Plans to move before the end of the trial or to leave the l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of special interest(AESI)Phase I and II;adverse event(AE)Phase I and II;Blood Biochemistry Phase I;Anti-gE antibody GMC Phase II;Anti-VZV antibody GMT Phase II;Complete Blood Count Phase I;Urinalysis Phase I;Coagulation Four Items Phase I;Anti-gE Antibody Positivity Rate Phase II;Anti-VZV Phase II; | — |
Secondary
| Measure | Time frame |
|---|---|
| serious adverse event(SAE)Phase I and II;GMT/GMC Phase I;Seroconversion rate Phase I;Cellular immunity level Phase II;Cellular immunity level Phase I;Anti-gE Antibody Positivity Rate Phase I;Anti-VZV Phase I; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Center For Disease Control And Prevention
Outcome results
None listed