ACTRN12623000947606进行中（未招募）Unknown
A Single-center, Randomized, Double-blind, Placebo- and Positive-controlled Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Zoster Vaccine (CHO) in Healthy Adults
Bestudy Australia Pty Ltd0 个研究点目标入组 100 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1)Healthy men or women aged 30 to 70 years.
- •2)Able to fully understand and voluntarily sign the informed consent form ICF.
- •3)Able to comply with the requirements for the clinical research protocol to complete the trial.
- •4)Females of childbearing potential must agree not to become pregnant from signing the ICF and through 6 months after the last vaccination. Men and women of childbearing potential must agree to use contraception from signing the ICF and through 6 months after the last vaccination
- •OR be defined as not of childbearing potential
- •5). Female subjects of childbearing potential, must have a negative pregnancy test at screening, and negative urine pregnancy test at D1, and are not lactating and agree not to breastfeed up to 6 months post full vaccination.
- •6).Male participants must be vasectomized or agree to wear a condom during intercourse with a women of child bearing potential (WOCBP). Male participants must inform their female partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner.
排除标准
- •Exclusion criteria for first dose
- •1)A history of herpes zoster.
- •2)Subject has received any varicella zoster vaccine or herpes zoster vaccine or planning to take those vaccines during the study.
- •3)Any clinically significant allergic history, including to any vaccine or vaccine-related component, such as urticaria, difficulty breathing, or angioneurotic edema, or any clinically significant allergic reactions.
- •4)Received any immunosuppressive therapy (e.g. long-term application of systemic glucocorticoids greater than or equal to 14 days, with dose greater than or equal to 2 mg/kg/day or greater than or equal to 20 mg/day of prednisone or equivalent dose of prednisone dose) within 3 months before dosing (excluding administration of inhaled, intra-articular, and topical steroids); receipt of whole blood or blood products within 3 months before vaccination or plan to use them during the study period.
- •5)Previous vaccination with any vaccine within 30 days before each vaccination or planning to take any vaccine 30 days after each vaccination.
- •6)History of convulsions, epilepsy, encephalopathy (e.g. congenital cerebral hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, cerebral nerve tissue damage caused by chemical drug poisoning, etc.); clinically significant history of psychiatric disease or family history of bipolar disorder, schizophrenia.
- •7)History of malignancy [excluding basal cell carcinomas (BCC) and squamous cell carcinomas (SCC)] within 5 years prior to randomization
- •8)Asplenia or functional asplenia, or splenectomy caused by any circumstances.
- •9)Presence of primary or secondary immunodeficiencies or have been diagnosed with congenital or acquired immunodeficiency, infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease (IBD), or other autoimmune disease.
- •10)Has severe cardiovascular diseases (pulmonary heart disease, pulmonary edema), severe liver or renal diseases, chronic obstructive pulmonary; uncontrolled diabetes [hemoglobin A1c (HbA1c) >9.0%].
- •11)History of thrombocytopenia or other coagulation disorders which may be contraindications for an intramuscular injection.
- •12)Abnormal blood pressure in sitting position at any time points during screening and before the first vaccination (systolic pressure greater than or equal to 145 mmHg and/or diastolic pressure greater than or equal to 95 mmHg).
- •13)History of fever within 3 days before the first dose (tympanic temperature greater than 37.5 degree celsius) or have suffered acute diseases requiring systemic application of antibiotics or antiviral therapy or in the acute phase of chronic infection within 7 days before vaccination.
- •14)Any laboratory values out-of-range at the investigator’s discretion, or with clinical significance as judged by the investigator.
- •16)Positive serology test results for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, syphilis treponema pallidum (S-TP) antibody, Hepatitis B core antibody (HBcAb) or hepatitis B virus surface antigen (HBsAg) test at screening.
- •17)Those who have a history of alcoholism or excessive drinking (14 units/week for female and 21 units/week for male. 1 unit = 285 mL beer, or 25 mL liquor, or 100 mL wine) within 6 months prior to dosing or have a positive result in alcohol breath test.
- •18)Subject does not have one suitab
研究者
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