PACTR202202526350870尚未招募1 期
A Phase I study to Evaluate the Tolerability, Safety, and Immunogenicity of a PIKA-Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine in Healthy Adults
Yisheng Biopharma Singapore Co Ltd0 个研究点目标入组 90 人开始时间: 2022年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Age = 18 years on Study Day 0.
- •2.Judged by the investigator to be healthy on the basis of medical history, physical examination and vital signs performed at screening.
- •3.Able to provide informed consent form.
- •4.Able and willing to comply with all study procedures over follow-up period of approximately 14 months.
- •5.Axillary body temperature = 37.0?.
- •6.Sars-cov-2 test was negative for throat swabs by RT-PCR.
- •7.Female of non-pregnancy (negative pregnancy test), non-lactation.
- •8.For female subjects with childbearing potential: must agree to avoid pregnancy starting after screening until 90 days after receiving the last vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.
- •9.Male subjects who are sexually active with a woman of childbearing potential and have not had vasectomy must agree to practice a highly effective form of contraception with their female partners of childbearing potential during the trial, starting after screening until 90 days after receiving the last vaccination.
- •10.Men must be willing to refrain from sperm donation, starting after screening until 90 days after receiving the last vaccination.
排除标准
- •1.Abnormal vital sign or laboratory test prior to D0 judged as clinically significant by investigator.
- •2.Known allergic, hypersensitive, or intolerant to the test vaccine (including any excipients).
- •3.History of severe allergies to any drugs, foods or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.
- •4.Diagnosed with any serious disease, or chronic disease, or congenital malformation, that may influence the compliance with the study including but not limited to respiratory disease such as asthma or chronic bronchitis, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergy, etc.
- •5.History or family history of convulsions, seizures, encephalopathy, and mental illness.
- •6.History of narcolepsy.
- •7.Known substance abuse and addiction through medical history.
- •8.Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0.
- •9.Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0.
- •10.Blood loss > 400 mL within 28 days prior to D0 (e.g., donated blood or blood products or injury), or planned to donate blood or plasma before D49 of the study.
- •11.Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0.
- •12.Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea.
- •13.Contraindications to intramuscular injection, such as thrombocytopenia, any clotting disorder, or treatment with anticoagulants.
- •14.Any abnormalities or permanent body art (such as tattoos) at the injection site that may influence the investigator to observe the local reactions of the injection site.
- •15.Received any vaccines within 28 days prior to D0 or disagree to avoid receiving any vaccines before D49 of
研究者
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