TCTR20220804007已完成2 期
A Phase 2 Double-blind, Randomized, Controlled Trial to Assess the Safety and Immunogenicity of 10 mcg HXP-GPOVac Vaccine in Healthy Volunteers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
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
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Male or female age 18-75 years old.
- •2.Has never received any COVID-19 vaccine before.
- •3.Has negative COVID-19 test result.
- •4.Has a body mass index (BMI) of 17 to 30 kg/m2
- •5.Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
- •6.If a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP.
- •7.Be able to read and write in Thai and willing to sign an informed consent form.
- •8.Resides in the study site area and is able and willing to adhere to all protocol visits and procedures.
排除标准
- •1.Use of any investigational medicinal product of any non-study vaccine within 90 days prior to randomization or planned use of such a product during the period of study participation.
- •2.History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination during the course of study participation.
- •3.Has positive COVID-19 test result or history of COVID-19 infection.
- •4.Previous receipt of an investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on the interpretation of the trial results.
- •5.History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine.
- •6.History of chicken or egg allergy.
- •7.History of angioedema after receiving any medication that could lead to TEN anaphylaxes.
- •8.History of Anaphylaxis from any causes (known or unknown)
- •9.Acute illness (moderate or severe) and/or fever (body temperature measured orally greater than or equal to 38.0 Celsius ).
- •10.Any abnormal vital sign deemed clinically relevant by the PI.
- •11.Abnormality grade 3 severity or more in screening laboratory test (see detail in appendix B).
- •12.A positive serologic test for human immunodeficiency virus (HIV Ab), hepatitis B (HBsAg), or hepatitis C (HCV Ab).
- •13.History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.
- •14.Any confirmed or suspected immunosuppressive or immunodeficient state.
- •15.Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.
- •16.Administration of any long-acting immune-modifying drugs (example: infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to the first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to greater than or equal to 0.5 mg/kg/day of prednisolone; the use of topical steroids including inhaled and intranasal steroids is permitted).
- •16.History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (example: thalassemia, coagulation factor deficiencies).
- •17.Recent history (within the past year) or signs of being an alcoholic with a high-risk level (13 scores or more, according to the alcoholic questionnaire by The Department of Mental Health)
- •18.Any medical, psychiatric or behavioral condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
- •19.Employee of any person employed by the sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
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