PACTR202009726132275已完成2 期
A Phase 2A/B, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adult Subjects Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV. COVID-19
ovavax Inc0 个研究点目标入组 4,704 人开始时间: 2020年8月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,704
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •All subjects:
- •Body mass index (BMI) of 17 to 40 kg/m².
- •Provides informed consent prior to study participation and is willing to comply with study procedures, including potential home visits.
- •Women of child-bearing potential must agree not to have sexual intercourse with men, or must consistently use an agreed method of contraception from at least 21 days prior to enrolment in the study, through 6 months after the last vaccination.
- •HIV-negative subjects only:
- •Documentation of HIV-negative test result by a method approved in South Africa.
- •Healthy at study screening, as determined by the investigator.
- •HIV-positive subjects only:
- •Documentation of HIV-positive test result by a method approved in South Africa.
- •Receiving highly active antiretroviral therapy (HAART) and has been using the same regimen for at least 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks of entering the study are allowed, as are exchanges in pharmacological formulations.
- •Medically stable at screening, as determined by the investigator.
- •Have a HIV-1 viral load < 1000 copies/mL within 45 days of randomization in the stud
排除标准
- •Any current acute illness requiring medical or surgical care, or chronic illness (excluding HIV in HIV-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable.
- •Chronic disease, including:
- •a. hypertension (elevated blood pressure [BP]) = grade 2 (systolic BP = 160 mmHg; and/or diastolic BP = 100 mmHg) according to the South African Hypertension Society’s Practice Guidelines;
- •b. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years;
- •c. chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the past 2 years. Stable coronary heart disease is NOT exclusionary;
- •d. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator;
- •e. asthma requiring regular/chronic control medication;
- •f. Type 1 and 2 diabetes (adult onset) requiring treatment with insulin;
- •g. chronic kidney disease/renal insufficiency;
- •h. Chronic gastrointestinal and hepatic diseases;
- •i. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, neuropathy, epilepsy, or a history of stroke or previous neurological disorder within the past 12 months with residual symptoms). Subjects with a history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded.
- •Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
- •Prior receipt of investigational or approved COVID-19 vaccine at any time.
- •History of a diagnosis of suspected or confirmed COVID-19.
- •Received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first st
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