PACTR202006922165132已完成1 期
COVID-19: An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARSCoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2,000
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
- •Healthy adults aged 18-65 years.
- •Documented result of not being infected with HIV (including screening by a rapid HIV antibody test) within two weeks of randomization into the study
- •for Group-1 and Group-2 participants only.
- •Able and willing (in the Investigator’s opinion) to comply with all study requirements.
- •Willing to allow investigators review available medical records, and review all medical and laboratory records if participant is admitted to hospital with
- •respiratory tract infection suspected or confirmed to be COVID-19.
- •For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s)
- •of screening (within 14 days of randomization) or vaccination.
- •For Group-3 only (i.e. HIV-infected), need to have been on anti-retroviral treatment for at least three months and HIV-1 viral load is <1,000 copies/ml
- •within two weeks of randomization.
- •Agreement to refrain from blood donation during the course of the study.
- •Provide written informed consent.
排除标准
- •Planned receipt of any vaccine other (licensed or investigational) than the study intervention within 30 days before and after each study vaccination.
- •Use of any unproven registered and unregistered treatments for COVID-19.
- •Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any
- •coronavirus vaccines).
- •Administration of immunoglobulins and/ or any blood products within the three months preceding the planned administration of the vaccine
- •HBSAg positivity on the screening sample.
- •Grade 2 or higher level of abnormality for FBC, U&E or LFT based on DAIDS Grading Criteria (Version 2.1, July 2017)
- •History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 vaccine.
- •Any history of hereditary angioedema or idiopathic angioedema.
- •Any history of anaphylaxis in relation to vaccination.
- •Pregnancy, lactation or willingness/intention to become pregnant during the study.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition likely to affect participation in the study.
- •Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or
- •venipuncture.
- •Any other serious chronic illness requiring hospital specialist supervision.
- •Chronic respiratory diseases, including asthma
- •Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
- •Seriously overweight (BMI = 40 Kg/m2)
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
- •Suspected or known injecting drug abuse in the 5 years preceding enrollment.
- •Any clinically significant abnormal finding on screening urinalysis.
- •Any other significant disease
研究者
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