PACTR202006896481432已完成2 期
A Phase 2b randomized, open-label, controlled, single center study in Plasmodium falciparum-infected and uninfected adults age 18-55 years old in Kenya to evaluate the efficacy of the delayed, fractional dose RTS,S/AS01E malaria vaccine in subjects treated with artemisinin combination therapy plus primaquine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 619
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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed or thumb printed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female between 18 and 55 years of age, inclusive
- •In good general health as evidenced by medical history and clinical examination before entering the study
- •Ability to take oral medication and be willing to adhere to the medication regimen
- •For females, she must be of non-childbearing potential or use appropriate measures to prevent pregnancy for 30 days prior to vaccination through 2 months after completion of the vaccine series. Non-childbearing potential means she is surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera). Kombewa clinical staff will assist with provision of acceptable birth control for study entry and will discuss with volunteer at screening visit.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Planned administration/administration of a vaccine not foreseen by the study protocol from within 30 days before the first dose of study vaccine until 30 days after the last dose of study vaccine. In the context of the COVID-19 pandemic, the administration of the COVID-19 vaccine will be allowed as an exception to this exclusion criteria as follows. The study team will work with the participant to attempt to have any COVID-19 vaccine administration occur 30 days or more before or after study vaccinations. When this is not possible, COVID-19 vaccination will be allowed 10 days or more before or after study vaccination. Intervals shorter than 10 days can be allowed on a case-by-case basis in discussion with the sponsor.
- •Any prior receipt of any rabies vaccine or experimental malaria vaccine.
- •Confirmed or suspected significant immunosuppressive or immunodeficient condition as determined by the investigator, including clinical stage 3 or 4 human immunodeficiency virus (HIV) infection (Appendix G).
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.
- •History of any neurologic disorders.
- •Acute disease (defined as the presence of a moderate or severe illness with or without fever), including acute malaria, at the time of enrolment. All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e. Oral temperature < 37.5°C. Individuals excluded with acute disease, including acute malaria, can become eligible again after complete recovery of the illness, including appropriate treatment as applicable, and can be rescreened at a later date.
- •Acute or chronic, clinically significant pulmonary, cardiovascular (including cardiac arrythmias) , hepatic or renal functional abno
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