PACTR202306534727467招募中2 期
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 125
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. Able and willing to complete and provide written informed consent prior to any study procedure; completing an AoU prior to enrollment by answering 9 out of 10 questions correctly at least once in 3 attempts, and including optional consent for retention of blood samples for potential future testing and assay development.
- •2. Able to read and write the language used in diary card. 3. Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informed consent.
- •4. Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits.
- •5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- •6. Has a means to be contacted and to contact the investigator during the study.
- •7. Agree not to receive any vaccine within 28 days from study vaccination (prior and after), with the exception of an emergency use authorization or authorized non-adenoviral vectored COVID-19 vaccine, which may be given within 14 days of study vaccination.
- •8. Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination.
- •9. In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by the principal investigator.
- •10. Clinical laboratory results within 28 days prior to vaccination within the site's laboratory reference ranges (or deemed not clinically significant by the principal investigator).
- •11. Has a BMI >17 and =37 at screening.
- •Female & Male participant specific criteria detailed in protocol excluding pregnancy and child birth through defined study periods.
排除标准
- •1. Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
- •2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that listed in the study protocol.
- •3. Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1 and 2, syphilis).
- •4. Known prior exposure to MARV or prior diagnosis of MVD.
- •5. Current diagnosis of COVID-19 by RT-PCR or antigenic testing or current signs and symptoms of COVID-19. Participants may be enrolled 14 days post resolution of all signs and symptoms of COVID-19 or of testing positive for COVID-19 in asymptomatic participants.
- •6. History of or active status of any of the following clinically significant conditions (full list provided in study protocol).
- •7. Has a clinically significant acute illness (this does not include minor illnesses) or temperature =38.0°Celsius (=100.4° Fahrenheit) within 24 hours of the planned dose of study vaccine, re-evaluation of eligibility may be performed at resolution of all signs and symptoms, and randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor (as appropriate).
- •8. Receipt of any of the specific substances list in the protocol.
- •9. Use of immunomodulators or systemic glucocorticoids in daily doses of glucocorticoid equivalence >20 mg of prednisolone in the last 90 days, and for periods exceeding 10 days. NSAIDS are permitted.
- •10. Receipt of blood products within 3 months prior to enrollment.
- •11. Current anti-tuberculosis prophylaxis or therapy.
- •12. Abnormality or permanent body art (such as tattoo) in deltoid region that would interfere with ability to observe or assess injection site reactions.
研究者
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