PACTR202407764378004尚未招募4 期
EbolaCov: A phase IV, single-centre, single-blinded, randomized controlled trial to assess safety and immunogenicity of rVSV?G-ZEBOV-GP vaccination when dosed concurrent with mRNA COVID-19 vaccine booster doses in healthy African adults.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 72
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 male and female adults between ages 18-50 years, who are able and willing to provide written informed consent and will comply with the study requirements.
- •Already completed a primary course of COVID-19 immunisation (any WHO approved primary immunisation course is acceptable).
排除标准
- •Unwilling or unable to provide written informed consent to take part
- •Unwilling or unable to comply with study procedures
- •Previously received an Ebola vaccine or previous exposure to Ebola virus (including serological and clinical diagnoses, irrespective of viral strain)
- •Not received a primary course of COVID-19 immunisation
- •History of any suspected or confirmed disorder of the immune system that, in the opinion of the Investigators, might impair the results of the study
- •Use of immunosuppressant medication within the past 6 months (excluding topical steroids or oral steroid courses lasting <7 days)
- •Current diagnosis or treatment of cancer (unless non-melanomatous skin cancer)
- •Have a bleeding disorder deemed significant by study doctor
- •Pregnant or breast-feeding females
- •Able to avoid close contact with vulnerable individuals, including via high-risk blood and bodily fluids for 6 weeks following vaccination to reduce the risk of transmission to vulnerable individuals (e.g. immuno-compromised individuals, individuals receiving immunosuppressive
- •therapy, pregnant or breast-feeding women, children <1 year of age).
- •Unable to prevent contact of their blood or bodily fluids with farm animals in the 6 weeks following vaccination
- •Plan to donate blood in the 6 weeks following vaccination
- •Hypersensitivity to any active substances, excipients, or rice protein.
- •History of anaphylaxis to any component of vaccine formulation.
研究者
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