PACTR202108781239363招募中1 期
A Phase 1 Randomized, Blinded, Placebo Controlled, Dose-Escalation and Dosing Regimen Selection Study to Evaluate the Safety and Immunogenicity of rVSV-Vectored Lassa Virus Vaccine in Healthy Adults at Multiple Sites in West Africa
Emergent Product Development Gaithersburg Inc0 个研究点目标入组 108 人开始时间: 2021年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
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. Subject understands the study as outlined in the informed consent form (ICF) and its procedures, agrees to study-related assessments, study visits, and voluntarily provides informed consent by signing the ICF.
- •2. Age: 18 to 50 years (inclusively).
- •3. Body mass index (BMI) of 18 to 30 kg/m2 at Screening Visit.
- •4. Hearing threshold between -10 to 15 decibels (dB) across low, middle, and high frequencies as measured by audiometry.
- •5. Generally healthy, in the opinion of the Investigator, based on medical history, physical examination and screening laboratory assessments.
- •6. Women who are EITHER:
- •i. Not of childbearing potential (CBP): anatomically sterile, or post-menopausal (defined as elevated FSH and =12 months without menses).
- •ii. Meet all the below criteria:
- •Negative serum pregnancy test at Screening Visit.
- •Negative urine pregnancy test immediately prior to dosing at Day 1.
- •Do not intend to become pregnant during the study.
- •Using one of these medically acceptable methods of contraception (if woman of CBP) for the duration of participation, such as:
- •Hormonal contraceptives (e.g., implants, pills, patches [combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine hormone-releasing system]) initiated =30 days prior to dosing.
- •Intrauterine device (IUD) inserted =30 days prior to dosing.
- •Bilateral tubal ligation.
排除标准
- •1. Currently pregnant or lactating.
- •2. Laboratory evidence of infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (HBV or HCV).
- •3. History of cardiac disease.
- •4. History of severe allergic reaction or anaphylaxis.
- •5. History of any immunodeficiency or immunocompromising condition that could impact response to IP administration.
- •6. Receipt or anticipated receipt of blood products from 180 days prior to screening to 30 days post IP administration.
- •7. Current or past participation in a study with an IP from 30 days prior to screening through study duration.
- •8. Receipt or anticipated receipt of any vaccines or systemic immunomodulatory agents from 30 days prior to screening to 90 days post IP administration.
- •9. Evidence of current or past (over the past 5 years) use or treatment for alcohol or drug abuse.
- •10. Planned medical procedure during the study.
- •11. Medical condition that, in the opinion of the Investigator, could adversely impact the subject.
- •12. Chronic or acute severe neurologic condition
- •13. Clinically significant medical condition or laboratory assessment.
- •14. Abnormal clinically significant electrocardiogram (ECG) at screening.
- •15. Acute condition not resolved at least 14 days prior to IP dosing.
- •16. History of LASV infection/disease.
- •17. Prior residence greater than 30 days in a LASV-endemic region.
- •18. Prior receipt of any investigational LASV vaccine.
- •19. Prior receipt of a VSV-vectored Ebola virus vaccine.
- •20. Prior known infection with VSV.
- •21. History of hearing loss.
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