PACTR201411000919191Other1 期
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV¿G-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Lambaréné, Gabon.
niversitaetsklinikum Tuebingen0 个研究点目标入组 60 人开始时间: 2014年10月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 60
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
- 6 Year(s) 至 50 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or non-pregnant, non-lactating female, ages 6 to 50 (inclusive) at the time of screening
- •Have provided written informed consent prior to screening procedures
- •Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
- •Available, able, and willing to participate for all study visits and procedures
- •Negative pregnancy-test for female volunteers
- •Females, of childbearing potential, who are willing to use of the study effective methods of contraception during 30 days after vaccination.
- •- A woman is considered of childbearing potential unless post-menopausal (¿ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
- •- Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label for example:
- •* Oral contraceptives, either combined or progestogen alone,
- •* injectable progestogen,
- •* implants of etenogestrel or levonorgestrel,
- •* oestrogenic vaginal ring
- •* percutaneous contraceptive patches,
- •* intrauterine device or intrauterine system,
- •* male partner sterilisation at least 6months prior to the female subject¿s entry into the study, and the relationship is monogamous,
- •* male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository).
- •* male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
- •Be willing to minimize blood and body fluid exposure of others days after vaccination
- •- Be advised to use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse 30 days after vaccination
- •- Avoiding the sharing of needles, razors, or toothbrushes
- •- Avoiding open-mouth kissing
排除标准
- •History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- •Known allergy to the components of the BPSC1001 vaccine product
- •Ongoing participation in another clinical trial
- •Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)
- •Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test (including sickle cell anemia)
- •Viral Serologies (HBsAg, anti-HCV Ab, anti-HIV)
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes requiring medication
- •Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
- •Have a known history of Guillain-Barré Syndrome
- •Have an active malignancy or history of metastatic or hematologic malignancy
- •Suspected or known alcohol and/or illicit drug abuse within the past 5 years
- •Moderate or severe illness and/or fever >38°C within 1 week prior to vaccination
- •Pregnant or lactating female, or female who intends to become pregnant 30 days after vaccination
- •Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
- •History of blood donation within 30 days of enrollment or plans to donate within the study period
- •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
- •- For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
- •- Intranasal and topical steroids are allowed
- •Any other significant finding that in the opinion of the investigator would increase the risk to the individual.
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