A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV¿G-ZEBOV) Ebola Virus Vaccine Candidate.
- Conditions
- Ebola
- Registration Number
- PACTR201411000919191
- Lead Sponsor
- niversitaetsklinikum Tuebingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method