Ebola
Conditions
Interventions
BPSC1001 (VSV¿G-ZEBOV)
BPSC1001 (VSVdG-ZEBOV)
Sponsors
Universitaetsklinikum Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Reactogenicity;Immunogenicity;long term safety and immunogenicity;¿ Determination of B-cell and T-cell repertoire before and after vaccination | — |
Countries
Gabon
Contacts
Public ContactJessica Brosnahan
Project Manager
Outcome results
None listed