Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)

This is an interventional treatment trial for Hemorrhagic Fever, Ebola focused on measuring Ebola virus, vaccination, phase I, healthy volunteers Read More

Inclusion Criteria:

• Ability to understand the subject information and to personally sign the informed consent
• Provided written informed consent.
• Healthy females and males aged 18 - 55 years .
• No clinically significant health problems
• Body mass index 18.5 - 30.0 kg/m2 and weight >50 kg at screening.
• Females of childbearing potential who agree to comply with the applicable contraceptive requirements of the protocol or females who are permanently sterilized.
• Males who agree to comply with the applicable contraceptive requirements of the protocol
• Subjects must be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
• Be willing to refrain from blood donation during the course of the study.
• The subject is co-operative and available for the entire study.

Exclusion Criteria:

• Prior receipt of an Ebolavirus or Marburgvirus vaccine or VSV-vectored vaccine.
• Receipt of any vaccine in the 2 weeks prior to the trial vaccination (4 weeks for live vaccines) or planned receipt of any vaccine in the 3 weeks following the trial vaccination.
• Known allergy to the components of the BPSC1001 vaccine product or history of life-threatening reactions to vaccine containing the same substances.
• Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational drug -prior to receiving the first dose within this study
• Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product under investigation.
• Any positive result for HIV1/2, HCV antibody or HBs antigen testing.
• Pregnant or lactating females, or females who intend to become pregnant during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
• Subjects with inflammatory, infectious and neuroinflammatory underlying disease which could cause an expected impairment of the blood brain barrier such as meningitis, multiple sclerosis, epilepsy, or Alzheimer's.
• Any household contact who is immunodeficient, HIV positive or pregnant
• Working with livestock
• Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, exclud-ing a single febrile seizure as a child
• Known history of Guillain-Barré Syndrome
• 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
• 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 60 days of enrollment or plans to donate within the study period
• Receipt of chronic immune suppressants or other immune-modifying drugs within 6 months of study inclusion
• Subjects with skin lesions close to the injection site or active oral lesions will be excluded.
• Thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
• Subjects with a significant infection or known inflammation.
• History of relevant cardiovascular disorders or evidence of hyper- or hypotension
• Subjects who are known or suspected not to comply with the study directives.
• Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study