Status:
COMPLETED
VSV-ZEBOV Geneva Vaccine Trial
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
World Health Organization
Wellcome Trust
Conditions:
Ebolavirus Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevent...
Detailed Description
This single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study will have two randomization schemes. Volunteers who could later be exposed to Ebolavirus while working in epi...
Eligibility Criteria
Inclusion
- Has provided written informed consent before screening
- Adult male or non-pregnant, non-lactating female, ages 18 to 65 (inclusive) at the time of screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
- Females of childbearing potential who are willing to use an effective method of contraception, from at least 7 days prior to vaccination through the end of the study period, and a double method from day 0 through day 28
- Males who are willing to use effective contraception from day 0 through day 28:
- Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
- Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse (avoiding the sharing of needles, razors, or toothbrushes, avoiding open-mouth kissing, be willing to refrain from blood donation during the course of the study)
Exclusion
- Prior receipt of an Ebolavirus or Marburgvirus vaccine, a VSV-vectored vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data
- Serologic evidence of prior Ebola exposure
- Has a household contact (HHC) who is immunodeficient, HIV-positive, pregnant, has an unstable medical condition in the opinion of the investigator (e.g., New York Heart Association Class ≥ II heart failure, severe debilitating asthma and/or chronic obstructive pulmonary disease)
- Works with livestock
- 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
- Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial
- Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial
- 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
- Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose
- Serologic evidence of hepatitis C infection, evidence of active hepatitis B infection
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the previous 5 years, and/or diabetes
- Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding febrile seizures as a child
- Has a known history of Guillain-Barré Syndrome
- Has an active malignancy or recent (\< 10 years) history of metastatic or hematologic malignancy
- Suspected or known alcohol and/or illicit drug abuse within the past 5 years
- Pregnant or lactating female, or female who intends to become pregnant during the study period
- 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 (\> 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry
- Any other significant finding that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT02287480
Start Date
November 1 2014
End Date
January 1 2016
Last Update
May 10 2023
Active Locations (1)
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1
University Hospitals of Geneva
Geneva, Switzerland, 1211