A Phase I/II Dose-finding Randomized, Single-center, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Vesicular Stomatitis Virus-vectored Zaire Ebola Candidate Vaccine BPSC1001 (VSVΔG-ZEBOV) in Healthy Adults.

CCER 14-221

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 prevention available at this time. The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials are needed. To accelerate this process, the World Health Organization (WHO) has constituted a consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use similar protocols to collectively include roughly 250 volunteers, the sample size required to identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2 different doses of BPSC1001. The joint primary objectives of this single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine dose and to define whether seroresponses differ significantly following immunization with the lower or higher vaccine dose.

2014-11-01

2015-04-01

2016-01-01

Completed

Early phase I

115

Inclusion Criteria: * 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 Criteria: * 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

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2023-05-10