Status:
UNKNOWN
A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
World Health Organization
Wellcome Trust
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a...
Detailed Description
This study is being conducted to assess safety and immunogenicity of an experimental ebola vaccine. An outbreak due to the Ebola Zaire (ZEBOV) strain of unprecedented magnitude and scope and with a h...
Eligibility Criteria
Inclusion
- • Have provided written informed consent prior to screening procedures (i.e. participants must be literate).
- Healthy adult male or non-pregnant, non-lactating female, ages 18 to 55 (inclusive) at the time of screening
- Free of clinically significant health problems, as determined by pertinent medical history, clinical examination and blood tests at screening
- Available, able, and willing to participate for all study visits and procedures
- Negative pregnancy-test for female volunteers
- Females, of non-childbearing potential who are post-menopausal (i.e. ≥ one year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
- Females, of childbearing potential, who are willing to use effective methods of contraception for 14 days before vaccination and 30 days after vaccination.
- Males who are willing to use effective contraception following vaccination for a period of one week.
- Be willing to minimize blood and body fluid exposure of others for 5 days after vaccination
Exclusion
- • 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
- Unable or unwilling to stay in the study area for the period of the study and comply with study procedures.
- 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
- Any serologic evidence of hepatitis B SAg or HIV infection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes
- 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 2 weeks prior to vaccination
- Pregnant or lactating woman or a woman who intends to become pregnant within 30 days following vaccination.
- Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
- Administration of chronic (defined as more than 14 days) immunosuppressant's 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 having an adverse outcome from participating in this study
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02296983
Start Date
December 1 2014
End Date
September 1 2016
Last Update
April 14 2016
Active Locations (1)
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1
KEMRI Wellcome Trust Research Programme
Kilifi, Coast, Kenya, 80108