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Phase 1 Trial of Ebola Vaccine in Mali

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02267109
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Leidos Biomedical Research, Inc.
Information provided by (Responsible Party):
Milagritos Tapia, University of Maryland, Baltimore

Brief Summary:
Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Hemorrhagic Fever Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z Biological: Booster-MVA-BN® Filo or saline placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1b, Dose-escalating Safety and Immunogenicity Trial of the Novel Monovalent Ebola Zaire Candidate Vaccine, cAd3-EBO Z and the Heterologous Prime-boost Candidate Vaccine Regimen of cAD3-EBO Z Followed by MVA-BN® Filo in Malian Adults Aged 18-50 Years.
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 20, 2016
Actual Study Completion Date : April 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: 2.5 x 10(10) vp
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 2.5 x 10(10):
Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Other Name: cAd3-EBO Z:

Biological: Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo

Experimental: 5 x 10(10) vp
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 5 x 10(10):
Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Other Name: cAd3-EBO Z:

Biological: Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo

Experimental: 1.0 x 10(10) vp
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(10):
Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Other Name: cAd3-EBO Z:

Biological: Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo

Experimental: 1.0 x 10(11) vp
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(11):
Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Other Name: cAd3-EBO Z:

Biological: Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo

Experimental: Booster-MVA-BN® Filo or saline placebo
MVA-BN® Filo or saline placebo
Biological: Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo




Primary Outcome Measures :
  1. Occurrence of solicited local and systemic reactogenicity signs and symptoms [ Time Frame: Daily for 7 days following each vaccination. ]
  2. Occurrence of unsolicited adverse events [ Time Frame: 28 days following the vaccination ]
  3. Change from baseline for safety laboratory measures [ Time Frame: 6 months for each volunteer ]
  4. Occurrence of serious adverse events and incident chronic medical conditions [ Time Frame: 6 months for each volunteer ]

Secondary Outcome Measures :
  1. Antibody responses as measured by ELISA and neutralization assays [ Time Frame: Day 1, 7, 14, 28, 90 and 180 after vaccination ]
  2. T cell immune responses as measured by intracellular cytokine staining assay [ Time Frame: Day 1, 7 and 14 after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adults aged 18 to 50 years

  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with his/her health care provider
  • For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Provide written informed consent

Exclusion Criteria:

  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, MVA vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
  • Receipt of any live, attenuated vaccine within 28 days prior to enrolment
  • Receipt of any subunit or killed vaccine within 14 days prior to enrolment
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of anaphylaxis in reaction to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Poorly controlled asthma or thyroid disease
  • Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
  • Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
  • Any known history of cardiac disease
  • Any other serious chronic illness requiring hospital specialist supervision
  • Current anti-tuberculosis prophylaxis or therapy
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Travel to an Ebola or Marburg endemic region during the study period or within the previous six months or history of recovery from Ebola or Marburg virus disease.
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
  • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267109


Locations
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Mali
Center for Vaccine Development, Mali
Bamako, Mali
Sponsors and Collaborators
University of Maryland, Baltimore
Wellcome Trust
National Institute of Allergy and Infectious Diseases (NIAID)
Leidos Biomedical Research, Inc.
Investigators
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Study Director: Myron M Levine, MD, DTPH University of Maryland, Baltimore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Milagritos Tapia, Assistant Professor, Pediatrics & Infectious Tropical Diseases, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02267109    
Other Study ID Numbers: HP-00061513
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections