Phase 1 Trial of Ebola Vaccine in Mali

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02267109
• Date of registration: 03/10/2014
• Prospective Registration: No
• Primary sponsor: University of Maryland, Baltimore
• Public title: Phase 1 Trial of Ebola Vaccine in Mali
• Scientific 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.
• Date of first enrolment: October 2014
• Target sample size: 91
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02267109
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Mali

Contacts

• Name: Myron M Levine, MD, DTPH
• Affiliation: University of Maryland, Baltimore

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Hemorrhagic Fever

Intervention(s)

Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z

Biological: Booster-MVA-BN® Filo or saline placebo

Primary Outcome(s)

Occurrence of solicited local and systemic reactogenicity signs and symptoms [Time Frame: Daily for 7 days following each vaccination.]

Occurrence of unsolicited adverse events [Time Frame: 28 days following the vaccination]

Occurrence of serious adverse events and incident chronic medical conditions [Time Frame: 6 months for each volunteer]

Change from baseline for safety laboratory measures [Time Frame: 6 months for each volunteer]

Secondary Outcome(s)

Antibody responses as measured by ELISA and neutralization assays [Time Frame: Day 1, 7, 14, 28, 90 and 180 after vaccination]

T cell immune responses as measured by intracellular cytokine staining assay [Time Frame: Day 1, 7 and 14 after vaccination]

Secondary ID(s)

HP-00061513

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

Leidos Biomedical Research, Inc.

Wellcome Trust