Phase 1 Trial of Ebola Vaccine in Mali
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.
1 other identifier
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2016
CompletedSeptember 26, 2019
September 1, 2019
1.6 years
October 3, 2014
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Daily for 7 days following each vaccination.
Occurrence of unsolicited adverse events
28 days following the vaccination
Change from baseline for safety laboratory measures
6 months for each volunteer
Occurrence of serious adverse events and incident chronic medical conditions
6 months for each volunteer
Secondary Outcomes (2)
Antibody responses as measured by ELISA and neutralization assays
Day 1, 7, 14, 28, 90 and 180 after vaccination
T cell immune responses as measured by intracellular cytokine staining assay
Day 1, 7 and 14 after vaccination
Study Arms (5)
2.5 x 10(10) vp
EXPERIMENTALEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 2.5 x 10(10):
5 x 10(10) vp
EXPERIMENTALEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 5 x 10(10):
1.0 x 10(10) vp
EXPERIMENTALEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(10):
1.0 x 10(11) vp
EXPERIMENTALEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(11):
Booster-MVA-BN® Filo or saline placebo
EXPERIMENTALMVA-BN® Filo or saline placebo
Interventions
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
IM injection of Booster-MVA-BN® Filo or saline placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- Wellcome Trustcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Leidos Biomedical Research, Inc.collaborator
Study Sites (1)
Center for Vaccine Development, Mali
Bamako, Mali
Related Publications (1)
Tapia MD, Sow SO, Lyke KE, Haidara FC, Diallo F, Doumbia M, Traore A, Coulibaly F, Kodio M, Onwuchekwa U, Sztein MB, Wahid R, Campbell JD, Kieny MP, Moorthy V, Imoukhuede EB, Rampling T, Roman F, De Ryck I, Bellamy AR, Dally L, Mbaya OT, Ploquin A, Zhou Y, Stanley DA, Bailer R, Koup RA, Roederer M, Ledgerwood J, Hill AVS, Ballou WR, Sullivan N, Graham B, Levine MM. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2016 Jan;16(1):31-42. doi: 10.1016/S1473-3099(15)00362-X. Epub 2015 Nov 4.
PMID: 26546548DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Myron M Levine, MD, DTPH
University of Maryland, Baltimore
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Pediatrics & Infectious Tropical Diseases
Study Record Dates
First Submitted
October 3, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
April 20, 2016
Study Completion
April 20, 2016
Last Updated
September 26, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share