A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland
NCT ID: NCT02289027
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2014-10-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Deployed volunteers - Group 1
Low dose cAd3-EBOZ (2.5x10e10 vp)
cAd3-EBOZ vaccine
Deployed volunteers - Group 2
High dose cAd3-EBOZ (5x10e10 vp)
cAd3-EBOZ vaccine
Not deployed volunteers - Group 3
Low dose cAd3-EBOZ (2.5x10e10 vp)
cAd3-EBOZ vaccine
Not deployed volunteers - Group 4
High dose cAd3-EBOZ (5x10e10 vp)
cAd3-EBOZ vaccine
Not deployed volunteers - Group 5
Placebo (for cAd3-EBOZ vaccine)
Diluent
Interventions
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cAd3-EBOZ vaccine
Placebo (for cAd3-EBOZ vaccine)
Diluent
Eligibility Criteria
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Inclusion Criteria
2. Able and willing (in the Investigator's opinion) to comply with all study requirements
3. Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner
4. For females of reproductive capacity and males, having practiced continuous effective contraception for 21 days prior to enrolment, and willing to practice continuous effective contraception for 3 months post vaccination
5. For females of reproductive capacity, having a negative pregnancy test on the day(s) of screening and vaccination if \>7 days interval
6. Agreement to refrain from blood donation during the course of the study
7. Provide written informed consent
Exclusion Criteria
2. Prior receipt of an investigational Ebola or Marburg vaccine or a chimpanzee adenovirus vectored vaccine
3. Receipt of any live, attenuated vaccine within 28 days prior to enrolment
4. Receipt of any subunit or killed vaccine within 14 days prior to enrolment (influenza vaccination is encouraged prior to participation)
5. Receipt of any investigational vaccine within 3 months prior to enrollment
6. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
7. Any confirmed or suspected immunosuppressed or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive medication within the past 6 months (inhaled and topical steroids are allowed)
8. History of allergic reactions likely to be exacerbated by any component of the vaccine,
9. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
10. Any history of anaphylaxis in reaction to vaccination
11. Pregnancy, lactation or willingness/intention to become pregnant during the study
12. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
13. History of serious psychiatric condition
14. Poorly controlled asthma or thyroid disease
15. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
16. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
17. Any other serious chronic illness requiring hospital specialist supervision
18. Current anti-tuberculosis prophylaxis or therapy
19. Suspected or known current alcohol abuse
20. Suspected or known injecting drug abuse in the 5 years preceding enrolment
21. Seropositive for hepatitis B surface antigen (HBsAg)
22. Seropositive for hepatitis C virus (antibodies to HCV)
23. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
24. 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
18 Years
65 Years
ALL
Yes
Sponsors
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Infectious Disease Service, CHUV, Lausanne
UNKNOWN
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
OTHER
University of Lausanne Hospitals
OTHER
Swiss Tropical & Public Health Institute
OTHER
University of Lausanne
OTHER
GlaxoSmithKline
INDUSTRY
World Health Organization
OTHER
Immunology and Allergy Service, CHUV, Lausanne
UNKNOWN
Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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François Spertini
Head physician Immunology and Allergy
Principal Investigators
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Blaise Genton, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHUV and PMU
Locations
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Clinical Trial Unit Lausanne
Lausanne, , Switzerland
Countries
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References
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De Santis O, Audran R, Pothin E, Warpelin-Decrausaz L, Vallotton L, Wuerzner G, Cochet C, Estoppey D, Steiner-Monard V, Lonchampt S, Thierry AC, Mayor C, Bailer RT, Mbaya OT, Zhou Y, Ploquin A, Sullivan NJ, Graham BS, Roman F, De Ryck I, Ballou WR, Kieny MP, Moorthy V, Spertini F, Genton B. Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study. Lancet Infect Dis. 2016 Mar;16(3):311-20. doi: 10.1016/S1473-3099(15)00486-7. Epub 2015 Dec 23.
Other Identifiers
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cAd3-EBOZ Lau
Identifier Type: -
Identifier Source: org_study_id
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