Status:
COMPLETED
A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Infectious Disease Service, CHUV, Lausanne
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Conditions:
Ebola Vaccines
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this trial is to assess in healthy adults the safety and reactogenicity of a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the glycoprotein of Zair...
Eligibility Criteria
Inclusion
- Healthy adults aged 18 to 65 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 their general practitioner
- 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
- For females of reproductive capacity, having a negative pregnancy test on the day(s) of screening and vaccination if \>7 days interval
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Exclusion
- 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 or a chimpanzee adenovirus vectored vaccine
- 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 (influenza vaccination is encouraged prior to participation)
- Receipt of any investigational vaccine within 3 months prior to enrollment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- 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)
- History of allergic reactions likely to be exacerbated by any component of the vaccine,
- 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 intramuscular injections or venepuncture
- Any other serious chronic illness requiring hospital specialist supervision
- Current anti-tuberculosis prophylaxis or therapy
- Suspected or known current alcohol abuse
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02289027
Start Date
October 1 2014
End Date
June 1 2015
Last Update
January 28 2016
Active Locations (1)
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1
Clinical Trial Unit Lausanne
Lausanne, Switzerland, 1011