- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289027
A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland
A Phase I/II Double-blind, Randomized, Placebo Controlled, Safety and Immunogenicity, Dose-finding Trial of the Monovalent Zaire Ebola Chimpanzee Adenovirus Vector Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Lausanne, Switzerland, 1011
- Clinical Trial Unit Lausanne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deployed volunteers - Group 1
Low dose cAd3-EBOZ (2.5x10e10 vp)
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Experimental: Deployed volunteers - Group 2
High dose cAd3-EBOZ (5x10e10 vp)
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Experimental: Not deployed volunteers - Group 3
Low dose cAd3-EBOZ (2.5x10e10 vp)
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Experimental: Not deployed volunteers - Group 4
High dose cAd3-EBOZ (5x10e10 vp)
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Placebo Comparator: Not deployed volunteers - Group 5
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Diluent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Solicited local and systemic reactogenicity signs and symptoms
Time Frame: Daily for 7 days following the vaccination
|
Solicited local signs and symptoms include: pain at injection site; erythema at injection site; swelling at injection site. They will be assessed according to a preestablished scale (grade 1 to 3). Solicited systemic signs and symptoms include: fever; tachycardia; bradycardia; systolic hypertension; distolic hypertension; systolic hypotension. They will be assessed according to a preestablished scale (grade 1 to 3). |
Daily for 7 days following the vaccination
|
Unsolicited adverse events of all severities
Time Frame: Through 28 days after the vaccination
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Unsolicited adverse events will be assessed according to a severity grading scale (grade 1 to 3).
|
Through 28 days after the vaccination
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Change from baseline for safety laboratory measures
Time Frame: Through 6 months after the vaccination
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Safety laboratory measures include: hemoglobin; white blood cells count; neutrophil count; lymphocyte count; platelets; total bilirubin; alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase; creatinine; urea; sodium; potassium; partial thromboplastin time (aPTT).
They will be assessed according to a severity grading scale (grade 1 to 3).
|
Through 6 months after the vaccination
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Occurrence of serious adverse events and suspected unexpected serious adverse reactions
Time Frame: Through 6 months after the vaccination
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SAE are defined as AE that result in any of the following outcomes, whether or not considered related to the study intervention:
A SUSAR is a suspected unexpected serious adverse reaction thought to be possibly, probably or definitely related to an IMP. No category of SAE has been defined as 'expected'. |
Through 6 months after the vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antibody responses as measured by ELISA (anti-EBOZ immunoglobulins titers) and by antigen-specific neutralization assays
Time Frame: Through 6 months after the vaccination
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Through 6 months after the vaccination
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T cell immune responses as measured by ex-vivo ELISPOT
Time Frame: Through 6 months after the vaccination
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Through 6 months after the vaccination
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
T cell immune responses as measured by intracellular cytokine staining assays (ICS)
Time Frame: Through 6 months after the vaccination
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Through 6 months after the vaccination
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T cell immune responses as measured by 6-day culture cytokine production by Multiplex and flow cytometry
Time Frame: Through 6 months after the vaccination
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Through 6 months after the vaccination
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HLA typing
Time Frame: On Day 0 (day of vaccination)
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On Day 0 (day of vaccination)
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Vaccine-induced mRNA expression profiles (transcriptomics)
Time Frame: Through 28 days after the vaccination
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Through 28 days after the vaccination
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Blaise Genton, MD PhD, CHUV and PMU
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- cAd3-EBOZ Lau
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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