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A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289027
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
Infectious Disease Service, CHUV, Lausanne
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
University of Lausanne Hospitals
Swiss Tropical & Public Health Institute
University of Lausanne
GlaxoSmithKline
World Health Organization
Immunology and Allergy Service, CHUV, Lausanne
Information provided by (Responsible Party):
François Spertini, Centre Hospitalier Universitaire Vaudois

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 Zaire Ebola virus. The secondary objectives will be to assess the immunogenicity of the candidate vaccine and find the most suitable dose for further deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of possibly exposed volunteers owning to organisations such as "Médecins sans frontières" and susceptible to be deployed in the outbreak zone (named as "possibly exposed volunteers"). The other volunteers will be adults with no planned travels to the epidemic zone (named as "not exposed volunteers"). The first group will be randomly allocated to two different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp). The second group will be randomly allocated to three different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.

Condition or disease Intervention/treatment Phase
Ebola Vaccines Biological: cAd3-EBOZ vaccine Biological: Placebo (for cAd3-EBOZ vaccine) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Deployed volunteers - Group 1
Low dose cAd3-EBOZ (2.5x10e10 vp)
Biological: cAd3-EBOZ vaccine
Experimental: Deployed volunteers - Group 2
High dose cAd3-EBOZ (5x10e10 vp)
Biological: cAd3-EBOZ vaccine
Experimental: Not deployed volunteers - Group 3
Low dose cAd3-EBOZ (2.5x10e10 vp)
Biological: cAd3-EBOZ vaccine
Experimental: Not deployed volunteers - Group 4
High dose cAd3-EBOZ (5x10e10 vp)
Biological: cAd3-EBOZ vaccine
Placebo Comparator: Not deployed volunteers - Group 5 Biological: Placebo (for cAd3-EBOZ vaccine)
Diluent




Primary Outcome Measures :
  1. 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).


  2. Unsolicited adverse events of all severities [ Time Frame: Through 28 days after the vaccination ]
    Unsolicited adverse events will be assessed according to a severity grading scale (grade 1 to 3).

  3. Change from baseline for safety laboratory measures [ Time Frame: Through 6 months after the vaccination ]
    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).

  4. Occurrence of serious adverse events and suspected unexpected serious adverse reactions [ Time Frame: Through 6 months after the vaccination ]

    SAE are defined as AE that result in any of the following outcomes, whether or not considered related to the study intervention:

    • Death
    • Life-threatening event
    • Persistent or significant disability or incapacity
    • Hospitalisation
    • An important medical event (that may not cause death, be life threatening, or require hospitalisation) that may, based upon appropriate medical judgment, jeopardise the volunteer and/or require medical or surgical intervention to prevent one of the outcomes listed above.
    • Congenital anomaly or birth defect.

    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'.



Secondary Outcome Measures :
  1. Antibody responses as measured by ELISA (anti-EBOZ immunoglobulins titers) and by antigen-specific neutralization assays [ Time Frame: Through 6 months after the vaccination ]
  2. T cell immune responses as measured by ex-vivo ELISPOT [ Time Frame: Through 6 months after the vaccination ]

Other Outcome Measures:
  1. T cell immune responses as measured by intracellular cytokine staining assays (ICS) [ Time Frame: Through 6 months after the vaccination ]
  2. 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 ]
  3. HLA typing [ Time Frame: On Day 0 (day of vaccination) ]
  4. Vaccine-induced mRNA expression profiles (transcriptomics) [ Time Frame: Through 28 days after the vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults aged 18 to 65 years
  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:

  1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289027


Locations
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Switzerland
Clinical Trial Unit Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Infectious Disease Service, CHUV, Lausanne
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
University of Lausanne Hospitals
Swiss Tropical & Public Health Institute
University of Lausanne
GlaxoSmithKline
World Health Organization
Immunology and Allergy Service, CHUV, Lausanne
Investigators
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Principal Investigator: Blaise Genton, MD PhD CHUV and PMU
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: François Spertini, Head physician Immunology and Allergy, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02289027    
Other Study ID Numbers: cAd3-EBOZ Lau
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by François Spertini, Centre Hospitalier Universitaire Vaudois:
Ebola, Ebolavirus
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs