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Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination

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: NCT02485912
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.

All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8 pfu.

All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later.

The site of administration of the MVA-EBO Z vaccine differs between the two groups:

Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.

Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.

The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.

The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.

Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.


Condition or disease Intervention/treatment Phase
Ebola Virus Disease Biological: ChAd3-EBO Z Biological: MVA-EBO Z Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Active Comparator: Group 1
ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm.
Biological: ChAd3-EBO Z
This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein

Biological: MVA-EBO Z
This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein

Active Comparator: Group 2
ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.
Biological: ChAd3-EBO Z
This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein

Biological: MVA-EBO Z
This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein




Primary Outcome Measures :
  1. Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events. [ Time Frame: 26 weeks ]

    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

    The following parameters will be assessed for both groups:

    • Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination
    • Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination
    • Occurrence of unsolicited adverse events for 28 days following the vaccination
    • Change from baseline for safety laboratory measures
    • Occurrence of serious adverse events during the whole study duration


Secondary Outcome Measures :
  1. To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years [ Time Frame: 26 weeks ]

    Ebolavirus specific immunogenicity will be assessed by a variety of immunological assays. The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.

    Exploratory outcome measures will include ex-vivo ELISPOT, plasma blast assays and flow cytometry performed with research samples collected at different study timepoints as well as other immunogenicity assays throughout the study. An evaluation of genetic factors associated with immune responses may be performed as exploratory evaluation. Vaccine-induced mRNA expression profiles during 1 week after vaccination may also be performed as an exploratory evaluation.




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 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18 to 50 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative 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

Exclusion Criteria:

  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned participation during the study period
  • Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, an MVA 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, (e.g. egg products) 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 current or previous psychiatric illness.
  • 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 venepuncture
  • Any other serious chronic illness
  • Current anti-tuberculosis prophylaxis or therapy
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • History of contact with suspected, probable or confirmed cases of Ebola in the previous 21 days
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A & B)
  • 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): NCT02485912


Locations
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Senegal
Centre Hospitalier Universitaire le Dantec
Dakar, Senegal, BP 7325
Sponsors and Collaborators
University of Oxford
Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
Investigators
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Principal Investigator: Souleymane Mboup, MD; PhD Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02485912    
Other Study ID Numbers: EBL06
First Posted: June 30, 2015    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019
Last Verified: February 2016
Keywords provided by University of Oxford:
Ebola
vaccine
safety
immunogenicity
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections