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A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

Primary Purpose

Ebola Virus Disease

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MVA-EBO Z
ChAd3-EBO Z
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Virus Disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 18 to 50 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 GP
    • For females only, willingness to practice continuous effective contraception (see section 6.3.3) 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 use during the study period
  • Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus, or MVA vectored 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; functional hyposplenism, 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, including urticaria, respiratory difficulty or abdominal pain
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of an anaphylactic reaction
  • 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
  • History of coeliac disease
  • 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 requiring hospital specialist supervision
  • 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)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Travel to a Ebola or Marburg endemic region during the study period or within the previous six months
  • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A)
  • 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
  • Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

Sites / Locations

  • Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1a

Group 1b

Group 2

Group 3

Group 4

Arm Description

MVA-EBO Z (1 x 10^8 pfu)

MVA-EBO Z (1.5 x 10^8 pfu)

ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 14 days

ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 28 days

ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1.5 x 10^8 pfu) after 28 days

Outcomes

Primary Outcome Measures

Safety and tolerability of the first-in-human administration of MVA-EBO Z alone. This will be done by recording the number of participants who experience adverse events.
Safety and tolerability of the first-in-human administration of MVA-EBO Z . This will be done by recording the severity of adverse events
Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the number of participants who experience adverse events.
Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the severity of adverse events

Secondary Outcome Measures

Full Information

First Posted
May 7, 2015
Last Updated
August 22, 2016
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT02451891
Brief Title
A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z
Official Title
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of MVA-EBO Z Alone and a Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy UK Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

5. Study Description

Brief Summary
This is a clinical trial in which healthy volunteers will be administered experimental Ebola vaccines. The investigators will vaccinate four groups of volunteers. Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu. Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4). 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 cAd3-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 Oxford and London England. The study will be funded by the Wellcome Trust.
Detailed Description
It is important to answer this question to understand how best to deploy the vaccine in an outbreak setting, and to give an indication as to whether booster vaccinations may need to be considered to maintain immunity. In light of this, the extension study has invited volunteers to attend some further optional follow up visits. It would involve obtaining some further blood tests to look for the same markers of vaccine induced immune response that were looked for in the first part of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1a
Arm Type
Active Comparator
Arm Description
MVA-EBO Z (1 x 10^8 pfu)
Arm Title
Group 1b
Arm Type
Active Comparator
Arm Description
MVA-EBO Z (1.5 x 10^8 pfu)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 14 days
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 28 days
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1.5 x 10^8 pfu) after 28 days
Intervention Type
Biological
Intervention Name(s)
MVA-EBO Z
Intervention Type
Biological
Intervention Name(s)
ChAd3-EBO Z
Primary Outcome Measure Information:
Title
Safety and tolerability of the first-in-human administration of MVA-EBO Z alone. This will be done by recording the number of participants who experience adverse events.
Time Frame
24 weeks
Title
Safety and tolerability of the first-in-human administration of MVA-EBO Z . This will be done by recording the severity of adverse events
Time Frame
24 weeks
Title
Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the number of participants who experience adverse events.
Time Frame
28 weeks
Title
Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the severity of adverse events
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 18 to 50 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 GP For females only, willingness to practice continuous effective contraception (see section 6.3.3) 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 use during the study period Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus, or MVA vectored 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; functional hyposplenism, 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, including urticaria, respiratory difficulty or abdominal pain Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. Any history of an anaphylactic reaction 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 History of coeliac disease 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 requiring hospital specialist supervision 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) Seropositive for hepatitis C virus (antibodies to HCV) Travel to a Ebola or Marburg endemic region during the study period or within the previous six months Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A) 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 Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Facility Information:
Facility Name
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30407513
Citation
Venkatraman N, Ndiaye BP, Bowyer G, Wade D, Sridhar S, Wright D, Powlson J, Ndiaye I, Dieye S, Thompson C, Bakhoum M, Morter R, Capone S, Del Sorbo M, Jamieson S, Rampling T, Datoo M, Roberts R, Poulton I, Griffiths O, Ballou WR, Roman F, Lewis DJM, Lawrie A, Imoukhuede E, Gilbert SC, Dieye TN, Ewer KJ, Mboup S, Hill AVS. Safety and Immunogenicity of a Heterologous Prime-Boost Ebola Virus Vaccine Regimen in Healthy Adults in the United Kingdom and Senegal. J Infect Dis. 2019 Apr 8;219(8):1187-1197. doi: 10.1093/infdis/jiy639.
Results Reference
derived

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A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

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