A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
A Phase I, Safety and Immunogenicity Trial of the Heterologous Prime-boost Regimen Combining the Monovalent Zaire Ebola Viral Vector Candidates ChAd3-EBO-Z and Ad26.ZEBOV in Healthy UK Adults
1 other identifier
interventional
32
1 country
1
Brief Summary
This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen. All ChAd3-EBO-Z doses are 1x10\^11 vp and all Ad26.ZEBOV doses are 5x10\^10 vp. Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days later. Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days later. Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days later. Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days later. 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 Ad26.ZEBOV 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 co-funded by GSK Biologicals and Crucell Holland BV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedStudy Start
First participant enrolled
September 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2017
CompletedApril 11, 2018
April 1, 2018
1.9 years
June 18, 2015
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Safety and tolerability of administration of ChAd3-EBO-Z and Ad26.ZEBOV 28 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events.
17 weeks
Safety and tolerability of administration of Ad26.ZEBOV and ChAd3-EBO-Z 28 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events.
17 weeks
Safety and tolerability of administration of ChAd3-EBO-Z and Ad26.ZEBOV 56 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events.
21 weeks
Safety and tolerability of administration of Ad26.ZEBOV and ChAd3-EBO-Z 56 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events.
21 weeks
Study Arms (4)
Group 1
ACTIVE COMPARATORChAd3-EBO-Z (1x10\^11 vp) and Ad26.ZEBOV (5x10\^10 vp) 28 days later.
Group 2
ACTIVE COMPARATORAd26.ZEBOV (5x10\^10 vp) and ChAd3-EBO-Z (1x10\^11 vp) 28 days later.
Group 3
ACTIVE COMPARATORChAd3-EBO-Z (1x10\^11 vp) and Ad26.ZEBOV (5x10\^10 vp) 56 days later.
Group 4
ACTIVE COMPARATORAd26.ZEBOV (5x10\^10 vp) and ChAd3-EBO-Z (1x10\^11 vp) 56 days later.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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 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 IM injections or venepuncture
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Oxfordshire, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
July 13, 2015
Study Start
September 21, 2015
Primary Completion
August 22, 2017
Study Completion
August 22, 2017
Last Updated
April 11, 2018
Record last verified: 2018-04