Ebola Virus DiseasePhase 1NCT02495246
A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
A Phase 1 study testing ChAd3-EBO-Z and Ad26.ZEBOV in people with Ebola Virus Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- ChAd3-EBO-Z and Ad26.ZEBOV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2015to 22 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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
- 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 and Appendix 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
- Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Ebola Virus Disease
- Being tested
- ChAd3-EBO-Z, Ad26.ZEBOV
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd3-EBO-ZBiological
Ad26.ZEBOVBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | ChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 28 days later. Receives: Biological: ChAd3-EBO-Z; Biological: Ad26.ZEBOV |
| Group 2 | Active comparator | Ad26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 28 days later. Receives: Biological: ChAd3-EBO-Z; Biological: Ad26.ZEBOV |
| Group 3 | Active comparator | ChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 56 days later. Receives: Biological: ChAd3-EBO-Z; Biological: Ad26.ZEBOV |
| Group 4 | Active comparator | Ad26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 56 days later. Receives: Biological: ChAd3-EBO-Z; Biological: Ad26.ZEBOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start21 Sep 2015
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495246
- Sponsor's protocol ID
- EBL05
- Status last verified
- Apr 2018
- First submitted
- 18 Jun 2015
- Last updated
- 11 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02495246
- Acronym / sponsor ID
- EBL05
- Conditions
- Ebola Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 21 Sep 2015 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: ChAd3-EBO-Z, Biological: Ad26.ZEBOVChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 28 days later. |
| Group 2 | Active comparator | Biological: ChAd3-EBO-Z, Biological: Ad26.ZEBOVAd26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 28 days later. |
| Group 3 | Active comparator | Biological: ChAd3-EBO-Z, Biological: Ad26.ZEBOVChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 56 days later. |
| Group 4 | Active comparator | Biological: ChAd3-EBO-Z, Biological: Ad26.ZEBOVAd26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 56 days later. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAd3-EBO-Z | Biological | Group 1, Group 2, Group 3, Group 4 |
| Ad26.ZEBOV | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAd3-EBO-Z and Ad26.ZEBOV in people with Ebola Virus Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 17 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.