Ebola Virus DiseasePhase 1NCT02451891
A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z
A Phase 1 study testing MVA-EBO Z and ChAd3-EBO Z 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 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. 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?
- MVA-EBO Z and ChAd3-EBO Z
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 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 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)
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Ebola Virus Disease
- Being tested
- MVA-EBO Z, ChAd3-EBO Z
- 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.
MVA-EBO ZBiological
ChAd3-EBO ZBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1a | Active comparator | MVA-EBO Z (1 x 10^8 pfu) Receives: Biological: MVA-EBO Z |
| Group 1b | Active comparator | MVA-EBO Z (1.5 x 10^8 pfu) Receives: Biological: MVA-EBO Z |
| Group 2 | Active comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 14 days Receives: Biological: MVA-EBO Z; Biological: ChAd3-EBO Z |
| Group 3 | Active comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 28 days Receives: Biological: MVA-EBO Z; Biological: ChAd3-EBO Z |
| Group 4 | Active comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1.5 x 10^8 pfu) after 28 days Receives: Biological: MVA-EBO Z; Biological: ChAd3-EBO Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Safety and tolerability of the first-in-human administration of MVA-EBO Z . This will be done by recording the severity of adverse events
Measured: 24 weeks
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.
Measured: 28 weeks
Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the severity of adverse events
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start6 May 2015
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Why it stopped: Long term follow up will take place in a new clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT02451891
- Sponsor's protocol ID
- EBL04
- Status last verified
- Aug 2016
- First submitted
- 7 May 2015
- Last updated
- 18 Dec 2025
- Results posted
- No
Publications
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.
PubMed 30407513
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02451891
- Acronym / sponsor ID
- EBL04
- Conditions
- Ebola Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Long term follow up will take place in a new clinical trial.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 22 May 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1a | Active comparator | Biological: MVA-EBO ZMVA-EBO Z (1 x 10^8 pfu) |
| Group 1b | Active comparator | Biological: MVA-EBO ZMVA-EBO Z (1.5 x 10^8 pfu) |
| Group 2 | Active comparator | Biological: MVA-EBO Z, Biological: ChAd3-EBO ZChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 14 days |
| Group 3 | Active comparator | Biological: MVA-EBO Z, Biological: ChAd3-EBO ZChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 28 days |
| Group 4 | Active comparator | Biological: MVA-EBO Z, Biological: ChAd3-EBO ZChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1.5 x 10^8 pfu) after 28 days |
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
Key exclusion criteria (26 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 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
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 |
|---|---|---|
| MVA-EBO Z | Biological | Group 1a, Group 1b, Group 2, Group 3, Group 4 |
| ChAd3-EBO Z | Biological | Group 2, Group 3, Group 4 |
Primary outcome
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
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
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
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
Results and safety
The study was stopped early (reason given: Long term follow up will take place in a new clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 30407513Venkatraman 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.
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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 MVA-EBO Z and ChAd3-EBO Z 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 26 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: stopped early, as of the sponsor's last update on 18 Dec 2025. 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 was stopped early (reason given: Long term follow up will take place in a new clinical trial.). Results are not available in the source record.
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 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). 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?
On the ClinicalTrials.gov record for NCT02451891, which also lists 1 linked publication.
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 18 Dec 2025.