EbolaPhase 1NCT05079750

A Study of a New Vaccine Against Two Types of Ebola

A Phase 1 study testing ChAdOx1 biEBOV in people with Ebola, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Ebola
What is being tested?: ChAdOx1 biEBOV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited Kingdom
Study dates: 11 Nov 2021to 21 Mar 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults aged 18 to 55 years.
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow confirmation of their past medical history either through: provision of a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or by providing an alternative acceptable means of confirming their past medical history.
Agreement to refrain from blood donation during the course of the study.
Provide written informed consent.
For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial.
For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.

Who cannot join

Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
Receipt of a recombinant simian adenoviral vaccine prior to enrolment.
Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV.
Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
Previous receipt of an Ebolavirus vaccine.
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.

Show all 24Show fewer

Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Including hypersensitivity to the active substance or to any of the excipients of the IMP or Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine).
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
History of anaphylaxis in relation to vaccination.
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
History of serious psychiatric condition likely to affect participation in the study.
Ongoing or planned pregnancy or breastfeeding during the trial follow up period.
Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia.
Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine).
Individuals who have previously experienced episodes of capillary leak syndrome.
Any other serious chronic illness requiring hospital specialist supervision.
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.
Detectable circulating hepatitis B surface antigen (HBsAg).
Seropositive for hepatitis C virus (antibodies to HCV).
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Determine the Safety and Immunogenicity of a Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in UK Healthy Adult Volunteers

Read the detailed description

This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy UK volunteers aged 18-55. The vaccine will be administered intramuscularly (IM).

Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a total of 26 volunteers will be enrolled. Dose escalation and sentinel participant procedures will be implemented. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially allocated to a study group by selecting eligible volunteers for enrolment following screening. Sequential allocation will occur based on the order in which volunteers are enrolled.

Conditions: Ebola
Being tested: ChAdOx1 biEBOV
Keywords: Ebola Virus Disease, Zaire Ebolavirus, EBOV, Sudan Ebolavirus, SUDV, Vaccine
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.

ChAdOx1 biEBOVBiological
ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)

Study groups in NCT05079750
Study group	Role	What they receive
Group 1: Low Dose	Experimental	n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10^9 vp Receives: Biological: ChAdOx1 biEBOV
Group 2: Mid Dose	Experimental	n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10^10 vp Receives: Biological: ChAdOx1 biEBOV
Group 3: High Dose	Experimental	n=14 participants vaccinated with either a single dose (n=7) or two doses twelve weeks apart (n=7) of ChAdOx1 biEBOV 5x10^10 vp Receives: Biological: ChAdOx1 biEBOV

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms. Data shown are number (and percentage) of participants reporting each event. The maximum severity of any local and any systemic solicited symptoms reported by individual participants is also shown.
Measured: 7 days following vaccination
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms
Occurrence of unsolicited adverse events (AEs)
Measured: 28 days following vaccination
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events
Occurrence of serious adverse events (SAEs) and adverse interests of special interest (AESIs)
Measured: Duration of the study (6 months)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities
Abnormal results were graded according to a pre-specified laboratory adverse events severity grading scale - a full breakdown of the levels of severity of the reported events per study timepoint is available in the publication.
Measured: 28 days following vaccination

Secondary outcomes (2)

Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity
ELISA to quantify antibodies to filovirus glycoprotein (specific serological response). Peak antibody responses to both Ebola and Sudan viruses occurred 28 days post vaccination (or post-boost, in the participants who received a booster) across all groups.
Measured: At day 28
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity
Intracellular cytokine staining (ICS) by flow cytometry was carried out at baseline as well as at 14 days after vaccination/boost to assess T-cell responses to Ebola virus glycoprotein and Sudan virus glycoprotein.
Measured: 14 days post final vaccine for each group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202121 Mar 2023

First posted15 Oct 2021
Study start11 Nov 2021
Primary completion21 Mar 2023
Study completion21 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EbolaStudies 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: Sequential
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05079750
Sponsor's protocol ID: EBL07
Status last verified: Oct 2021
First submitted: 4 Oct 2021
Last updated: 4 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jenkin D, Makinson R, Sanders H, Sampson A, Platt A, Tran N, Dinesh T, Mabbett R, Lawrie A, Quaddy J, Poulton I, Berrie E, Cicconi P, Lambe T. Safety and immunogenicity of a bivalent Ebola virus and Sudan virus ChAdOx1 vectored vaccine in adults in the UK: an open-label, non-randomised, first-in-human, phase 1 clinical trial. Lancet Microbe. 2025 May;6(5):101022. doi: 10.1016/j.lanmic.2024.101022. Epub 2025 Feb 5.
PubMed 39922207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ebola trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Determine the Safety and Immunogenicity of a Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in UK Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT05079750
Acronym / sponsor ID: EBL07
Conditions: Ebola
Keywords: Ebola Virus Disease, Zaire Ebolavirus, EBOV, Sudan Ebolavirus, SUDV, Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Study start: 11 Nov 2021 (actual)
Primary completion: 21 Mar 2023 (actual)
Study completion: 21 Mar 2023 (actual)
First posted: 15 Oct 2021 (actual)
Results: Posted 4 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: Low Dose	Experimental	Biological: ChAdOx1 biEBOVn=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10^9 vp
Group 2: Mid Dose	Experimental	Biological: ChAdOx1 biEBOVn=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10^10 vp
Group 3: High Dose	Experimental	Biological: ChAdOx1 biEBOVn=14 participants vaccinated with either a single dose (n=7) or two doses twelve weeks apart (n=7) of ChAdOx1 biEBOV 5x10^10 vp

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy adults aged 18 to 55 years.
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow confirmation of their past medical history either through: provision of a GP medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or by providing an alternative acceptable means of confirming their past medical history.
Agreement to refrain from blood donation during the course of the study.
Provide written informed consent.

Key exclusion criteria (24 listed)

Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
Receipt of a recombinant simian adenoviral vaccine prior to enrolment.
Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV.
Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
Previous receipt of an Ebolavirus vaccine.

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
ChAdOx1 biEBOVChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)	Biological	Group 1: Low Dose, Group 2: Mid Dose, Group 3: High Dose

Primary outcome

Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms
Time frame: 7 days following vaccination
Occurrence of solicited local and systemic reactogenicity signs and symptoms. Data shown are number (and percentage) of participants reporting each event. The maximum severity of any local and any systemic solicited symptoms reported by individual participants is also shown.
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms
Time frame: 28 days following vaccination
Occurrence of unsolicited adverse events (AEs)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events
Time frame: Duration of the study (6 months)
Occurrence of serious adverse events (SAEs) and adverse interests of special interest (AESIs)
Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities
Time frame: 28 days following vaccination
Abnormal results were graded according to a pre-specified laboratory adverse events severity grading scale - a full breakdown of the levels of severity of the reported events per study timepoint is available in the publication.

2 secondary outcomes

Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity
Time frame: At day 28
Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity
Time frame: 14 days post final vaccine for each group

Results and safety

Results posted to the registry on 4 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Low Dose	6	6
Group 2: Mid Dose	6	6
Group 3: High Dose	14	13

Primary outcome: Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms

Time frame: 7 days following vaccination. Count of participants. Unit: Participants

Measure	Group 1: Low Dose n = 6	Group 2: Mid Dose n = 6	Group 3: High Dose - Single Dose n = 14	Group 3: High Dose - Two Doses n = 7
Any local symptom: Mild	3	3	9	4
Any local symptom: Moderate	0	1	1	1
Any local symptom: Severe	0	0	0	0
Any local symptom: Did not report this event	3	2	4	2
Pain: Mild	3	4	9	4
Pain: Moderate	0	0	1	1
Pain: Severe	0	0	0	0
Pain: Did not report this event	3	2	4	2

Primary outcome: Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms

Time frame: 28 days following vaccination. Count of participants. Unit: Participants

Measure	Group 1: Low Dose n = 6	Group 2: Mid Dose n = 6	Group 3: High Dose - Single Dose n = 14	Group 3: High Dose - Two Doses n = 7
Cardiac disorders (vaccine-related)	0	2	0	0
Gastrointestinal disorders (vaccine-related)	1	1	1	0
General disorders and administration site reactions (vaccine-related)	0	2	2	1
Musculoskeletal and connective tissue disorders (vaccine-related)	0	0	3	0
Infections and infestations (vaccine-related)	0	0	0	1
Nervous system disorders (vaccine-related)	0	1	3	0
Reproductive system and breast disorders (vaccine-related)	0	0	0	0
Respiratory, thoracic and mediastinal disorders (vaccine-related)	2	2	1	2

Primary outcome: Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events

Time frame: Duration of the study (6 months). Count of participants. Unit: Participants

Measure	Group 1: Low Dose n = 6	Group 2: Mid Dose n = 6	Group 3: High Dose - Single Dose n = 14	Group 3: High Dose - Two Doses n = 7
Value	1	0	0	0

Primary outcome: Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities

Time frame: 28 days following vaccination. Count of participants. Unit: Participants

Measure	Group 1: Low Dose n = 6	Group 2: Mid Dose n = 6	Group 3: High Dose - Single Dose n = 14	Group 3: High Dose - Two Doses n = 7
Alanine transaminase: Normal	6	5	14	7
Alanine transaminase: Abnormal	0	1	0	0
Albumin: Normal	5	6	14	7
Albumin: Abnormal	1	0	0	0
Alkaline phosphatase: Normal	6	6	14	7
Alkaline phosphatase: Abnormal	0	0	0	0
Bilirubin: Normal	5	5	10	5
Bilirubin: Abnormal	1	1	4	2

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and systemic AEs were collected 7 days post each vaccination. Unsolicited adverse events were collected 28 days post each vaccination. Serious adverse events and adverse events of special interest were collected for each volunteer from their enrolment to their final visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Low Dose	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
Group 2: Mid Dose	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Group 3: High Dose 1	0 of 14 (0%)	12 of 14 (85.7%)	0 of 14
Group 4: High Dose 2	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39922207Jenkin D, Makinson R, Sanders H, Sampson A, Platt A, Tran N, Dinesh T, Mabbett R, Lawrie A, Quaddy J, Poulton I, Berrie E, Cicconi P, Lambe T. Safety and immunogenicity of a bivalent Ebola virus and Sudan virus ChAdOx1 vectored vaccine in adults in the UK: an open-label, non-randomised, first-in-human, phase 1 clinical trial. Lancet Microbe. 2025 May;6(5):101022. doi: 10.1016/j.lanmic.2024.101022. Epub 2025 Feb 5.
Individual participant dataSharing planned: No

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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.

Paola Cicconi, Dr. principal investigator

University of Oxford

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 ChAdOx1 biEBOV in people with Ebola, 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 7 inclusion and 24 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 4 Apr 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?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms (time frame: 7 days following vaccination). 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 NCT05079750, 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 4 Apr 2025.