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.
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
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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Cicconi, Dr., Principal investigator, University of Oxford
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