A Study of a New Vaccine Against Two Types of Ebola

NCT05079750 | Completed Phase 1 Results DMC

• 1 other identifier: EBL07
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ebola

Keywords

Ebola Virus Disease; Zaire Ebolavirus; EBOV; Sudan Ebolavirus; SUDV; Vaccine

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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)

  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.

  28 days following vaccination

Secondary Outcomes (2)

• Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity

  At day 28

• Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity

  14 days post final vaccine for each group

Study Arms (3)

Group 1: Low Dose

EXPERIMENTAL

n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp

Biological: ChAdOx1 biEBOV

Group 2: Mid Dose

EXPERIMENTAL

n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp

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

Biological: ChAdOx1 biEBOV

Interventions

ChAdOx1 biEBOV BIOLOGICAL

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

Group 1: Low Dose; Group 2: Mid Dose; Group 3: High Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39922207 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Results Point of Contact

• Title: Dr. Paola Cicconi
• Organization: University of Oxford

paola.cicconi@ndm.ox.ac.uk

01865 611425

Study Officials

• Paola Cicconi, Dr.

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: November 11, 2021
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)