* A study of a new vaccine against two types of Ebola

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    301075

  • Contact name

    Paola Cicconi

  • Contact email

    paola.cicconi@ndm.ox.ac.uk

  • Sponsor organisation

    University of Oxford / Clinical Trials and Research Governance (CTRG)

  • Eudract number

    2020-005853-26

  • Clinicaltrials.gov Identifier

    NCT05079750

  • Duration of Study in the UK

    0 years, 7 months, 9 days

  • Research summary

    Ebola is a highly lethal disease that occurs in periodic outbreaks in Sub Saharan African countries. Ebola outbreaks can be catastrophic. Healthcare workers are at particular risk of exposure and death during when they occur.
    Rather than being caused by a single species of virus, Ebola is caused by several distinct species of virus. Collectively these are known as “Ebolaviruses”.
    There have been very recent advances in Ebola vaccine development which have led to the approval of the first vaccines against Ebola by international medical regulators. However, these vaccines are currently only authorised for protection against a single Ebolavirus species. It is currently thought that a vaccine that only targets a single species of Ebolavirus might not fully protect against other Ebolavirus species.
    This study involves testing a new vaccine that is designed to simultaneously target two Ebolavirus species. The vaccine, ChAdOx1 biEBOV, targets the two deadliest Ebolaviruses: “Zaire Ebolavirus” and “Sudan Ebolavirus”. These have been responsible for nearly all Ebola outbreaks and deaths.The purpose of this study is to test ChAdOx1 biEBOV in a small group of healthy adult volunteers in the UK in order to assess safety and immunogenicity of the vaccine.
    We plan to recruit 26 people to take part in this study. All participants will be given one dose of ChAdOx1 biEBOV vaccine. We are testing three different doses of the vaccine in the trial and will split participants into 3 dose groups. Healthy volunteers aged 18-55 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 6 months. The study is funded by Innovate UK.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    22/SC/0306

  • Date of REC Opinion

    27 Aug 2021

  • REC opinion

    Favourable Opinion