| Adults aged between 18 to 55 years (inclusive) at the time of screening.
Medically healthy, such that according to investigator judgement, hospitalisation within the study
period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable.
Able to attend the scheduled visits and to comply with all study procedures.
Willing and able to give informed consent for participation in the study.
Able to provide a reliable past medical history confirmed where necessary, at the investigator’s
discretion, by the participant’s usual health care provider.
Willing to allow usual health care provider, if appropriate, to be notified of participation in the study.
Agreement to refrain from planned blood donation during the study (see also section 8.6).
For participants of childbearing potential only (as defined by protocol section 11.9): willing to use highly effective contraception for the duration of the study AND to have a pregnancy test on the day of screening and vaccination days and at the end of study. Highly effective methods include contraceptive implant, injectable contraception, intrauterine device/system, surgical sterilisation, or another method
judged by the Investigator to be highly effective. The pregnancy tests taken prior to vaccination must be negative.
For cohort 3 only: Have previously received at least one dose of rVSV-ZEBOV-GP or rVSV-SEBOV-GP. |
Receipt of an investigational product within 12 weeks prior to enrolment or planned within the trial period.
Participation in another research study, in which procedures performed could compromise the integrity of this study such as exposure to a different study IMP or significant volumes of blood taken, or are planning to do so within the trial period. History of previous confirmed or suspected filovirus infection.
History of travel within 42 days of enrolment, or planned travel within the study period, to the Democratic Republic of the Congo.
For cohorts 1 and 2 only: Prior receipt of a vaccine targeting filoviruses, including licensed and investigational vaccines, confirmed by participant recall.
Prior receipt of a ChAdOx1- or ChAdOx2-vectored vaccine within 2 years of enrolment as confirmed by participant recall Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate.
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months, or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate).
History of anaphylaxis or severe reaction in relation to vaccination. 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.
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
History of any serious psychiatric condition likely to affect participation in the study. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the study.
History of a bleeding disorder (e.g., 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.
History of capillary leak syndrome.
History of Guillian-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome.
History of currently active autoimmune conditions of any severity requiring treatment or on-going medical follow-up.
Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological (including sickle cell disease), immunological, endocrine disorder, or neurological illness. Well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator.
Suspected or known current alcohol abuse, as per investigator’s discretion.
Suspected or known injecting drug use within the 5 years preceding enrolment.
Acute or chronic hepatitis B or hepatitis C infection.
Any clinically significant finding on screening that does not resolve (for example on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study*.
Any other significant disease, disorder or finding which may significantly increase the risk to the participant if included in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
Study staff or a partner or dependent child of study staff.
Use of traditional medicine within 3 months of enrolment in the study which, in the opinion of the investigator, could impact the integrity of the trial.
|
Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
55 Year(s) |
Both |