Ebola
Conditions
Keywords
Ebola Virus Disease, Zaire Ebolavirus, EBOV, Sudan Ebolavirus, SUDV, Vaccine
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.
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.
Interventions
ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Sponsors
Study design
Eligibility
Inclusion criteria
1. Healthy adults aged 18 to 55 years. 2. Able and willing (in the Investigator's opinion) to comply with all study requirements. 3. 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. 4. Agreement to refrain from blood donation during the course of the study. 5. Provide written informed consent. 6. For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial. 7. For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
Exclusion criteria
1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period. 2. Receipt of a recombinant simian adenoviral vaccine prior to enrolment. 3. 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. 4. 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. 5. Previous receipt of an Ebolavirus vaccine. 6. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. 7. 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. 8. 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). 9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 10. History of anaphylaxis in relation to vaccination. 11. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 12. History of serious psychiatric condition likely to affect participation in the study. 13. Ongoing or planned pregnancy or breastfeeding during the trial follow up period. 14. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. 15. 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. 16. Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine). 17. Individuals who have previously experienced episodes of capillary leak syndrome. 18. Any other serious chronic illness requiring hospital specialist supervision. 19. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week. 20. Suspected or known injecting drug abuse in the 5 years preceding enrolment. 21. Detectable circulating hepatitis B surface antigen (HBsAg). 22. Seropositive for hepatitis C virus (antibodies to HCV). 23. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis. 24. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | At day 28 | 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. |
| Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | 14 days post final vaccine for each group | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Low Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^9 vp
ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 6 |
| Group 2: Mid Dose n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5x10\^10 vp
ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 6 |
| Group 3: High Dose - Single Dose n=7 participants vaccinated with a single dose of ChAdOx1 biEBOV 5x10\^10 vp
ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 7 |
| Group 3: High Dose - Two Doses n=7 participants vaccinated with two doses twelve weeks apart of ChAdOx1 biEBOV 5x10\^10 vp
ChAdOx1 biEBOV: ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | 7 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1: Low Dose | Group 2: Mid Dose | Group 3: High Dose - Single Dose | Group 3: High Dose - Two Doses | Total |
|---|---|---|---|---|---|
| Age, Customized | 24 years | 26 years | 20 years | 30 years | 28 years |
| Race/Ethnicity, Customized Asian or Asian British | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black Carribean and Mixed White or | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other Asian Background | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 4 Participants | 4 Participants | 7 Participants | 21 Participants |
| Region of Enrollment United Kingdom | 6 Participants | 6 Participants | 7 Participants | 7 Participants | 26 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 14 | 0 / 7 |
| other Total, other adverse events | 6 / 6 | 5 / 6 | 12 / 14 | 5 / 7 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 | 0 / 14 | 0 / 7 |
Outcome results
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.
Time frame: 28 days following vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Normal | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Abnormal | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Normal | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Normal | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Abnormal | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Normal | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Abnormal | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Normal | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Abnormal | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Abnormal | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Normal | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Abnormal | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Normal | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Normal | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Abnormal | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Abnormal | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Abnormal | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Normal | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Abnormal | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Abnormal | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Normal | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Normal | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Normal | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Normal | 10 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Abnormal | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Normal | 10 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Abnormal | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Abnormal | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Normal | 12 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Abnormal | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Normal | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Abnormal | 8 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Normal | 9 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Abnormal | 5 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Normal | 13 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Abnormal | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Normal | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Sodium | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Abnormal | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Potassium | Normal | 5 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Normal | 5 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Creatinine | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | White blood cell count | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Neutrophil count | Abnormal | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Abnormal | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Bilirubin | Normal | 5 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Normal | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alkaline phosphatase | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Alanine transaminase | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Eosinophil count | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Platelet count | Abnormal | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Hemoglobin | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Urea | Normal | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Albumin | Abnormal | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Clinical Laboratory Abnormalities | Lymphocyte count | Normal | 7 Participants |
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)
Time frame: Duration of the study (6 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Serious Adverse Events | 0 Participants |
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.
Time frame: 7 days following vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Did not report this event | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Mild | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Did not report this event | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Mild | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Did not report this event | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Mild | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Mild | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Did not report this event | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Mild | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Did not report this event | 4 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Mild | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Moderate | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Did not report this event | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Did not report this event | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Did not report this event | 6 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Did not report this event | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Mild | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Did not report this event | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Did not report this event | 5 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Mild | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Moderate | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Did not report this event | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Mild | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Moderate | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Did not report this event | 4 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Mild | 3 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Moderate | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Did not report this event | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Mild | 3 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Did not report this event | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Mild | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Mild | 3 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Mild | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Moderate | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Did not report this event | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Mild | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Did not report this event | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Moderate | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Did not report this event | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Moderate | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Did not report this event | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Did not report this event | 5 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Did not report this event | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Mild | 4 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Mild | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Did not report this event | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Mild | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Moderate | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Did not report this event | 6 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Severe | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Did not report this event | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Mild | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Moderate | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Did not report this event | 12 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Mild | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Moderate | 10 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Did not report this event | 3 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Did not report this event | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Moderate | 5 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Mild | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Did not report this event | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Moderate | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Did not report this event | 9 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Mild | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Moderate | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Mild | 9 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Moderate | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Mild | 9 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Moderate | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Did not report this event | 10 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Did not report this event | 4 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Mild | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Moderate | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Mild | 6 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Severe | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Did not report this event | 14 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Mild | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Mild | 4 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Did not report this event | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Mild | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Mild | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Moderate | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Moderate | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Moderate | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any local symptom | Did not report this event | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fever | Mild | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Mild | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Mild | 4 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Did not report this event | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Did not report this event | 4 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Moderate | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Did not report this event | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Did not report this event | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Moderate | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Mild | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Did not report this event | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Pain | Did not report this event | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Mild | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Any systemic symptom | Mild | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Moderate | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Itch | Did not report this event | 7 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Did not report this event | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Did not report this event | 5 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Redness | Mild | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Malaise | Did not report this event | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Headache | Did not report this event | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Feverishness | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Warmth | Did not report this event | 6 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Fatigue | Severe | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Solicited Local and Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
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)
Time frame: 28 days following vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-related) | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-related) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-related) | 2 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-unrelated) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-unrelated) | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-unrelated) | 3 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-unrelated) | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-unrelated) | 0 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-unrelated) | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-unrelated) | 1 Participants |
| Group 1: Low Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-unrelated) | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-related) | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-unrelated) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-unrelated) | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-unrelated) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-unrelated) | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-unrelated) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-related) | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-unrelated) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-related) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-related) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-related) | 0 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-related) | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-unrelated) | 1 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-related) | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-unrelated) | 2 Participants |
| Group 2: Mid Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-related) | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-related) | 3 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-related) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-unrelated) | 3 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-related) | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-unrelated) | 5 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-unrelated) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-unrelated) | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-unrelated) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-unrelated) | 3 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-unrelated) | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-related) | 1 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-unrelated) | 0 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-related) | 2 Participants |
| Group 3: High Dose - Single Dose | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-related) | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-unrelated) | 4 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Respiratory, thoracic and mediastinal disorders (vaccine-related) | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-related) | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-unrelated) | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-unrelated) | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Infections and infestations (vaccine-related) | 1 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Gastrointestinal disorders (vaccine-unrelated) | 3 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Nervous system disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | General disorders and administration site reactions (vaccine-unrelated) | 2 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Reproductive system and breast disorders (vaccine-unrelated) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Cardiac disorders (vaccine-unrelated) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-related) | 0 Participants |
| Group 3: High Dose - Two Doses | Safety and Tolerability of ChAdOx1 biEBOV in Healthy Volunteers: Number of Participants With Occurrence of Unsolicited Signs and Symptoms | Musculoskeletal and connective tissue disorders (vaccine-unrelated) | 0 Participants |
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.
Time frame: 14 days post final vaccine for each group
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Low Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to EBOV | 0.0300 frequency (proportion of parent cells) |
| Group 1: Low Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to SUDV | 0.0320 frequency (proportion of parent cells) |
| Group 2: Mid Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to SUDV | 0.0340 frequency (proportion of parent cells) |
| Group 2: Mid Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to EBOV | 0.0000 frequency (proportion of parent cells) |
| Group 3: High Dose - Single Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to EBOV | 0.0850 frequency (proportion of parent cells) |
| Group 3: High Dose - Single Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to SUDV | 0.1120 frequency (proportion of parent cells) |
| Group 3: High Dose - Two Doses | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to EBOV | 0.1190 frequency (proportion of parent cells) |
| Group 3: High Dose - Two Doses | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Cellular Immunogenicity | Antigen-specific CD8+ T cells to SUDV | 0.0485 frequency (proportion of parent cells) |
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.
Time frame: At day 28
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Low Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-EBOV antibody titers (occurred at D28) | 63.3 ELISA units |
| Group 1: Low Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-SUDV antibody titers (occurred at D28) | 27.0 ELISA units |
| Group 2: Mid Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-SUDV antibody titers (occurred at D28) | 101.7 ELISA units |
| Group 2: Mid Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-EBOV antibody titers (occurred at D28) | 164.2 ELISA units |
| Group 3: High Dose - Single Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-EBOV antibody titers (occurred at D28) | 260.1 ELISA units |
| Group 3: High Dose - Single Dose | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-SUDV antibody titers (occurred at D28) | 111.5 ELISA units |
| Group 3: High Dose - Two Doses | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-EBOV antibody titers (occurred at D28) | 1169.7 ELISA units |
| Group 3: High Dose - Two Doses | Immunogenicity of ChAdOx1 biEBOV in Healthy Adult Volunteers: Measure of Humoral Immunogenicity | Peak anti-SUDV antibody titers (occurred at D28) | 568.0 ELISA units |