Ebola virus disease Infections and Infestations Ebola virus disease
Conditions
Interventions
The Senegalese study team will approach approximately 40 participants from a previous Ebola Vaccine study (EBL06). It is anticipated that approximately 50% of participants will be subsequently recruit
Sponsors
Oxford Tropical Research Ethics Committee (OxTREC), University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/07/2019: 1. Participants must have completed one of the Ebola vaccine immunisation schedules as part of the EBL06 study 2. Able and willing (in the Investigator’s opinion) to comply with all study requirements 3. For females only, willingness to use an effective form of contraception from the time of consent until 3 months after they have had the vaccine and a negative pregnancy test on the day(s) of screening and vaccination 4. Agreement to refrain from blood donation during the course of the study 5. Provide written informed consent Previous inclusion criteria: 1. Participants must have completed one of the Ebola vaccine immunisation schedules as part of the EBL06 study 2. Able and willing (in the Investigator’s opinion) to comply with all study requirements 3. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination 4. Agreement to refrain from blood donation during the course of the study 5. Provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned participation during the study period 2. Receipt of any live, attenuated vaccine within 28 days prior to enrolment 3. Receipt of any subunit or killed vaccine within 14 days prior to enrolment 4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) 6. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, (e.g. egg products) including urticaria, respiratory difficulty or abdominal pain 7. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema. 8. Any history of anaphylaxis in reaction to vaccination 9. Pregnancy, lactation or willingness/intention to become pregnant during the study 10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 11. History of current or previous psychiatric illness. 12. Poorly controlled asthma or thyroid disease 13. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years 14. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 15. Any other serious chronic illness 16. Current anti-tuberculosis prophylaxis or therapy 17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week 18. Suspected or known injecting drug abuse in the 5 years preceding enrolment 19. Seropositive for hepatitis B surface antigen (HBsAg) 20. History of contact with suspected, probable or confirmed cases of Ebola in the previous 21 days 21. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 22. 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 |
|---|---|
| Measured at 1 year following late booster dose of Ad26-ZEBOV: 1. Ebola GP specific IgG measured by ELISA 2. Ebola GP specific T cell cytokine response measured using ex vivo interferon-? enzyme-linked immunosorbent spot (ELISPOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and reactogenicity of late booster dose of Ad26-ZEBO The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed for both groups: 1. Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination 2. Occurrence of unsolicited adverse events for 28 days following the vaccination 3. Change from baseline for safety laboratory measures at 7 days following immunisation 4. Occurrence of serious adverse events for 1 year following immunisation Immunogenicity 1. Humoral - Ebola GP specific IgG measured by ELISA 2. Cellular - Ebola GP specific T cell cytokine response measured using ex vivo interferon-? enzyme-linked immunosorbent spot (ELISPOT) These secondary immunological endpoints will be determined at baseline, and at 7 and 28 days following immunisation. | — |
Countries
Senegal
Contacts
Public ContactSarah Kelly
Outcome results
None listed