Re-evaluating optimal vaccine schedules against Ebola in Senegal

Phase 2

Completed

• Conditions: Ebola virus disease; Infections and Infestations

• Registration Number: ISRCTN15434137
• Lead Sponsor: Oxford Tropical Research Ethics Committee (OxTREC), University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-12
• Study Completion: 2020-10-21
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified