Re-evaluating Optimal Vaccine Schedules Against Ebola (REVOLVE)

Phase 2

• Conditions: Ebola virus infection; Infections and Infestations

• Registration Number: ISRCTN10481319
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-17
• Last Update Posted: 21 September 2020
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Participants must have completed one of the following Ebola vaccine immunisation schedules; ChAd3-EBO-Z + Ad26.ZEBOV (or vice-versa), ChAd3-EBO-Z +/- MVA–BN-FILO or ChAd3-EBO-Z + MVA-EBO-Z
2. Willing and able to give written informed consent for participation in the study
3. In good health as determined by medical history, physical examination and clinical judgement of the investigators
4. Females of childbearing potential: willing to use effective contraception (the oral contraceptive pill, contraceptive implant, contraceptive injection, intrauterine device, intrauterine hormone-releasing systems (IUS) barrier methods, vasectomized partner or abstinence) from one month prior to three months after the vaccine. Vaccination will be delayed in female participants who have not used effective contraception for one month prior to Visit 1*
5. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards*
6. Willing to allow his or her General Practitioner to be notified of participation in the study
7. Agree to be registered on the Trial Over-Volunteering Prevention Service (TOPS) and agree to provide their National Insurance number or passport number (if not a British citizen) for the purposes of registration*
8. Agree to provide National Insurance number and Bank details for reimbursement purposes
* Participants intending to receive booster dose only

Exclusion Criteria

1. History of malignancy
2. Pregnancy or breastfeeding
3. New significant medical or surgical history since completion of the previous study (based on participant recall)
4. Receipt or planned receipt of adenovirus based vaccine since the parent Ebola vaccine studies
5. Chronic or recurrent use of medication which modify host immune response
6. Any contraindication to venepuncture, as determined by clinical judgement
7. History of allergy or anaphylaxis to a vaccine or any component within the vaccines used in this study (booster group only)
8. Have any known or suspected impairment or alteration of immune function, resulting from, for example:
8.1. Congenital or acquired immunodeficiency
8.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
8.3. Autoimmune disease
8.4. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (10mg daily or higher) or any systemic corticosteroid (or equivalent) treatment within 14 days prior to vaccination, or for more than 7 days consecutively within the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified