Ebola virus infection Infections and Infestations
Conditions
Interventions
This is a Phase 2, multi-centre, open-label, follow-on study of clinical trials of investigational vaccines against Ebola.
The participants for this study will be volunteers from prev
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Humoral and cellular immunity against Ebola virus glycoprotein at baseline and at 1 year following a late booster dose of Ad26-ZEBOV administered 2 to 5 years after receiving heterologous prime/boost of ChAd3- EBO Z /MVA –EBO Z and at the same time points (baseline and 1 year post-baseline) in participants who opt not to receive a booster dose of Ad26-ZEBOV. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and reactogenicity of late booster dose of Ad26-ZEBO: 1. Occurrence of solicited systemic reactogenicity signs and symptoms for 3 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 3 days following immunisation 4. Occurrence of serious adverse events for 1 year following immunisation Immunogenicity: 1. Humoral - Ebola GP specific IgG as 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, 7 days (added 04/06/2019), 28 days and 1 year following immunisation (baseline and 1 year for those opting not to receive a booster in this study) | — |
Countries
United Kingdom
Outcome results
None listed