Not provided
Not provided
Not provided
Not provided
Not provided
Long term follow up will take place in a new clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a clinical trial in which healthy volunteers will be administered experimental Ebola vaccines. The investigators will vaccinate four groups of volunteers.
Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu.
Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4).
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Oxford and London England. The study will be funded by the Wellcome Trust.
It is important to answer this question to understand how best to deploy the vaccine in an outbreak setting, and to give an indication as to whether booster vaccinations may need to be considered to maintain immunity.
In light of this, the extension study has invited volunteers to attend some further optional follow up visits. It would involve obtaining some further blood tests to look for the same markers of vaccine induced immune response that were looked for in the first part of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a | Active Comparator | MVA-EBO Z (1 x 10^8 pfu) |
|
| Group 1b | Active Comparator | MVA-EBO Z (1.5 x 10^8 pfu) |
|
| Group 2 | Active Comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 14 days |
|
| Group 3 | Active Comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1 x 10^8 pfu) after 28 days |
|
| Group 4 | Active Comparator | ChAd3-EBO Z (2.5 +/- 1.2 x 10^10 vp) and MVA-EBO Z (1.5 x 10^8 pfu) after 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-EBO Z | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the first-in-human administration of MVA-EBO Z alone. This will be done by recording the number of participants who experience adverse events. | 24 weeks | |
| Safety and tolerability of the first-in-human administration of MVA-EBO Z . This will be done by recording the severity of adverse events | 24 weeks | |
| Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the number of participants who experience adverse events. | 28 weeks | |
| Safety and tolerability of the heterologous prime followed by MVA-EBO Z. This will be done by recording the severity of adverse events | 28 weeks |
Not provided
Not provided
Inclusion Criteria:
Healthy adults aged 18 to 50 years
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30407513 | Derived | Venkatraman N, Ndiaye BP, Bowyer G, Wade D, Sridhar S, Wright D, Powlson J, Ndiaye I, Dieye S, Thompson C, Bakhoum M, Morter R, Capone S, Del Sorbo M, Jamieson S, Rampling T, Datoo M, Roberts R, Poulton I, Griffiths O, Ballou WR, Roman F, Lewis DJM, Lawrie A, Imoukhuede E, Gilbert SC, Dieye TN, Ewer KJ, Mboup S, Hill AVS. Safety and Immunogenicity of a Heterologous Prime-Boost Ebola Virus Vaccine Regimen in Healthy Adults in the United Kingdom and Senegal. J Infect Dis. 2019 Apr 8;219(8):1187-1197. doi: 10.1093/infdis/jiy639. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ChAd3-EBO Z |
| Biological |
|
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |