TerminatedPhase 1

A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

Stopped: Long term follow up will take place in a new clinical trial.

United Kingdom38 participantsStarted 2015-05-06

Plain-language summary

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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adults aged 18 to 50 years * Able and willing (in the Investigator's opinion) to comply with all study requirements * Willing to allow the investigators to discuss the volunteer's medical history with their GP * For females only, willingness to practice continuous effective contraception (see section 6.3.3) during the study and a negative pregnancy test on the day(s) of screening and vaccination * Agreement to refrain from blood donation during the course of the study * Provide written informed consent Exclusion Criteria: * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period * Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus, or MVA vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data * Receipt of any live, attenuated vaccine within 28 days prior to enrolment * Receipt of any subunit or killed vaccine within 14 days prior to enrolment * Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; functional hyposplenism, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled an…

What they're measuring

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.

Timeframe: 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

Timeframe: 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.

Timeframe: 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

Timeframe: 28 weeks

Trial details

NCT IDNCT02451891

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-22

View on ClinicalTrials.gov More Ebola Virus Disease trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

Timeframe: 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

Timeframe: 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.

Timeframe: 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

Timeframe: 28 weeks