NCT02451891

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2017

Completed
Last Updated

December 18, 2025

Status Verified

August 1, 2016

Enrollment Period

2.3 years

First QC Date

May 7, 2015

Last Update Submit

December 11, 2025

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (5)

Group 1a

ACTIVE COMPARATOR

MVA-EBO Z (1 x 10\^8 pfu)

Biological: MVA-EBO Z

Group 1b

ACTIVE COMPARATOR

MVA-EBO Z (1.5 x 10\^8 pfu)

Biological: MVA-EBO Z

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

Biological: MVA-EBO ZBiological: ChAd3-EBO Z

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

Biological: MVA-EBO ZBiological: ChAd3-EBO Z

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

Biological: MVA-EBO ZBiological: ChAd3-EBO Z

Interventions

MVA-EBO ZBIOLOGICAL
Group 1aGroup 1bGroup 2Group 3Group 4
ChAd3-EBO ZBIOLOGICAL
Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of an anaphylactic reaction
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • History of coeliac disease
  • Poorly controlled asthma or thyroid disease
  • Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30407513DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 22, 2015

Study Start

May 6, 2015

Primary Completion

August 22, 2017

Study Completion

August 22, 2017

Last Updated

December 18, 2025

Record last verified: 2016-08

Locations

GB(1)