NCT02240875

Brief Summary

The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. The investigators will do this by giving volunteers a either one or two vaccinations, doing blood and saliva tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use either of these vaccines in humans. We plan to recruit a total of 92 volunteers to be vaccinated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

September 17, 2014

Completed
2.9 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

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

September 10, 2014

Last Update Submit

July 4, 2018

Conditions

EbolaEbola Zaire

Keywords

EbolaZaire

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses

    The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

    6 months

Secondary Outcomes (1)

  • Cellular and humoral immunogenicity of the Ebola Zaire vaccine cAd3-EBO Z when administered to healthy volunteers at 3 doses

    6 months

Study Arms (13)

Group 1

EXPERIMENTAL

Single dose of cAd3-EBO Z at 1 x 10\^10 vp intramuscularly

Biological: cAd3-EBO Z at 1 x 10^10 vp

Group 1b

EXPERIMENTAL

Single dose of cAd3-EBO Z at 1 x 10\^10 vp intramuscularly, followed by 4.4x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 1 x 10^10 vpBiological: 4.4x10^8 TCID50s MVA-BN® Filo

Group 1c

EXPERIMENTAL

Single dose of cAd3-EBO Z at 1 x 10\^10 vp intramuscularly, followed by 2.2x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 1 x 10^10 vpBiological: 2.2x10^8 TCID50s MVA-BN® Filo

Group 2

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly

Biological: cAd3-EBO Z at 2.5 x 10^10 vp

Group 2b

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly, followed by 4.4x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 4.4x10^8 TCID50s MVA-BN® Filo

Group 2c

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly, followed by 2.2x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 2.2x10^8 TCID50s MVA-BN® Filo

Group 3

EXPERIMENTAL

Single dose of cAd3-EBO Z at 5 x 10\^10 vp intramuscularly

Biological: cAd3-EBO Z at 5 x 10^10 vp

Group 3b

EXPERIMENTAL

Single dose of cAd3-EBO Z at 5 x 10\^10 vp intramuscularly, followed by 4.4x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 5 x 10^10 vpBiological: 4.4x10^8 TCID50s MVA-BN® Filo

Group 3c

EXPERIMENTAL

Single dose of cAd3-EBO Z at 5 x 10\^10 vp intramuscularly, followed by 2.2x10\^8 TCID50s MVA-BN® Filo

Biological: cAd3-EBO Z at 5 x 10^10 vpBiological: 2.2x10^8 TCID50s MVA-BN® Filo

Group 4

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly at day 0, followed by 2.2 x 10\^8 TCID50s MVA-BN® Filo at day 7

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 2.2x10^8 TCID50s MVA-BN® Filo

Group 5

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly at day 0, followed by 2.2 x 10\^8 TCID50s MVA-BN® Filo at day 14

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 2.2x10^8 TCID50s MVA-BN® Filo

Group 6

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly at day 0, followed by 4.4 x 10\^7 TCID50s MVA-BN® Filo at day 7

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 4.4 x 10^7 TCID50s MVA-BN® Filo

Group 7

EXPERIMENTAL

Single dose of cAd3-EBO Z at 2.5 x 10\^10 vp intramuscularly at day 0, followed by 4.4 x 10\^7 TCID50s MVA-BN® Filo at day 14

Biological: cAd3-EBO Z at 2.5 x 10^10 vpBiological: 4.4 x 10^7 TCID50s MVA-BN® Filo

Interventions

cAd3-EBO Z at 1 x 10^10 vpBIOLOGICAL

Low dose cAd3-EBO Z

Group 1Group 1bGroup 1c
cAd3-EBO Z at 2.5 x 10^10 vpBIOLOGICAL

Medium dose cAd3-EBO Z

Group 2Group 2bGroup 2cGroup 4Group 5Group 6Group 7
cAd3-EBO Z at 5 x 10^10 vpBIOLOGICAL

High dose cAd3-EBO Z

Group 3Group 3bGroup 3c
4.4x10^8 TCID50s MVA-BN® FiloBIOLOGICAL

High dose MVA-BN® Filo

Group 1bGroup 2bGroup 3b
2.2x10^8 TCID50s MVA-BN® FiloBIOLOGICAL

Low dose MVA-BN® Filo

Group 1cGroup 2cGroup 3cGroup 4Group 5
4.4 x 10^7 TCID50s MVA-BN® FiloBIOLOGICAL

Very low dose MVA-BN® Filo

Group 6Group 7

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 general practitioner (GP)
  • For females only, willingness to practice continuous effective contraception 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 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; 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, (e.g. egg products) including urticaria, respiratory difficulty or abdominal pain
  • Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • Any history of anaphylaxis in reaction to vaccination
  • 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
  • Poorly controlled asthma or thyroid disease
  • Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
  • Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (2)

  • Lambe T, Rampling T, Samuel D, Bowyer G, Ewer KJ, Venkatraman N, Edmans M, Dicks S, Hill AV, Tedder RS, Gilbert SC. Detection of Vaccine-Induced Antibodies to Ebola Virus in Oral Fluid. Open Forum Infect Dis. 2016 Feb 22;3(1):ofw031. doi: 10.1093/ofid/ofw031. eCollection 2016 Jan.

    PMID: 27004234DERIVED

  • Ewer K, Rampling T, Venkatraman N, Bowyer G, Wright D, Lambe T, Imoukhuede EB, Payne R, Fehling SK, Strecker T, Biedenkopf N, Krahling V, Tully CM, Edwards NJ, Bentley EM, Samuel D, Labbe G, Jin J, Gibani M, Minhinnick A, Wilkie M, Poulton I, Lella N, Roberts R, Hartnell F, Bliss C, Sierra-Davidson K, Powlson J, Berrie E, Tedder R, Roman F, De Ryck I, Nicosia A, Sullivan NJ, Stanley DA, Mbaya OT, Ledgerwood JE, Schwartz RM, Siani L, Colloca S, Folgori A, Di Marco S, Cortese R, Wright E, Becker S, Graham BS, Koup RA, Levine MM, Volkmann A, Chaplin P, Pollard AJ, Draper SJ, Ballou WR, Lawrie A, Gilbert SC, Hill AV. A Monovalent Chimpanzee Adenovirus Ebola Vaccine Boosted with MVA. N Engl J Med. 2016 Apr 28;374(17):1635-46. doi: 10.1056/NEJMoa1411627. Epub 2015 Jan 28.

    PMID: 25629663DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Adrian V Hill

    University of Oxford

    PRINCIPAL INVESTIGATOR

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

September 10, 2014

First Posted

September 16, 2014

Study Start

September 17, 2014

Primary Completion

August 22, 2017

Study Completion

August 22, 2017

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

GB(1)