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EBOVAC1 SIGNED

Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen – Sofia ref.: 115854

Total Cost €

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EC-Contrib. €

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Partnership

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Project "EBOVAC1" data sheet

The following table provides information about the project.

Coordinator
LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER 

Organization address
address: KEPPEL STREET
city: LONDON
postcode: WC1E 7HT
website: http://www.lshtm.ac.uk/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Project website http://www.ebovac.org
 Total cost 98˙044˙689 €
 EC max contribution 58˙336˙885 € (60%)
 Programme 1. H2020-EU.3.1.7.13. (Other)
 Code Call H2020-JTI-IMI2-2014-02-single-stage
 Funding Scheme IMI2-RIA
 Starting year 2014
 Duration (year-month-day) from 2014-12-01   to  2021-11-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER UK (LONDON) coordinator 44˙720˙692.00
2    UNIVERSITY OF SIERRA LEONE SL (FREETOWN) participant 11˙524˙564.00
3    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 1˙437˙905.00
4    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR (PARIS) participant 653˙722.00
5    JANSSEN VACCINES & PREVENTION BV NL (LEIDEN) participant 0.00

Map

 Project objective

The overall aim of the EBOVAC programme is to assess the safety and efficacy of a novel prime boost prophylactic vaccine regimen against Ebola Virus Disease (EVD), which has been 100% effective in preclinical studies. This will be done via phase I, II and III trials carried out in the EU and in Africa, in response to the urgent public health need raised by the current Ebola epidemic. To expedite the development of the vaccine regimen, Phase II and Phase III trials will be carried out in parallel and therefore co-ordinated by two separate teams. Proposals responding to IMI2 Topic 1 will consequently be split into two parts. EBOVAC1 will address the Phase I and Phase III trials, whereas EBOVAC2 will address the Phase II trials.

EBOVAC1 will establish the initial safety and immunogenicity of the proposed heterologous prime/ boost regimen of Ad26.ZEBOV and MVA-BNFilo vaccine through phase I studies conducted in the UK, the US and currently Ebola- unaffected African countries. This will be done by administering the vaccine in different sequences and at different time intervals so as to identify the shortest schedule that is immunogenic and to maximize the potential for short term efficacy in affected countries. Initiation of these trials is expected to occur between December 2014 and March 2015 and approximately 300 subjects will be enrolled.

The main objective therefore of EBOVAC 2 is to provide extensive and robust data on the safety, immunogenicity and efficacy of the Ad26.ZEBOV and MVA-BN-Filo vaccine.

This will be done by:

1. Carrying out translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates (via WP4) 2. Carrying out Phase II trials in African and European volunteers in 6 countries, four in Africa and two in the EU with an overall target enrolment of approximately 1,500 subjects. Given the compressed nature of this development program, the Phase II studies will be conducted in parallel

 Deliverables

List of deliverables.
Publish Information Governance Policy Documents, reports 2019-04-02 13:36:04

Take a look to the deliverables list in detail:  detailed list of EBOVAC1 deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Chloé Pasin, Irene Balelli, Thierry Van Effelterre, Viki Bockstal, Laura Solforosi, Mélanie Prague, Macaya Douoguih, Rodolphe Thiébaut
Dynamics of the Humoral Immune Response to a Prime-Boost Ebola Vaccine: Quantification and Sources of Variation
published pages: , ISSN: 0022-538X, DOI: 10.1128/jvi.00579-19
Journal of Virology 93/18 2020-03-05
2019 Mario Jendrossek, W. John Edmunds, Hana Rohan, Samuel Clifford, Thomas A. Mooney, Rosalind M. Eggo
Health care worker vaccination against Ebola: Vaccine acceptance and employment duration in Sierra Leone
published pages: 1101-1108, ISSN: 0264-410X, DOI: 10.1016/j.vaccine.2018.12.060
Vaccine 37/8 2020-03-05
2019 Alexis Robert, W John Edmunds, Conall H Watson, Ana Maria Henao-Restrepo, Pierre-Stéphane Gsell, Elizabeth Williamson, Ira M Longini, Keïta Sakoba, Adam J Kucharski, Alhassane Touré, Sévérine Danmadji Nadlaou, Boubacar Diallo, Mamamdou Saidou Barry, Thierno Oumar Fofana, Louceny Camara, Ibrahima Lansana Kaba, Lansana Sylla, Mohamed Lamine Diaby, Ousmane Soumah, Abdourahime Diallo, Amadou Niar
Determinants of Transmission Risk During the Late Stage of the West African Ebola Epidemic
published pages: 1319-1327, ISSN: 0002-9262, DOI: 10.1093/aje/kwz090
American Journal of Epidemiology 188/7 2020-03-05
2019 Zacchaeus Anywaine, Hilary Whitworth, Pontiano Kaleebu, George Praygod, Georgi Shukarev, Daniela Manno, Saidi Kapiga, Heiner Grosskurth, Samuel Kalluvya, Viki Bockstal, Dickson Anumendem, Kerstin Luhn, Cynthia Robinson, Macaya Douoguih, Deborah Watson-Jones
Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania
published pages: 46-56, ISSN: 0022-1899, DOI: 10.1093/infdis/jiz070
The Journal of Infectious Diseases 220/1 2020-03-05
2019 Alexis Robert, Anton Camacho, W. John Edmunds, Marc Baguelin, Jean-Jacques Muyembe Tamfum, Alicia Rosello, Sakoba Kéïta, Rosalind M. Eggo
Control of Ebola virus disease outbreaks: Comparison of health care worker-targeted and community vaccination strategies
published pages: 106-114, ISSN: 1755-4365, DOI: 10.1016/j.epidem.2019.03.001
Epidemics 27 2020-03-05
2019 Gaudensia Mutua, Omu Anzala, Kerstin Luhn, Cynthia Robinson, Viki Bockstal, Dickson Anumendem, Macaya Douoguih
Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya
published pages: 57-67, ISSN: 0022-1899, DOI: 10.1093/infdis/jiz071
The Journal of Infectious Diseases 220/1 2020-03-05
2015 Anton Camacho, Rosalind M Eggo, Sebastian Funk, Conall H Watson, Adam J Kucharski, W John Edmunds
Estimating the probability of demonstrating vaccine efficacy in the declining Ebola epidemic: a Bayesian modelling approach
published pages: e009346, ISSN: 2044-6055, DOI: 10.1136/bmjopen-2015-009346
BMJ Open 5/12 2019-05-15
2016 An Vandebosch, Robin Mogg, Nele Goeyvaerts, Carla Truyers, Brian Greenwood, Debby Watson-Jones, Guillermo Herrera-Taracena, Wim Parys, Tony Vangeneugden
Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges
published pages: 57-65, ISSN: 1740-7745, DOI: 10.1177/1740774515621059
Clinical Trials: Journal of the Society for Clinical Trials 13/1 2019-05-15
2015 Rosalind M Eggo, Conall H Watson, Anton Camacho, Adam J Kucharski, Sebastian Funk, W John Edmunds
Duration of Ebola virus RNA persistence in semen of survivors: population-level estimates and projections
published pages: Volume 20, 2015, ISSN: 1025-496X, DOI: 10.2807/1560-7917.ES.2015.20.48.30083
Eurosurveillance 20/48 2019-05-15
2016 Adam J. Kucharski, Rosalind M. Eggo, Conall H. Watson, Anton Camacho, Sebastian Funk, W. John Edmunds
Effectiveness of Ring Vaccination as Control Strategy for Ebola Virus Disease
published pages: 105-108, ISSN: 1080-6040, DOI: 10.3201/eid2201.151410
Emerging Infectious Diseases 22/1 2019-05-15
2017 Rebecca L. Winslow, Iain D. Milligan, Merryn Voysey, Kerstin Luhn, Georgi Shukarev, Macaya Douoguih, Matthew D. Snape
Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara–Vectored Ebola Vaccines at 1 Year
published pages: 1075, ISSN: 0098-7484, DOI: 10.1001/jama.2016.20644
JAMA 317/10 2019-05-15
2018 Martinus A.H. Capelle, Lara Babich, J.P. Els van Deventer-Troost, Doris Salerno, Kelly Krijgsman, Ulrike Dirmeier, Britt Raaby, Janik Adriaansen
Stability and suitability for storage and distribution of Ad26.ZEBOV/MVA-BN®-Filo heterologous prime-boost Ebola vaccine
published pages: 215-221, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2018.06.001
European Journal of Pharmaceutics and Biopharmaceutics 129 2019-04-18
2018 Luisa Enria, Shelley Lees
Citizens, dependents, sons of the soil: Defining political subjectivities through encounters with biomedicine during the Ebola epidemic in Sierra Leone
published pages: , ISSN: 2405-691X, DOI: 10.17157/mat.5.4.512
Medicine Anthropology Theory | An open-access journal in the anthropology of health, illness, and medicine 5/4 2019-04-18
2018 Angus Fayia Tengbeh, Luisa Enria, Elizabeth Smout, Thomas Mooney, Mike Callaghan, David Ishola, Bailah Leigh, Deborah Watson-Jones, Brian Greenwood, Heidi Larson, Shelley Lees
“We are the heroes because we are ready to die for this country”: Participants\' decision-making and grounded ethics in an Ebola vaccine clinical trial
published pages: 35-42, ISSN: 0277-9536, DOI: 10.1016/j.socscimed.2018.03.008
Social Science & Medicine 203 2019-04-18

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