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

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

Call for proposal

H2020-JTI-IMI2-2014-02-single-stage
See other projects for this call

Coordinator

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
Address
Keppel Street
WC1E 7HT London
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 47 208 317,53

Participants (4)

JANSSEN VACCINES & PREVENTION BV
Netherlands
EU contribution
€ 0
Address
Archimedesweg 4
2333 CN Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 1 376 981,12
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 653 722,66
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
UNIVERSITY OF SIERRA LEONE
Sierra Leone
EU contribution
€ 9 097 863,69
Address
College Of Medecine & Allied Health Sciences University Of Sierra Leone New England
Freetown
Activity type
Higher or Secondary Education Establishments