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Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen: Phase II - Sofia ref.: 115861

Project description

Advancing Ebola vaccine research and evaluation

Ebola is a viral disease that can cause severe illness and has the potential to be fatal. The 2014-to-2018 disease outbreaks in Africa underlined the need for vaccine development and led to the launch of the IMI Ebola+ programme which funded Ebola research projects. The EU-funded EBOVAC2 project aims to test the safety, immunogenicity and efficacy of two prophylactic Ebola vaccines in a number of clinical trials in Europe and Africa. The safety and efficacy of the two-dose vaccine regimen will also be evaluated in children, the elderly and individuals with HIV. Moreover, translational work in non-human primates will provide valuable information of the immune responses necessary to protect against Ebola.

Objective

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 with the planned Phase III study (EBOVAC1). The phase II studies will be placebo-controlled and will be conducted in locations where it is possible to perform carefully controlled safety studies (via WP2).
3. Evaluating the use of the vaccine in special population groups, such as children (ages 1-17 years), the elderly (ages 50-65) and individuals infected with HIV, to confirm safety and immunogenicity.
It is intended that Phase II trials will begin as soon as safety data are available from Phase I trials (via WP2).
4. Monitoring and characterising immune response to the proposed vaccine (via WP3).
5. Boosting the capacity of African centres, staff and infrastructure in preparation for Phase III studies and communicating and disseminating widely the results of EBOVAC2 as they become available to all key stakeholders (via WP6).
6. Contributing all data to the Central Information Repository for use by other Ebola programme projects as well as the wider community (via WP5).

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

IMI2-RIA - Research and Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-JTI-IMI2-2014-02-single-stage

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Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 15 057 160,80
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 15 631 410,80

Participants (8)

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