Community Research and Development Information Service - CORDIS

H2020

EBOVAC2 Report Summary

Project ID: 115861
Funded under: H2020-EU.3.1.7.13.

Periodic Reporting for period 2 - EBOVAC2 (Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen: Phase II)

Reporting period: 2016-01-01 to 2016-12-31

Summary of the context and overall objectives of the project

Combining the expertise and capabilities of global research institutions, non-government organizations and the pharmaceutical industry has been critical to help address the Ebola public health challenge.
The Ebola vaccine projects - EBOVAC1, EBOVAC2, EBODAC and EBOMAN - are a series of clinical trials and associated projects which aim to assess a novel 'prime-boost' (dual shot) preventive vaccine regimen against Ebola Virus Disease (EVD).
The EBOVAC2 project is conducting phase 2 clinical trials in Europe and Africa to assess the safety, tolerability and immunogenicity (immune response) of the heterologous prime-boost Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development by Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The vaccine regimen involves an initial dose that primes the immune system to develop disease-specific antibodies, followed by a booster dose at a later date with the goal of potentially strengthening and optimizing the duration of immunity.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Period 1 (Dec 2014 - Dec 2015) covered the start-up of the EBOVAC2 phase 2 trials.
Sites in Europe and Africa were selected, followed by the finalization of contracts and the start of verification of sites' capacities and training needs.
In parallel, the clinical trial protocols were submitted to the relevant health authorities and ethical committees to obtain regulatory authorizations.
The phase 2 trials were planned to start as soon as preliminary safety data from the EBOVAC1 phase 1 trials in the UK and Africa became available.
Regulatory authorities acknowledged these plans and accepted the phase 2 study protocols.
The first sites were opened in the UK, France and Africa and the first cohort was fully enrolled in the UK by the end of Period 1.
In parallel to trial implementation, preparations for the core and exploratory immunology studies also started during Period 1.
EBOVAC2 initiated the translational studies and carried out experiments on the natural history of the disease in animals.

In Period 2 (Jan-Dec 2016), additional sites in France and Africa were initiated in the first quarter of 2016 and enrollment commenced at all sites.
EBOVAC2 provided training to local staff as part of capacity building efforts. By the end of Period 2, enrollment was completed for cohorts 1 and 2 in the UK.
In France, enrollment for cohort 2 and for a sub-study reached 95% and 83% completion, respectively.
Cohort 3 enrollment is ongoing.
In Africa, 84% of cohort 1 volunteers (healthy adults) were randomized and the team is preparing to open cohorts 2a (HIV-positive individuals) and 2b (adolescents) at the beginning of period 3.
Other objectives of EBOVAC2 also advanced during Period 2, with the following main achievements:
* The early B cell response to the vaccine regimen was characterized in a subset of participants in the European trial (cohort 1, UK).
* A NHP bridging study was performed in the context of the translational studies.
* A clustering plan was developed to facilitate a link between all projects from the Ebola+ program that are willing to contribute to better preparedness in case of a next Ebola outbreak.
EBOVAC2 also contributes to the fully operational Central Information Repository that hosts data and project documentation from all Ebola+ projects.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Although the Ebola crisis in West Africa is over, the risk of a potential new outbreak in this region - or another area such as Central Africa - is real.
Such a significant threat requires a long-term commitment, including implementation of surveillance systems, rapid response preparedness and the development and availability of effective vaccines.
EBOVAC2 aims to provide the data to support the establishment of the safety and immunogenicity of a novel prime-boost vaccine regimen.
If the vaccine regimen is found to be safe and immunogenic, it may be possible - subject to regulatory approval - for it to be licensed for use as a preventive immunization strategy for health care workers and the general population in countries at risk of future outbreaks of EVD.
The economic costs of the last epidemic in West Africa were very high in the affected countries, but also in Europe where measures had to be taken to prevent importation of cases and to support the affected countries in Africa.
The development of an effective Ebola vaccine which provides sustained protection could have financial benefits for the people of Europe as well as those living in countries at risk of future outbreaks of EVD (UN Development Group, 2015).
Finally, the lessons learned from this project will have a positive impact on global strategies to develop vaccines quickly in situations of public health emergencies, thereby helping to improve the world's preparedness for emerging infectious diseases.

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