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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 4 - EBOVAC2 (Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen: Phase II - Sofia ref.: 115861)

Teaser

Summary

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, EBOVAC3, EBODAC and EBOMAN - are a series of clinical trials and associated projects which aim to assess a novel 2-dose 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 2-dose vaccine regimen (Ad26â„¢.ZEBOV and MVA-BNâ„¢-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 second dose at a later date with the goal of potentially strengthening and optimizing the duration of immunity.

Work performed

EBOVAC2 has implemented two phase 2 trials in clinical sites in Europe and Africa after the finalization of contracts and verification of sites\' capacities and training needs. 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. Sites in the UK, France and Africa started enrolment in 2015.

In 2016, the Phase 2 trial in the EU progressed well and enrolment was completed for Cohorts 1 and 2 in the UK. In France, enrolment for Cohort 2 and for a sub-study reached 95% and 83% completion, respectively. Cohort 3 enrolment was ongoing. In Africa, 84% of Cohort 1 volunteers (healthy adults) were randomized and the team prepared to open Cohorts 2a (HIV-positive individuals) and 2b (adolescents) at the beginning of 2017.
In addition, the early response to the vaccine regimen was characterized in a subset of participants in the European trial (Cohort 1, UK).EBOVAC2 developed a plan to facilitate a link between all projects from the IMI Ebola+ program to contribute to better preparedness in case of future Ebola outbreaks. The consortium also contributed to the Central Information Repository that hosts information assets and project documentation from all IMI Ebola+ projects.

In 2017, enrolment in the Phase 2 study in Europe was completed and most sites initiated their closing process. In the Phase 2 study in Africa, enrolment in all cohorts was completed. In addition, progress was made in the validation of immunogenicity assays to be able to start the analysis of the clinical samples and generation of Phase 2 data.

In 2018, the work proceeded as planned. The clinical sites in Europe were closed. In Africa, only Cohort 3 and the 90 volunteers who agreed to participate in the booster dose sub-study were still in the final follow-up stage. For all other cohorts, volunteers had entered the long-term safety extension study (outside the scope of EBOVAC2). Preliminary safety and core immunogenicity results of both Phase 2 studies became available and were presented to the European and African Principal Investigators end of 2018. More data is currently being generated and final analyses and clinical study reports are expected in 2019. All immunogenicity response data will be combined into one integrative model. The workshop on vaccine clinical trial methodology was successfully organized in Burkina Faso for West African young medical researchers in January 2018.

The consortium is confident that the project will enter 2019 well prepared to finalize the Phase 2 sample analyses and start to work on the dissemination of results through future conferences and publications.

Final results

The risk to global public health posed by the Ebola virus was reinforced in 2018, when the Democratic Republic of the Congo (DRC) experienced two unrelated outbreaks of the disease. The second outbreak, which began in August 2018 only days after the first was declared over and has continued into 2019, is now the second biggest recorded outbreak of Ebola.

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 establish the safety and immunogenicity of a novel 2-dose vaccine regimen. If the vaccine regimen is found to be safe and immunogenic, it may be possible 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.