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Bringing a prophylactic Ebola vaccine to licensure

Periodic Reporting for period 1 - EBOVAC3 (Bringing a prophylactic Ebola vaccine to licensure)

Reporting period: 2018-06-01 to 2019-05-31

EBOVAC3 is one of the IMI2-Ebola+ vaccine projects focused on supporting the development of an investigational two-dose preventive vaccine regimen against Ebola Virus Disease (EVD) being advanced by Janssen Vaccines & Prevention B.V. part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and its partner Bavarian Nordic A/S. The projects are EBOVAC1, EBOVAC2, EBOVAC3, EBODAC and EBOMAN.

Tremendous progress has been made in the development of this vaccine regimen, in large part due to the contributions made through the above-named IMI-funded projects. EBOVAC3 aims to build on this progress to progress the vaccine regimen to licensure, which would result in an increased readiness to respond to or prevent future outbreaks of Ebola.

The EBOVAC3 project is conducting clinical trials of the vaccine regimen which will generate supportive data for licensure. The project is also preparing for future outbreaks through activities including mathematical modelling and social science research.
During the first year the EBOVAC3 project has been focused on set-up activities for the clinical trials and preparedness activities.

EBOVAC3 is preparing to conduct three clinical trials of the two-dose Ebola vaccine regimen.

EBL2005: Safety and immunogenicity study of the two-dose heterologous vaccine in healthy infants in Guinea and Sierra Leone.

EBL2007: Open-label safety and immunogenicity study of the two-dose heterologous vaccine regimen in health care providers in the Democratic Republic of Congo.

EBL3005: Long-term safety and immunogenicity study of the two-dose heterologous vaccine regimen in Sierra Leone.

For all three trials study documents including protocols and informed consent forms were developed and submitted to the relevant ethics and regulatory authorities. Study sites in Guinea, Sierra Leone and the Democratic Republic of Congo were identified and site logistical preparations such as staff recruitment and training were carried out. All three trials are expected to begin in Q3 of 2019.

EBOVAC3’s outbreak preparedness activities have also been in a set-up phase in the first year of the project. These activities will assess preparedness at the community, government and regulatory levels in countries previously affected by Ebola. Research protocols have been developed for social science research in Guinea and Sierra Leone into community understanding, expectations and acceptance of various Ebola vaccine strategies. Separate research protocols have also been drafted for a study of regulatory authorities’ experiences of studying an Ebola vaccine during an epidemic, and a study to identify gaps in preparedness for a future outbreak in Guinea, Sierra Leone and the Democratic Republic of Congo. Staff have been recruited to lead these research activities, which will be implemented in the second project year.

The mathematical modelling work is building on progress made in EBOVAC1 and EBOVAC2. Modelling of potential trial designs in future outbreaks has commenced; and work has begun to evaluate the effect of different vaccination approaches (e.g. mass, ring and targeted) to inform the design of efficient Ebola vaccination strategies in the future.

The EBOVAC3 project is now transitioning to the implementation phase in the second project year.
The second-largest ever outbreak of Ebola has been affecting eastern provinces of the Democratic Republic of Congo throughout the first year of the EBOVAC3 project, and there are ongoing calls from the global health community for more than one vaccine against the disease to be utilized in expanded efforts to control and contain the outbreak – particularly since the World Health Organization declared the outbreak a Public Health Emergency of International Concern (PHEIC) in July 2019.

The work of the EBOVAC family of projects is therefore as important as ever to the global fight against Ebola. Crucially, the data gathered from the clinical trials implemented by the EBOVAC3 project could contribute to the licensure of the 2-dose vaccine regimen, which in turn would help to expedite its use to combat or prevent future outbreaks of Ebola.

In anticipation of a licensed vaccine, the preparedness activities will inform understanding of how best to deploy the vaccine to fight Ebola in ways that are acceptable to communities, and meet the expectations and capacities of governments and regulatory authorities.

The economic and social costs of combatting an Ebola epidemic are huge for both affected countries and international responders, including countries in the European Union who mobilize and provide humanitarian aid. One estimate of the total economic and social burden from the 2014-2016 West Africa Ebola outbreak was a staggering $53 billion . The licensure of an effective vaccine which offers long-lasting protection against Ebola could therefore have a significant impact in countries at risk of the virus, but also for the people of Europe.