The first Ebolavirus Zaire (EBOV) outbreak of 2014 was declared on 22nd of March in Guinea and as of 28th of September, the epidemic had spread to Liberia, Sierra Leone, Nigeria and Senegal.

On 7th of August 2014, the WHO requested that GSK “fully engage in WHO-coordinated efforts to test, license and make available safe and effective Ebola interventions” to assist in the control of the outbreak.

When in October 2014, the European Commission (EC) announced that it would provide funding as part of its Horizon 2020 (H2020) funding initiative to support research into treatments and vaccines for Ebola, a consortium was formed including GSK and three leading research institutions: The University of Oxford (UOXF), Bernhard Nocht Institute for Tropical Medicine (BNITM) and the Hospices Cantonaux CHUV (CHUV). The overall goal of the EbolaVac consortium is to help further advance development of a candidate vaccine against Ebola CHAD-EBO-Z, which is being co-developed by GSK and the US National Institutes of Health (NIH).

The consortium is backed by funding of €15.1 million from the European Commission Directorate General for Research and Innovation as part of its dedicated Horizon 2020 program supporting research into treatments and vaccines for Ebola and also expects to receive an additional €1.4 million from the Swiss government.

Taking into account the early stage of development of the GSK Chimpanzee Adenovirus Type 3 Ebolavirus Zaire (ChAd3-EBO Z) vaccine candidate, EbolaVac seeks to accelerate the clinical development of the vaccine for use in the containment of future EBOV outbreaks. This will be achieved by:

  1. Completing Phase I development of the ChAd3-EBO Z vaccine by supporting a clinical Phase I/II study conducted in Lausanne, Switzerland;
  2. Evaluating the ChAd3-EBO Z vaccine in (placebo)-controlled, observer-blind Phase II testing on adults and children at established clinical study centers in West Africa outside the current most heavily affected countries of Guinea, Sierra Leone, and Liberia;
  3. Investigating immunological effects of vaccination and the effect of booster vaccination;
  4. Accelerate the development of a suitable cGMP process for the bio-manufacture of MVA-GSK EBOZ on a cell line.

EbolaVac started in October 2014 and will run for 3 years.

The EbolaVac project is structured around seven work packages. This reflects the actions that are to be performed by the Consortium in order to answer the stated objectives.

WP1

Project Management

WP2

Phase 1/2 Lausanne Study

WP3

Phase 2 RCT in African countries

WP4

Booster Study and Immunology

WP5

Data Management and Data Analysis

WP6

Communication and Dissemination

WP7

Advanced cell line process development

Diagram illustrating the structure of the EbolaVac project:

  • RCT= Randomized-controlled Trial;
  • WP= Work Package.

The Phase I/II randomised-controlled study conducted in Lausanne, Switzerland (WP2) is sponsored by the CHUV and together with other out-of-project Phase I studies, evaluates the safety, reactogenicity and immunogenicity of the vaccine and select a dose to be used in Phase II trials. Immunised participants are WHO staff, members of humanitarian organisations and not possibly exposed subjects. This study started in October 2014.

The (placebo) controlled, observer-blind Phase II trial (WP3) will take place in West African countries presently outside of the outbreak zone. This trial will be sponsored by GSK and will enroll approximately 3000 adults to better assess safety and reactogenicity of the vaccine.

The controlled, observer-blind paediatric Phase II trial (WP3) will take place in West African countries presently outside of the outbreak zone. This trial will be sponsored by GSK and will enroll approximately 600 children 1 to <18 years of age to assess safety, reactogenicity, and immunogenicity of the vaccine in children.

A dedicated immunological expertise will be necessary for all studies, together with the conduct of an anticipated booster vaccination study. All this will be performed in WP4.

The accelerated development of a suitable cGMP process for the biomanufacture of MVA-GSK EBOZ on a cell line will be the focus of WP7.

Data management and data analysis will be conducted in a horizontal work package (WP5).

Communication and dissemination of results (WP6) is to take place throughout the duration of the project, and strategies for exploitation, including the securing of intellectual property rights, will be developed and implemented together with the EC and project participants.

WP1 is dedicated to project management and coordination. Effective and harmonised project governance will be ensured through the setup of operational, scientific and monitoring bodies and through the guidance of a joint steering committee with decision-making and control functions.