London School of Hygiene & Tropical Medicine

The trial, ZEBOVAC, will also generate knowledge about Ebola Virus Disease and its transmission, and perceptions and attitudes about the vaccine in a subset of participants. It will be undertaken at Epicentre Mbarara, Mbarara University of Science and Technology in Western Uganda and is sponsored by the London School of Hygiene & Tropical Medicine.

The vaccine regimen uses a ‘prime-boost’ approach where Ad26.ZEBOV is given as the first dose followed by MVA-BN-Filo 56 days later. This approach is designed to produce stronger and longer-lasting immune responses. The study aims to enrol 800 people including healthcare workers such as physicians, clinicians, nurses and pharmacists, and frontline workers such as cleaners, mortuary attendants and surveillance, ambulance and burial teams.

Other participants will include healthcare staff providing non-Ebola related care which places them in contact with patients at public and private health centres or clinics.

Frontline workers, particularly healthcare workers, are at increased risk of contracting Ebola. During the early phase of the 2014-2016 outbreak in West Africa, a study in Guinea found that up to 38% of the Ebola patients were healthcare workers, with hospital acquired infection transmissions likely in 12 of the 14 cases.

The Janssen investigational Ebola vaccine regimen has been tested in more than 6,000 people in Europe, United States and Africa - including Uganda - and is safe. Although it has not been used in previous outbreaks, and thus demonstration of efficacy in humans is lacking, it has shown outstanding safety and immunogenicity in humans and is highly protective against Ebola challenge in non-human primates.

Professor Pontiano Kaleebu, Director of the MRC/UVRI & LSHTM Uganda Research Unit and trial Principle Investigator, said: “A vaccine, alongside strong community engagement, strengthened diagnosis and real time sequencing, is key to controlling Ebola epidemics. Available vaccines have been used under study conditions as primary prevention or ring vaccination approaches, however currently there is no licensed Ebola vaccine for international use. Developing effective vaccines and treatments against Ebola are therefore global public health priorities. In this trial we hope to avail more information that will help us work towards having a licenced Ebola vaccine.”

Uganda has kept Ebola infections to a minimum through active surveillance, preparedness and swift containment despite an ongoing Ebola outbreak which was declared in the neighbouring Democratic Republic of Congo (DRC) over one year ago. In June 2019, Uganda registered its first Ebola case of the outbreak

ZEBOVAC is funded by Coalition for Epidemic Preparedness Innovations (CEPI) and is sponsored by the London School of Hygiene and Tropical Medicine. The vaccine regimen is provided inkind by Janssen. Both local and international investigators from Medical Research Council/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC/UVRI and LSHTM) Uganda Research Unit, Uganda Virus Research Institute, Epicentre- Mbarara & Paris, Mbarara University of Science & Technology and of Ministry of Health, Uganda are collaborating on the trial. The study team is further supported by the Ministry of Health (Uganda) and the EBODAC consortium.