Summary
While EBOVAC1 conducted pilot studies in Europe regarding the vaccine regimen Ad26.ZEBOV and MVA-BN-Filo followed by phase 2 studies in Africa, EBOVAC2 expanded on this work by conducting clinical trials exploring the safety profile of the vaccine candidates, evaluating safety and immunogenicity in children, the elderly and HIV positive people, and investigating the safety and immunogenicity of a booster dose in adults.
The vaccination regimen that the EBOVAC projects were researching involved two doses: the initial dose stimulates the immune system to develop disease-specific antibodies, while a second dose administered two months later is delivered with the goal of potentially strengthening and optimising the duration of immunity.
A key result from the EBOVAC2 project was that the vaccine regimen was found to be safe and immunogenic in healthy adults and HIV-positive adults, children and adolescents. The studies showed that the vaccine regimen could induce the body’s immune system memory, meaning that the body would remember the virus and rapidly respond if it came into contact with Ebola. The studies also determined the optimal interval time between the two vaccinations, i.e. 56 days.
Integrative statistical analyses were also conducted to develop mathematical models of infectious diseases. These models help researchers to better understand the complex systems of these diseases and provide a framework for making predictions and projections under different scenarios.
The work of the project was further developed in the EBOVAC3 project and in the IMI Ebola+ programme. The European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation by the European Commission which was issued on 1st July 2020 for use of the 2-dose Ebola vaccine Ad26.ZEBOV, MVA-BN-Filo in the European Union in adults and children above one year of age, meaning that the vaccine could be marketed and made available to patients and healthcare professionals throughout the European Economic Area. In April 2021, the vaccine regimen was also granted WHO Prequalification, which facilitates formal registrations of this vaccine regimen in countries at risk of Ebola virus disease outbreaks.
To date, the Janssen Ebola vaccine has vaccinated 250 000 people worldwide with at least one dose.
Achievements & News
Data published in the journal PLOS Medicine demonstrates that the IMI-funded Johnson & Johnson Ebola vaccine regimen was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. ###The data is from a Phase 2 study conducted in Burkina Faso, Cote d’Ivoire, Kenya and Uganda that enrolled 668 healthy adults and 142 adults living with HIV.
The study also confirms that HIV infection (well-controlled via treatment with a highly-active antiretroviral therapy) did not have any apparent influence on the immune responses elicited by the vaccine regimen.
‘These data add to the growing body of evidence supporting the prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect people at risk of Ebola. This is critical to our vision of protecting some of the world’s most vulnerable and underserved people – including people living with HIV – by preventing Ebola outbreaks before they start,’ said Paul Stoffels of Johnson & Johnson.
Find out more
- Read the article in full
In 2014, an Ebola outbreak kicked off in the west African nation of Guinea and quickly spread to Sierra Leone and Liberia, putting other countries in the region on high alert. Epidemiologist and public health expert Professor Nicolas Meda of Burkina Faso played a key role in his country’s response to the epidemic, and participated in the IMI Ebola vaccine project EBOVAC2.### In an interview with the IMI Programme Office, he looks back on the experience and sets out the lessons learnt and actions taken since then to prevent future outbreaks. In the interview, he also highlights the benefits of participating in IMI. ‘In EBOVAC2, it’s pretty much a global collaboration. So this is a challenge and an opportunity to improve our knowledge and our skills on the conduct of vaccine trials,’ he explains. ‘Because as I said, we did a lot of clinical trials, but they were for medicines. This time it was a trial for a vaccine and this experience was important and exciting for the team.’ He also urges countries to boost the capacity of their health systems. ‘At the political level there are measures that every country should put in place to be able to do surveillance well and detect cases early,’ he insists. ‘If you detect early, you have a good chance of limiting the epidemic. But if you don’t have this capacity in the health system to do surveillance and detect early, you will always have big epidemics that spread. So strengthening health systems so that they are capable of detecting and responding rapidly is essential.’
- Read the interview here
- Find out more about EBOVAC2 and the IMI Ebola+ programme
IMI Ebola project EBOVAC2 has launched a campaign in France to recruit around 300 volunteers for a trial Ebola vaccine regimen. The goal of this study is to assess the safety and efficacy of a novel prime boost preventive regimen against Ebola virus disease.### The vaccine regimen under investigation has two parts – a ‘prime’ vaccine to stimulate the immune system and a ‘boost’ vaccine to strengthen and extend the immune response. Additional volunteers are being recruited in the UK and in Africa. ‘Participants in this trial cannot become infected with the Ebola virus,' said EBOVAC2 project coordinator Rodolphe Thiébaut of INSERM. ‘Only synthetic proteins or parts of proteins are used in the various vaccines being tested. They cannot in any way cause infection. This is based on the same principle as many existing vaccines for infectious diseases.’
- Read the INSERM press release on EBOVAC2.
Participants
Show participants on mapEFPIA companies
- Janssen Vaccines & Prevention BV, Leiden, Netherlands
Universities, research organisations, public bodies, non-profit groups
- Centre Muraz, Bobo-Dioulasso, Burkina Faso
- Institut National De La Sante Et De La Recherche Medicale, Paris, France
- London School Of Hygiene And Tropical Medicine Royal Charter, London, United Kingdom
- University of Oxford, Oxford, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Inserm Transfert SA, Paris, France
Third parties
- Chu Hopitaux De Bordeaux, Talence, France
- Universite De Bordeaux, Bordeaux, France
- Universite Paris Xii Val De Marne, Creteil, France
| Participants | |
|---|---|
| Name | EU funding in € |
| Centre Muraz | 3 782 783 |
| Inserm Transfert SA | 427 090 |
| Institut National De La Sante Et De La Recherche Medicale | 15 057 161 |
| London School Of Hygiene And Tropical Medicine Royal Charter | 908 453 |
| University of Oxford | 2 041 083 |
| Third parties | |
| Name | Funding in € |
| Chu Hopitaux De Bordeaux | 329 250 |
| Universite De Bordeaux | 120 000 |
| Universite Paris Xii Val De Marne | 125 000 |
| Total Cost | 22 790 820 |