There are currently no licensed vaccines for Ebola. However, there are a number of vaccine candidates in development. EBOVAC 1 and 2 are two of three projects in the IMI Ebola+ programme that are generating the data needed to assess the safety and immunogenicity of different vaccine candidates and the level and duration of protection they actually offer against the disease.
Between them, the two EBOVAC projects are assessing, through clinical trials in Europe and Africa, the safety and tolerability of the ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In a prime-boost vaccine regimen, patients are first given a dose to prime the immune system, and then a boost dose which is intended to enhance the immune response over time.
Phase I trials will be carried out by the EBOVAC1 project. These trials will gather preliminary information on the safety and tolerability of the vaccine regimen. The immune response generated by the regimen will also be evaluated longer term.
Subject to review of the preliminary Phase I data, the Phase II and III trials, will be carried out in parallel by the EBOVAC2 and EBOVAC1 projects respectively to speed up the clinical development of the vaccine regimen. In these trials, larger groups of people will receive the vaccine regimen, allowing the projects to gather further information on the regimen’s safety and immunogenicity, including in specific groups such as children and the elderly, and to assess its efficacy against Ebola virus.
A part of the Ebola+ Programme
The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, and transport, as well as diagnostics. The programme complements work being carried out with the support of other funding bodies. In addition to Ebola, the programme will also address related diseases, such as Marburg.
About Ebola and related diseases
Ebola virus disease (EVD), previously known as Ebola haemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus strains. The virus spreads in the human population through direct human-to-human contact with the bodily fluids of infected patients who are showing symptoms. It has an incubation period of 2-21 days, and it usually begins with flu-like symptoms, but rapidly progresses to multiple organ failure and blood-clotting abnormalities which manifest as internal and external haemorrhages (bleeding). It is fatal in between 25% and 90% of cases. There is currently no licensed treatment against EVD, and the development of treatments and preventive measures such as vaccines is hampered by challenges including manufacturing-related hurdles, the stability of vaccines during transport and storage, vaccine deployment, and the time taken to diagnose cases of EVD.
Ebola is a member of the filovirus family of viruses, which also includes Marburg virus. Like Ebola, Marburg causes cause severe, often fatal haemorrhagic fever in humans and other primates (monkeys, gorillas and chimpanzees), and like Ebola, it is transmitted directly from one person to another. (In contrast, other viruses that cause haemorrhagic fevers are spread via intermediate hosts - for example, dengue fever is transmitted by mosquitoes.) There is no specific treatment or vaccine against Marburg haemorrhagic fever.
The 2014-15 Ebola epidemic was unprecedented in its scale and geographical distribution. By the middle of 2015, World Health Organization (WHO) statistics recorded over 27 000 cases and 11 000 deaths from the disease, most of them in Guinea, Liberia, and Sierra Leone. The epidemic highlighted the need for research into better vaccines, diagnostics and treatments to stop future epidemics in their tracks.
Achievements & News
European marketing authorisation, WHO prequalification and an expert-backed recommendation mean the IMI-funded Johnson & Johnson Ebola vaccine regimen is closer to widespread uptake to prevent future outbreaks. ### The complete study results of the IMI-funded EBOVAC-Salone study were recently published in the Lancet, showing that the vaccine regimen is safe, well-tolerated and produces a strong immune response in people over the age of one, the first evaluation of the vaccine regimen in children.
The study findings had already contributed to the approval and marketing authorisation of the J&J Ebola vaccine regimen in July 2020 by the European Commission, for use in both children and adults, and to WHO prequalification in April 2021, which is a step towards formally registering the vaccine regimen in countries at risk of Ebola virus disease outbreaks.
In another important milestone, the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization made a recommendation in support of using the regimen during outbreaks for people at risk of Ebola exposure and preventively for first responders. Focus now shifts to securing national registrations for the vaccine in Ebola-affected countries in Africa. Discussions are also ongoing with the US Food and Drug Administration regarding the approval of the vaccine regimen in the US.
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- Read the article in full
Data on the safety and immunogenicity of the technology behind the Johnson & Johnson COVID-19 vaccine was gathered during IMI-supported clinical studies into the company’s Ebola vaccine.###
The new COVID-19 vaccine is based on the company’s unique and proprietary AdVac® technology. Through the EBOVAC projects, IMI funded Phase 1, 2 and 3 clinical studies that generated data on the safety of the AdVac® vaccine platform, providing evidence upon which the European regulator based its decision on the COVID-19 vaccine. The European Commission granted conditional marketing authorisation for the single-dose COVID-19 vaccine on 11 March.
‘The EBOVAC studies have made an important contribution to our global safety database for the platform technology,’ said a Johnson & Johnson representative. ‘Studies specifically supported by EBOVAC played an important role supporting our successful licensure application for the Ebola vaccine with the European Medicines Agency. Additionally, they gave the company confidence to use the AdVac® platform to initiate the development of COVID-19 vaccine.'
Like the Ebola vaccine regimen (which received marketing authorisation last summer), the Johnson & Johnson COVID-19 vaccine is compatible with standard storage and distribution channels, which makes it easy to transport to and deploy in remote areas.
The company is also using the AdVac® platform to develop preventive vaccine candidates for HIV, Zika and RSV (respiratory syncytial virus). Meanwhile IMI projects are continuing to support Ebola vaccination programmes in Africa.
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- Read the news article in full
The European Commission has officially granted market authorisation for an IMI-supported Ebola vaccine regimen, which represents a vital tool in the fight against the deadly disease. The marketing authorisation is for Janssen, a Johnson & Johnson company, for its two-dose ‘prime-boost’ Ebola vaccine regimen. ###It is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and up. As such, it can be used to support preventive vaccination in countries most at risk of outbreaks. A number of organisations contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme.
‘IMI is immensely proud to have contributed to the development of this much-needed Ebola vaccine regimen. Through our Ebola+ projects, we brought together some of the world’s leading experts in Ebola from universities, the pharmaceutical industry, small companies, and the charity sector in Europe, Africa and the US,’ said IMI Executive Director Pierre Meulien. ‘By working together, often in challenging circumstances, they were able to significantly advance the development of this Ebola vaccine regimen and so pave the way for today’s decision.’
‘The investment from the EU's research programme Horizon 2020 into several Innovative Medicines Initiative Ebola projects is now bearing fruit,’ said Mariya Gabriel, European Commissioner in charge of Research. ‘This demonstrates, yet again, the power of collaboration and European R&I leadership to tackle global health threats.’
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Johnson & Johnson has announced that its Janssen Pharmaceutical Companies received a positive opinion from the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen for the prevention of the Ebola virus disease caused by the Zaire ebolavirus.###
The two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo) is designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers and Biosafety Level 4 (BSL-4) lab workers.
To date, approximately 60 000 people have been vaccinated with the vaccine regimen in clinical studies and vaccination initiatives. Studies indicate that it is well tolerated, inducing robust and durable immune responses to the Zaire ebolavirus.
A number of organisations contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme.
Janssen is collaborating with the World Health Organization (WHO) on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries; European Commission approval of this regimen may help accelerate this process. The recent Ebola outbreak which started in the Democratic Republic of the Congo (DRC) in 2018 was the second worst on record. It has caused more than 3 000 cases and over 2 000 deaths.
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The immune response triggered by Johnson & Johnson’s two-part ‘prime boost’ Ebola vaccine regimen appears to last at least one year, according to a new study published in the Journal of the American Medical Association (JAMA). The research was funded in part by IMI’s EBOVAC1 project. The west African Ebola outbreak, which infected 28 000 people and killed over 11 000, ###highlighted the urgent need for a vaccine against the disease. The vaccine regimen is being developed by Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Bavarian Nordic. It consists of an initial vaccine dose to prime the immune system, followed by a boost dose of another vaccine which is intended to enhance the immune response over time. Trials of the regimen are taking place in Europe, Africa, and the US. This latest study focuses on a Phase I trial in Oxford, UK, in which 75 healthy volunteers received the vaccine regimen. Of the 64 people who attended the one-year follow-up, all had high levels in their blood of Ebola virus glycoprotein-specific antibodies; these antibodies appear to play an important role in immunity to the disease. ‘The world needs a vaccine to help prevent or mitigate future Ebola outbreaks, and ideally it should provide sustained protection for at-risk populations,’ said Johnson & Johnson Chief Scientific Officer Paul Stoffels. ‘We are committed to helping the global community finish the job of finding an Ebola vaccine. Together with our consortium partners the London School of Hygiene & Tropical Medicine, University of Oxford, and Inserm, we are grateful for the ongoing support of Europe’s Innovative Medicines Initiative (IMI), BARDA and NIH.’
- Read Johnson & Johnson’s press release on the paper
Data from an early stage clinical trial of a novel Ebola vaccine regimen show that it produces a long-lasting immune response and is well tolerated, with minimal side effects. The study, supported in part by IMI through the Ebola+ project EBOVAC1, is published in the Journal of the American Medical Association (JAMA).### In the trial, healthy volunteers in the UK received a two-part ‘prime boost’ regimen comprising an initial vaccine dose to ‘prime’ the immune system and a subsequent dose of a different vaccine to ‘boost’ the immune response. Significantly, eight months after immunisation, 100% of those vaccinated still had Ebola-specific antibodies. This long-term protection is important. ‘Recent evidence highlighting the persistence of the Ebola virus in bodily fluids, and the potential for sexual transmission from Ebola survivors, reinforce the importance of finding a robust and durable vaccine for this disease,’ explains Matthew Snape of the Oxford Vaccine Group and the study’s lead author. In total, 10 clinical studies on this regimen are taking place in Europe, Africa and the US. The west African Ebola outbreak has infected over 28 600 people and killed more than 11 300. Flare-ups continue to occur in the region due to the persistence of the virus among survivors.
Even in the short term, the benefits to the local community of the ‘EBOVAC-Salone’ trial are immense; new facilities had to be built to run the study, including the first emergency room at the local district hospital, and a vaccine storage facility. In addition, the project provides both jobs and training for local healthcare workers, who will also gain valuable experience by working on the trial. In the longer term, the community may also benefit if the vaccine regimen is approved.
Sierra Leone was at the epicentre of the Ebola outbreak, with 14 000 cases and 4 000 deaths, including many healthcare workers. The vaccine regimen under investigation is a ‘prime-boost’ regimen, in which two doses are given several weeks apart. The first dose ‘primes’ the immune system, while the second ‘boost’ reinforces its effects with the goal of potentially strengthening and optimising the duration of the immunity. The study is notable in that it will evaluate the vaccine regimen’s safety and immune response within the general population of Sierra Leone, including vulnerable groups such as adolescents and children. The vaccine regimen is also in trials in other parts of Africa, Europe and the US.
The EBOVAC-Salone trial is working closely with the IMI project EBODAC, which aims to ensure the prime-boost vaccine regimen is well accepted and successfully deployed. It is doing this by informing local engagement strategies, designing graphical communication aids, deploying technological solutions to increase compliance and uniquely identifying trial participants.
A clinical trial of an Ebola vaccine regimen run through the IMI project EBOVAC1 has started in Kenya and Uganda. The trials are Phase I studies designed to evaluate the safety of the vaccine regimen and evaluate the long-term immune response to a regimen developed at the Janssen Pharmaceutical Companies of Johnson and Johnson.### In each of the Phase I trial sites, 36 healthy adult volunteers receive either a placebo, or a two-part ‘prime-boost’ vaccine regimen, comprising an initial dose to prime the immune system and a ‘boost’ to enhance the immune response in the longer term. Similar studies are already underway in the UK and US and further studies in Africa, including in Sierra Leone, are anticipated to receive approval soon. The EBOVAC1 project is part of IMI’s wider Ebola+ programme, which currently covers vaccines and diagnostics and it is hoped will deliver results that will contribute to efforts to tackle both the current and future outbreaks.
According to WHO reports, as of mid-April there had been over 25 000 confirmed, probable, and suspected cases of Ebola in the current outbreak and over 10 000 deaths, most of them in Guinea, Liberia, and Sierra Leone
ParticipantsShow participants on map
- Janssen Vaccines & Prevention BV, Leiden, Netherlands
Universities, research organisations, public bodies, non-profit groups
- 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 Sierra Leone, Freetown, Sierra Leone
- University of Oxford, Oxford, United Kingdom
- Chu Hopitaux De Bordeaux, Talence, France
- Universite De Bordeaux, Bordeaux, France
|Name||IHI funding in €|
|Institut National De La Sante Et De La Recherche Medicale||573 723|
|London School Of Hygiene And Tropical Medicine Royal Charter||47 208 318|
|University of Oxford||1 376 981|
|University Of Sierra Leone||9 097 864|
|Name||Funding in €|
|Chu Hopitaux De Bordeaux||35 000|
|Universite De Bordeaux||45 000|
|Total Cost||58 336 886|