Ebola+

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

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.

Find out more

• 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.

Find out more

• 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.’

Find out more

• Read the full news story
• IMI Ebola+ programme
• More success stories from IMI's Ebola+ programme

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.

Find out more

• Read IMI’s news story
• Read the Janssen press release

The Rwandan Ministry of Health has launched a programme to vaccinate 200 000 people with the Johnson & Johnson (Janssen) Ebola vaccine regimen. The two-part vaccine regimen was developed with support from IMI’s Ebola+ programme, and studies show that it triggers a long-lasting immune response against the Zaire strain of Ebola.### It will be offered to people aged two and up who live on the border with the Democratic Republic of Congo (DRC), which is currently experiencing the second worst Ebola outbreak in history. Many Rwandans regularly cross the border with the DRC for work, school, or family commitments, and the government hopes the vaccination programme will stop Ebola from impacting its citizens. The DRC started a vaccination programme using the Janssen vaccine in mid November, also with the goal of preventing the spread of the epidemic.

Read more

• The Rwanda Ministry of Health press release
• The Johnson & Johnson press release
• IMI’s Ebola+ programme

An international consortium has started a large-scale clinical trial of an Ebola vaccine regimen in the Democratic Republic of the Congo (DRC), which is currently experiencing the second worst Ebola epidemic in history. The new trial has been designed to prevent the spread of the epidemic beyond the areas that are currently affected, and if possible to gather crucial information about the effectiveness of the vaccine ###to be better prepared to fight Ebola in the future. The vaccine regimen, which is manufactured by the Janssen Pharmaceutical Companies of Johnson & Johnson, is being offered to adults and children aged a year or older in communities near the outbreak who are considered at risk.

A number of organisations have contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme. Specifically, the projects EBOVAC1, EBOVAC2 and EBOVAC3 supported earlier clinical trials of the vaccine regimen, while EBOMAN supported its manufacture. Finally, the EBODAC project successfully facilitated the engagement of local communities, something it is also poised to do in this latest trial in the DRC.

Find out more

• IMI’s news story
• Medecins Sans Frontiers news story on the first vaccinations
• IMI Ebola+ programme

Throughout October, we spotlighted some of the results of our Ebola-related research projects in our newsroom. ###Most of IMI’s 12 Ebola projects were launched in 2014-2015 when an unprecedented Ebola outbreak ravaged parts of western Africa. The epidemic killed thousands of people and terrified communities, and took two and a half years to be brought under control.

Since then, IMI researchers have been involved in testing the safety, efficacy and durability of two candidate vaccines that show the most promise in preventing infection. Both vaccines, rVSV∆G-ZEBOV-GP and the ‘prime boost’ vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) are currently undergoing clinical trials. IMI-backed researchers have also come up with new rapid diagnostic tests for Ebola. Other projects focused on reducing the onerous conditions for vaccine storage and transport, preparing for large-scale manufacture of vaccines and even running community engagement campaigns for the success of clinical trials.

Read the articles:

• Focus on Ebola
• Ebola can now be detected in 15 minutes. Here’s how the diagnostics tests work
• How do you prepare for a pandemic? – editorial by Pierre Meulien, IMI Executive Director
• As Ebola rages in the DRC, the world is closer than ever to the first licensed vaccine
• Project to team up with African manufacturer to make diagnostic tests

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’s Mofina project developed a portable device which can test for deadly Ebola in 75 minutes or less, eliminating the need to take suspected Ebola patients to treatment centres far away of their communities. In an interview with the IMI Programme office, the project’s coordinator, Edmund Newman of Public Health England, explains how Mofina’s success will save lives, and help contain future outbreaks. ###‘We now have a portable platform for testing all of the different types of Ebola virus that can run on a battery pack for up to 8 hours,' said Newman. 'It is a mobile platform that will give you a test result for all different types of Ebola within just over an hour, 75 minutes. It doesn’t require a big lab set up in the middle of the field somewhere. It is literally a finger prick of blood into an automated machine that is not much bigger than a shoe box and so it can easily be carried around and taken to the patient for testing. The device has been fully validated and verified for all the strains of Ebola that it tests for. It is commercially available and ready for the next outbreak.'

Read the full interview

When it comes to Ebola, diagnosing infected patients quickly and accurately is key to controlling the spread of the virus. However, this can currently only be done in relatively sophisticated laboratory settings, which may be many miles from affected areas.### To tackle this problem, IMI’s EbolaMoDRAD project is developing and validating new diagnostic tests for Ebola that can be carried out wherever patients are located, quickly and safely, without the need for highly technical laboratory equipment or training. The project researchers have investigated various techniques for detecting the Ebola virus infection in blood samples, including testing for the presence of the virus itself and measuring molecules that reflect the immune response to viral infection.

The most promising method is known as isothermal amplification, which detects the genetic material inside the virus. Unlike other gene detection methods that require samples to be taken through multiple cycles of heating and cooling over several hours, isothermal amplification is carried out at a constant temperature of around 60⁰C and takes less than an hour. The team is now validating the test with samples collected from infected patients in West Africa, ensuring that it is accurate, sensitive and reliable enough to be used in the field. As well as detecting Ebola, the isothermal amplification technique can also be adapted to diagnose other similar viruses, such as the Marburg virus. ‘If there is an outbreak of a new disease we can add that to the test and we can detect several viruses with just one assay,’ says project coordinator Ali Mirazimi of Sweden’s Public Health Agency. ‘It is challenging but if we are ready for the next outbreak we can make a difference.’

• Read the full story

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.

Earlier this summer, researchers announced in The Lancet  that an Ebola vaccine developed with Merck had shown 100% effectiveness in a Phase III clinical trial of over 7 000 people in Guinea. This is one of the potential vaccines being developed for the disease, and researchers say that work must continue.###

IMI’s VSV-EBOVAC project is studying in detail the signatures of immune responses elicited in humans by the VSV-ZEBOV vaccine using cutting-edge technologies combining in-depth human immune, transcriptomics and metabolomics profiling in relation to safety and immunogenicity.

One of the outstanding questions – which VSV-EBOVAC hopes to answer once enough time has elapsed since the Phase I trial, started in November 2014 – is how long the immunisation remains effective. 

Many believe that the Merck vaccine should be used to protect those at high risk in areas still affected by Ebola. However, it may take months for approval by authorities.

The timing means that these vaccines under development are unlikely to have much of an impact on the current epidemic. However, these vaccines have been developed at unprecedented speed, and the work being done lays down techniques that could be used in similar fast-moving epidemics.

• To find out more, read the Horizon Magazine article

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

EBOVAC trial in Sierra Leone starts; boosts local health infrastructure
A clinical trial of an investigational Ebola vaccine regimen is now underway in Kambia, Sierra Leone thanks to the IMI projects EBOVAC1, EBODAC and EBOMAN. ###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.
(October 2015)

First IMI Ebola projects get underway
The Innovative Medicines Initiative (IMI) is launching the first eight projects of its Ebola+ programme, to accelerate all aspects of vaccine development and manufacturing as well as deployment and compliance with vaccine regimens and diagnostics. The eight projects were selected from proposals submitted under IMI’s first Ebola+ Call for proposals, which was launched in November 2014. ###The projects will have a total budget of €215 million, part of which comes from Horizon 2020, the EU’s research and innovation programme, and part of which comes in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects. Of the eight projects, three will focus on the development of Ebola vaccines; one will work on scaling up vaccine manufacture; one will develop strategies to promote compliance with vaccine regimens; and three aim to develop rapid diagnostic tests that can be used at the point of care and at major infrastructures like airports.
-Read the IMI press release
(January 2015)

Innovative Medicines Initiative launches Ebola+ programme
The Innovative Medicines Initiative (IMI) is launching a multi-million euro programme on Ebola and related diseases such as Marburg haemorrhagic fever. Dubbed Ebola+, the comprehensive programme will see pharmaceutical companies collaborating with each other and with experts from universities, small biotech companies, regulators, and others to tackle a broad range of challenges in Ebola research. ### The first Call for proposals in the programme has a total budget of €280 million and will result in projects addressing the development, manufacture, transport, and storage of vaccines; ensuring compliance with vaccine regimens; and the development of rapid diagnostic tests. The first projects are expected to begin in early 2015, and the hope is that they will deliver results that will contribute to tackling both the current and future outbreaks.
- Read the IMI press release
(November 2014)