At the height of the Ebola epidemic in 2014, the virus struck thousands of people, with reported cases stretching from West Africa to Europe and the U.S.
According to the most recent data from the CDC, over 14,000 people were infected in Sierra Leone alone—and nearly 4,000 people died in that country.
In January 2015, as the outbreak continued to devastate communities in West Africa, Johnson & Johnson mounted an unprecedented response by launching a series of partnerships with respected research institutions across the globe to help accelerate clinical testing of an Ebola prime-boost vaccine regimen (the sequential administration of vaccines that use different antigen-delivery systems) in development at the Janssen Pharmaceutical Companies.
Defying all conventional R&D timelines, by the end of 2015, Phase 1, 2 and 3 clinical studies of the vaccine regimen were in motion across three continents, including countries like Sierra Leone.
Although the Ebola crisis has now come to an end, Johnson & Johnson remains fully committed to its vaccine development program, so the world can be better prepared should another outbreak occur.
Two people, in particular, played a pivotal role in getting the clinical trials off the ground: Macaya Douoguih, Director of Clinical Development at Johnson & Johnson, and Tine de Marez, Project Management Office Leader, Global Public Health, who has been spearheading the study in Sierra Leone (EBOVAC-Salone).
So we sat down with Douoguih and de Marez to hear more about their work over the past year—and where the company stands with the Ebola vaccine regimen today.
How did you get involved with this project?
Douoguih (shown right): “I saw the announcement that Johnson & Johnson was ramping up its Ebola effort, and I thought, I need to volunteer to help with this. Within 24 hours of offering my time, I got a response that the company was interested in my getting involved. And after about a week, everything was set, and my boss said, ‘OK, run with it!’ ”
What was it like to get the program up and running?
Douoguih: “We got the opportunity to apply for funding in support of the program from Europe’s Innovative Medicines Initiative. The process normally takes six months because it’s a large application with a lot of different moving pieces to pull together. But we only had three weeks to get our submission in.
So we quickly met with a group of potential partners, including the London School of Hygiene & Tropical Medicine, the University of Oxford and the French research agency Inserm. Many of us, including me, didn’t sleep for days in order to get it done. But we made the deadline—and received grants worth about $110 million.
This was a real boost to the program because it brought together teams of people and the resources needed to deliver on many of the studies we wanted to do. It has been an important part of our success so far.”
How did you get 10 studies off the ground, on three continents, in just one year?
Douoguih: “It’s all about collaboration. Many people at the company, like me, immediately raised their hands to volunteer their time and expertise to the Ebola vaccine effort. We created multiple consortia with many partners in Europe, the United States and Africa to get the job done. We also had the support of regulators and other international health organizations. And we consulted closely with governments in Africa and local communities in Ebola-affected countries to ensure that the program was geared to meet their needs on the front lines. We simply could not have mounted such a massive clinical program in such a short time frame by ourselves—it had to be a huge group effort.”
What did you think when you were first asked to get involved in the Ebola program in Sierra Leone?
De Marez (shown left): “When I got the call in January 2015, I immediately said, ‘Yes, count me in.’ But the head of our Global Public Health organization asked me to discuss it with my family first, pointing out that going to an outbreak country carried some risk. So I started to have second thoughts, thinking about my kids. It’s one thing to expose yourself, but what about my children?
So I educated myself on Ebola, and discussed the trip with my husband, who immediately said, ‘If Johnson & Johnson has something that could help, you really have to do this.’ So I decided to go.”
What did you see when you first arrived in Sierra Leone?
De Marez: “It was a very quiet welcome reception, which is not normally what happens in an African country, where people are typically very friendly. The fear was palpable.
We couldn’t visit the Ebola treatment centers—if we did, we ran the risk of being quarantined when we returned home, and none of us wanted that for our families. But we did drive by the centers. Seeing all the health workers’ boots hanging outside to dry [as part of the decontamination process] has stayed in my mind.”
What challenges did you face as you and the team pulled the study together?
De Marez: “By March we knew we would be moving ahead with the study in Sierra Leone, and that we’d be conducting it in a very rural part of the country called Kambia. There was no electricity, no running water and a limited health care infrastructure.
So together with our partners, we renovated a building to serve as our trial site, and we built a depot where we could safely store investigational vaccine supplies. We also had to find and train health care personnel to help run the study, which was a huge effort because we were in a part of Sierra Leone that had suffered heavy losses of medical staff from Ebola.”
What do you hope to achieve with this research?
Douoguih: “We believe there is a need for a prime-boost Ebola vaccine regimen. Of course, in an emergency outbreak situation, the perception is that a single-dose vaccine is best to protect people quickly. But there’s definitely a role for a two-dose vaccine designed to offer a more durable immune response, particularly now that we are seeing the virus persist in Ebola survivors.”
How did locals in Kambia respond to the study?
De Marez: “They were incredibly supportive, which I think was the result of all the community engagement conducted by our partners. They engaged religious leaders, tribal chiefs, market women and many others to ensure people were informed and empowered.
On the first day of the study in October—known as ‘Vaccine Day’—there was a young man named Idrissa Kamara who was so determined to be the first participant that he arrived hours ahead of the start time. With his consent, we took a picture of him that day and it was subsequently featured on a billboard in Times Square in New York City. When we showed him that, we got a great big smile in return!”
Where are you now with the study?
De Marez: “Stage 1 is complete, and we’re hoping to start Stage 2 as soon as possible. My ultimate hope is that we will be successful in our goal of developing an approved preventive Ebola vaccine. We have to get prepared—now—for the next outbreak, and a vaccine is a critical part of that effort. We owe it to all those who were lost to ensure that this never happens again.”
How do you feel about the work Johnson & Johnson is doing with Ebola?
Douoguih: “I was really impressed by the company’s decision to move ahead with the Ebola vaccine program, because there really is little financial benefit to doing this. Key decisions were made very quickly. Global partnerships were formed with breathtaking speed. To see that we were willing to commit to an important public health issue in this way was very positive for me.”
This article contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding product development. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including the uncertainties of clinical success and obtaining regulatory approvals; the challenges and risks involved in large-scale production of a vaccine; and the uncertainty of the level of demand for the product. The reader is cautioned not to rely on these forward-looking statements and should review the Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, for a further list and description of these risks, uncertainties and other factors. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.