Fieldset
Subject 001016: The Vaccine Trial

Disclaimer: While Nick works for MSF in the UK, he is taking part in this vaccine trial as an individual - not as an MSF member of staff.

Disclaimer: While Nick works for MSF in the UK, he is taking part in this vaccine trial as an individual - not as an MSF member of staff.

It’s odd to think I currently have a small bit of one of the world’s deadliest viruses coursing through my veins. It’s a virus so lethal that up to 90 percent of those who catch it can die. At the moment, it’s rampaging through West Africa – in Liberia, Sierra Leone and Guinea – tearing thousands of families apart in its wake. And it’s in my blood. Thankfully, despite having a part of the virus, I don’t stand a chance of catching it. I’ve been given an Ebola vaccination, the first of its kind. 

I’ve just returned from the Jenner Institute at Oxford University where the first ever Ebola vaccination clinical trial is taking place. Sixty of us willing volunteers are taking part. The aim: to test the safety of the vaccine before it’s taken to the field.

Friends and family have said I must be mad to want to take part, but I struggle to see the issue. As I write, 10 of my MSF colleagues have died from the virus, along with hundreds of other healthcare workers in West Africa. To me, having a sore arm and potentially feeling a bit fluey is a very small sacrifice to make if it means lives will be saved in the future, and that my colleagues can work without putting themselves at even greater risk.

Now, this blog is usually a place for MSF field staff to write about their daily lives, the patients they meet and the hospitals they help to run. People like Martin and Patricia, who have been or are out in West Africa at the moment. However, the lovely Clare Storry, who runs this marvelous site, has allowed me to try and tell the story of how the Ebola battle is being fought away from the front lines.

The Ebola vaccine

The vaccine I’ve been given is called ChAd3, which uses a single benign Ebola virus protein (one seventh of the whole virus) to generate an immune response. It’s carried into my body by a vector, in this case a chimpanzee adenovirus – or, a common cold. I’m deliberately being given a virus as it gets inside cells and produces a particular type of immunity. It’s specifically a chimp virus as we are often immune to human common colds, meaning the vaccine wouldn’t have a chance to begin to work. You’re essentially tricking your immune system into thinking it has an infection.  

The vaccine itself has an unexpected history. It’s the product of a decade of research by a collaborative group including the US National Institute of Allergy and Infectious Diseases and an Italian biotechnology company, Okairos, recently bought by GlaxoSmithKline. After the anthrax attack in Florida in 2001, the US government was alerted to the threat of bioterror, with Ebola seen as a potential threat. Research was soon ramped up to find a vaccine for the disease. 

Prior to being given the vaccine, I had a few questions that I felt needed answering. I went to speak to Professor Adrian Hill, the Director of the Jenner Institute, who is leading the trial.

“The big question is will the immune responses that we generate with the vaccine be strong enough? That’s always a question with new vaccines,” says Professor Hill. The volunteers in this trial have been put into three groups, with each group receiving either a low, medium or high dose of the vaccine. I’m in the high dose group. One thing that puzzled me was the speed at which this vaccination could potentially be rolled out to the field. I’ve heard reports that it could be deployed before the trial ends – I'm taking part until March.

“The clinical trial team will have early results in immunology by late October, early November, giving them guidance as to whether the vaccine can be used in Liberia, Sierra Leone and Guinea,” explains Professor Hill. “We keep following people because we want to document safety as much as possible. With any vaccine, objective number one is to determine if it’s safe. If it’s not safe, you can forget about it.”

With any new vaccine, there’s also the question of manufacturing. It can take months to produce a vaccine before the safety trials even begin. “The big advantage here was there was some vaccine already made [thanks to the research conducted since 2001]. There was enough to do some trials, but not enough to roll out to healthcare workers, who are our target population. So 15-20,000 doses are being made. The manufacturers are really speeding things up as much as they can."  

Blood taken before the vaccinePhoto: Nick Owen

Blood taken before the vaccine was given. I have to go back to the Jenner Institute eight times over the next six months to have my blood tested. These bloods were taken to give a 'baseline' reading.

A 'prevent all' Ebola vaccine?

Being the scientific dolt that I am, I wasn’t sure if this vaccine would work for all strains of Ebola. There are five different strains of the virus: Bundibugyo, Ivory Coast, Reston, Sudan and Zaire, named after their places of origin. As it turns out, the reason we might have a working vaccine so soon is all down to a long series of coincidences.

“This particular vaccine is the Zaire strain. It just so happened that the Zaire strain is very similar to the outbreak variant, which is now being called the ‘Guinea’ variant. At a sequence level it’s 97 percent identical, and more importantly, immunologically it looks cross reactive so almost certainly this Zaire strain vaccine will work for the Guinea virus. However, it almost certainly won’t work for the Sudan strain of Ebola, which is only 60 percent identical.

“When the researchers in America and their collaborators in Italy designed an Ebola vaccine some years ago, they were targeting one that would prevent any strain of Ebola. They had to cover as many strains as they thought were reasonably doable and they made two; they made Sudan and Zaire.”

Thermostable?

From MSF’s perspective, one of the most important characteristics of a vaccine is that it’s thermostable, meaning that the vaccine doesn't need to be kept in a ‘cold-chain’ from production to delivery. Unfortunately, with the Ebola vaccine this won’t be the case. It needs to be kept below freezing until it's given.

“Frankly, there isn’t time,” implores Professor Hill. To make the existing vaccine thermostable would require a change in the manufacturing process which could mean months, if not years, of delays before the vaccine could be rolled out on a large scale. It can be done, just not right now. 

“Firstly, you develop a small amount in a process that works in litres,” he explains of the manufacturing method. “It then works in hundreds of litres, to thousands of litres and that takes time to scale up from small to large and ensure that the manufacturing quality is as good as it was at a small scale.”

Although my friends across MSF will be disappointed to hear this, it does make sense. “Realistically, we don’t have time to change the process,” says Hill. “We have to use the process that we have and do it more often in more places, and make it more efficient. It’s not very cost effective but that’s all we can do starting from where we are.”

The good news, however, is that this vaccine is not going to cost patients or the people delivering the vaccine. The vaccine in production at the moment is funded by an award from three UK organisations: the Medical Research Council, the Wellcome Trust and the Department for International Development. The research that has gone into the disease and the results from the trial will all be open source, too.

EBL-001016 trial participant

No name! This is how I'll be known to those conducting the trial from now on. For the first 28-days after the vaccine is given I have to keep an electronic diary recording any symptoms that I may experience. 

Other outbreak pathogens

The final question I had for Professor Hill was a personal one: how has it made him feel to be a part of such a groundbreaking trial?

“I’m excited,” he says emphatically. “We’re developing a vaccine that might be used by the end of the year which is fantastically invigorating for the whole team.”

“Hopefully this will bring more money into the field and more attention to outbreak pathogens. Remember, there’s not just Ebola out there. There’s Marburg, Lassa fever, Rift Valley fever, MERS. There are a lot of outbreak pathogens we don’t have vaccines for, so if that could change that would be fantastic.”

So what needs to change?

“We need stockpiles of these vaccines. If, instead of having a vaccine made but not tested for Ebola six months ago, we had a stockpile of vaccines that are shown to be safe and tested in small clinical trials sitting in the relevant regions, maybe Central or West Africa, available to be used as soon as an outbreak happened, you might well have been in a position to stop the outbreak.

“You can’t guarantee that but it would have been worth trying. So I think that’s where we should be next time. Even if this vaccine cannot be used quickly enough to stop the current outbreak, then for next time, we should be better prepared.”   

I’m hoping that my taking part in this trial does just that.