Dr Emma Smith—HIC-Vac Network Manager—explains how specific guidelines for the provenance and manufacture of challenge agents could make human infection studies even safer.
Human infection studies, also known as human challenge studies, are clinical trials where volunteers are intentionally given a carefully considered dose of a pathogen—known as the challenge agent. These models can be used to study host-pathogen interactions and disease progression; identify and test the efficacy of promising vaccines and drugs in development; or be used as proof-of-concept studies for testing novel medications. In this controlled environment it is possible to study infections in ways that aren’t possible in traditional field studies.
One of the first steps towards establishing a challenge study is the selection, isolation, development and production of the challenge agent. However, unlike medicines, the regulation of challenge agent manufacture varies internationally; an area that the research community has identified as a potential weakness in the field. Although human challenge studies have an excellent safety record—a recent literature review identified just 24 Serious Adverse Events (SAE) and zero deaths or cases of permanent damage among 15,046 participants in 308 studies spanning 1980 to 2021— the lack of specific guidelines for the provenance and manufacture of challenge agents warrants attention.
HIC-Vac—an Imperial-led international network of researchers who are developing human infection challenge studies—has been working with the global charitable foundation Wellcome and the company hVIVO to address this unmet need. Our purpose was to promote volunteer safety whilst maximizing access to challenge agents and challenge models globally. (more…)
Every time I exercise, take public transport, do my weekly food shop, socialise with those close to me, I’ve been trying to quash this invisible shield that part of my brain believes might be there, shrugging off any potential encounters with the SARS-CoV-2 virus.
I didn’t enter this trial so that I’d get a free pass to behave irresponsibly in the midst of a pandemic, which is frighteningly rearing its ugly head again in my home country. I always knew that immunity was never a certainty, having never been tested in human beings before. I was more confident that it wasn’t a dangerous thing for me to do, and certain that it was a good thing to do.
And by participating, I have certainly helped to prove both of these latter points. I’ve had two shots of the vaccine, which works by instructing my cells to make fragments of the coronavirus, thereby prompting my immune system to react and, hopefully, keep a protective memory of the threat. I’ve had no side effects at all; not even a sore arm. The devil on my shoulder sort of wished for even a little redness where the needle went in, that I could wear proudly as a mark of my contribution to research. (more…)
Justine is taking part in Imperial’s COVID-19 vaccine clinical trial – here she shares her experience of receiving the first dose.
It’s a strange feeling that as I write this, the cells in my arm are reading a message that scientists planted there just hours ago.
That message – a strip of genetic code – contains the recipe for making part of the virus that causes COVID-19, SARS-CoV-2. This is the ‘spike’ protein that the virus uses to lock on to cells and invade them. The hope is that by telling my cells to churn out this molecule, my immune system will launch an effective and lasting response that could make me immune to the coronavirus.
That’s the theory, anyway; we won’t know whether this experimental vaccine works until scientists have carried out rigorous clinical studies and gathered enough data to be confident of how safe and effective it is. And today I was part of that clinical research.
I’m one of 120 people who have so far been selected to take part in one of the earliest phases of a clinical trial that’s testing Imperial’s newly-developed coronavirus vaccine. As soon as I spotted that the trial was recruiting participants, I immediately slotted my details into the online form to express my interest in joining, and eagerly awaited a response. (more…)
Nora Schmit was shortlisted for the MRC Max Perutz Science Writing Award 2019 for the following article on her PhD research on predicting the impact of treatment for hepatitis B infection on preventing liver cancer in The Gambia.
What’s the first thing that comes to your mind when you think of cancer prevention? Maybe you’re thinking of not smoking or maintaining a healthy weight – great strategies to reduce your chance of getting cancer.
But did you know that the hepatitis B vaccine, introduced in the 1980s, has long protected children in many parts of the world from developing one of the most common and deadliest cancers later in life?
Although most people have no symptoms when they first become infected, the hepatitis B virus is the leading cause of liver cancer worldwide. Large-scale efforts to tackle the virus using vaccination have been hugely successful in preventing infections in children. Despite this remarkable achievement, hepatitis B infections are still very common and nearly a million people die from its consequences every year. With around 6% of all people living in Africa currently infected, the death toll there is expected to rise even further.
But while a liver cancer diagnosis is nearly always fatal, treating the infection is possible with the same drugs that work against HIV. So why do so few people receive these drugs, when over half of all liver cancer deaths globally are preventable? (more…)
Dr Malick Gibani unravels the mystery behind the role of typhoid toxin in causing typhoid fever – a disease that affects around 11 million people each year globally.
Salmonella Typhi is a fascinatingly complex bacterium. Whilst there are more than 2000 different (sero)types of Salmonella, there’s something special about Salmonella Typhi that sets it apart from the non-typhoidal Salmonella serovars. It causes different symptoms, the means of spread are different and the host it infects is different – specifically, Salmonella Typhi only causes disease in humans.
Understanding the mechanisms of how bacteria can cause disease is profoundly important for vaccine development. The Vi-antigen that forms the major component of injectable typhoid vaccines seems to have a key role in making the bacteria more virulent (hence the name). Vi-based vaccines have proven to be highly effective tools to prevent typhoid. (more…)
When outbreaks emerge, speeding up vaccine development could be the difference between life and death. In this post, Dr Zoltán Kis provides an insight into how Imperial’s chemical engineers are making speedy vaccines a reality.
The worst Ebola epidemic in history swept across West Africa between 2014 to 2016, claiming 11,300 lives. This major outbreak was closely followed by the 2015-2016 Zika epidemic in Latin America. Preventing future epidemics is more important than ever and developing new vaccines are an essential weapon in fighting disease outbreaks. However, with the average vaccine development lasting 10 years, this is not comparable to the speed and frequency of outbreaks which can cause calamity in a matter of months. (more…)
As the Imperial Network for Vaccine Research launches, Dr Chris Chiu tells us why he’s in pursuit of a collaborative approach for developing new vaccines.
Vaccines have been very much in the public eye for a while now, with strong feelings expressed particularly on the side of those who are suspicious of them. As health and scientific professionals, we often try to provide a carefully balanced view but, in this case, it is vitally important that we remember and highlight the massive amount of good that vaccines have done for human health. Once devastating diseases such as smallpox and polio are now gone or almost gone. Vaccines have truly been one of the great triumphs of modern medicine. (more…)