Tag: Clinical research

How can we manufacture the safest possible challenge agents for human infection studies?

Pipettes in a scientific lab
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…)

A week in the life of a Clinical Research Fellow

Dr Francesca Conway takes us through a typical week as a clinical research fellow and how her previous time at Imperial contributed to her developing an interest in a career in clinical academia.

Monday

6am. I’m awakened by the horrifically jolly alarm tone on my phone. It’s still dark, it’s still raining, and it’s still cold. Hedgehogs have the right idea hibernating over winter, I think, as I haul myself out of bed.  Must consider this hibernation proposition in my next supervisor meeting. 1 shower, 1 yoghurt and 3 smoothies later and I’m in the hospital.

Today I have a patient coming to see if she is eligible to be recruited to the clinical trial which forms part of my PhD. Mrs X has travelled from 300 miles away. She greets me with a smile and tells me how pleased she is to be here. I immediately remember why I love my job, and scrap the idea of hibernation. I offer her a coffee, she gratefully accepts and whispers, could I have an extra shot in that? I assume she means coffee. I wonder what time she woke up, but am pretty sure it was before 6am.

I am researching a potential new treatment for Chronic Cbstructive Pulmonary Disease (COPD) for my PhD. Mrs X suffers with COPD, a disease affecting the lungs most commonly caused by smoking. More than 3 million people die from it each year. Targeted Lung Denervation or “TLD”, is a non-surgical procedure where we deliver energy to the airways using a system made by Nuvaira, a US-based company. The idea is that the energy disrupts the nerve supply to the lungs, so the airways relax and open. With initial data looking promising, we hope that this will lead to improvements in health for patients like Mrs X. More information on the Airflow website. (more…)