Open Orphan PLC (LON:ORPH ) Chief Executive Officer Cathal Friel caught up with DirectorsTalk for an exclusive interview to discuss the world’s first human coronavirus challenge study model. Q1: We’ve just seen that you’ve begun the development of the world’s first commercial human coronavirus challenge study model. What can […]
Open Orphan plc (LON:ORPH) in a string of positive news releases catch up with DirectorsTalk to discuss two human study challenges. Executive Chairman Cathal Friel joins DirectorsTalk to discuss the commencement of development of world’s first commercial human coronavirus challenge study model. Cathal provides us with more details on […]
Firms across the world are looking for fast-track approval for trials as Covid-19 cases are mounting Some experts suggest challenge studies on animals, and even humans, for faster trials
Summary Controlled human infection trials, whereby a small group of healthy participants is deliberately exposed to a pathogen under controlled circumstances, can provide preliminary data for vaccine efficacy and for the selection of the most promising candidate vaccines for field trials. Because of the potential harm to participants through […]
No amount of observations of white swans can allow the inference that all swans are white, but the observation of a single black swan is sufficient to refute that conclusion.
An example of the Controlled Human Infection Model (CHIM)
This text is adapted from Lambkin-Williams et al. 2018, the original manuscript is open source and available here along with the citation details.
Since Sir Edward Jenner performed the first documented HVC study with smallpox on the 14th of May 1796 the usefulness of such studies has been apparent. More than a century later, Sir Christopher Andrews returned from the US in 1931 he had observed the use of chimpanzees in the study of influenza. The funding for similar work in the UK was insufficient, and therefore Sir Christopher enrolled students from St Bartholomew’s Hospital in London. He explained the next best thing would be a “Bart’s” student as “they were cheaper than chimpanzees”. Over 100 students immediately enrolled, but continued their studies and were not isolated in the same way the chimpanzees had been in the USA. Unfortunately, the investigators believed that the symptoms observed may not have been due to the challenge virus, but other respiratory infections acquired in the community, thus confounding the studies. A year later, the UK’s Medical Research Council (MRC) terminated the work.
After the conclusion of World War II, the withdrawal of the US troops from the UK left the American Red Cross ‘Harvard Hospital’ Field Unit on Salisbury plain. The hospital became the Common Cold Unit (CCU) led by Dr David Tyrell, from 1946, volunteers were inoculated by instilling small quantities of the virus into their noses. The CCU housed healthy volunteers in relative isolation from other people, thereby reducing the risk of contact with community-acquired sources of infection or from them passing on the virus to members of the public.… Read the rest “A BRIEF HISTORY OF THE HUMAN VIRAL CHALLENGE (HVC) MODEL.”
Along with colleagues, I am finalising a proposal to develop a consortium and produce “Regulatory Guidelines for the Manufacture of Human Challenge Agents”.
We are responding to the joint request from The Wellcome Trust and HIC-vac (https://lnkd.in/etsQW_W).
So that we can understand better what peoples’ expectations are it would be very helpful if colleagues could spare a few minutes to answer eight quick questions in the survey below.
Many thanks in advance and please feel free to forward details of this poll to anyone you feel may find it useful.
The Human Viral Challenge Model demonstrates Highly Statistically Significant Reductions in Total Symptom Score, Mucus Weight and RSV Viral Load for Enanta’s new N protein inhibitor. http://ow.ly/hrWy30pFaJZ
Read the original article in full on Wellcome Open Research: Expert voices and equal partnerships: establishing Controlled Human Infection Models (CHIMs) in Vietnam
— Read on wellcomeopenresearch.org/articles/4-143