RSV Research & Clinical Trials
Capabilities & Benefits
In 2014, the hVIVO RSV research model has become the gold standard for human challenge studies.
Respiratory Syncytial Virus (RSV) is a lung infection responsible for as many as 125,000 hospitalisations annually of children under the age of one, according to the Centres for Disease Control and Prevention (USA). It infects over half of all infants in their first year of life and is the single most common cause of hospitalisation in infants. Even given these remarkable statistics, there are no known treatments approved for RSV.
Proven Gold Standard
Our RSV strains have been used in revolutionary clinical studies that has enabled organizations to identify novel RSV therapeutics that reduce viral load and reduce symptoms, enabling clients to advance these therapeutics forward towards approval . This has led to several publications. Find out more by clicking here to see our infographic on the Gilead study and also see the Alios Case Study below.
To date, specific to RSV, we have conducted over 17 clinical studies (including over 40 separate quarantines) involving more than 750+ volunteers for a range of leading industry, governmental and academic clients.
In addition to be using with traditional antiviral compounds, our RSV platform was used in studies successfully investigating new classes of drugs that target the viral RNA using siRNA. It enables organizations to test both traditional dosing regimes as well as leverage adaptive design and test dose ranging studies, refining schedule based on early study results
Standardized hVIVO Study Design
At hVIVO, human challenge studies take place in the company’s unique, purpose-built quarantine facilities, where healthy volunteers are isolated before being infected with a respiratory virus.
Conducting the human challenge model approach in a controlled quarantine environment allows for a superior study design, is more cost-effective, and critically accelerates the selection of a safe and effective dose and dosing regimen for a new antiviral drug or vaccine. Generally, results of studies of antiviral or vaccine approaches in the human challenge model have been predictive of efficacy in the real world.
Volunteers monitored during entire disease cycle
The use of a human challenge model in a controlled environment permits volunteers to be studied during the cycle of illness (i.e., before during and after infection to gain a complete picture of the infection process). This enables each subject to provide their own internal baseline and allows interventions to be studied across the disease cycle. The development of these models will also permit the development of new diagnostics and companion biomarkers.
Landmark hVIVO study for Alios
hVIVO’s pioneering human challenge model provided positive results for a landmark human viral challenge study for Alios BioPharma Inc. during 2014. Following this study, Alios BioPharma was acquired by Johnson & Johnson for $1.7bn including the RSV antiviral therapeutic, highlighting the value these types of studies can play in identifying safe, effective therapies.
Alios BioPharma, a US clinical stage biopharmaceutical company, is developing novel antiviral therapies for the treatment of respiratory diseases and turned to hVIVO to provide and efficacy test and establish proof of concept and dose‑ranging using the pioneering hVIVO platform designed
for investigational new drugs early on in their development lifecycle.
This viral challenge model study was conducted at our clinical quarantine unit in London, with a total of 62 volunteers enrolled across three quarantine periods, providing the opportunity to use an adaptive design, with client‑led dosage changes mid‑study.
The study was a randomised, double‑blind, placebo‑controlled Phase 2 challenge study of AL‑ 8176 in healthy adult volunteers. AL‑8176 achieved a reduction in viral load and improvement in symptom scores, and the drug is now progressing through the regulatory framework.
John Fry, Associate Director, Clinical Operations at Alios BioPharma, Inc., said: “It is an evolving field. We benefitted hugely from this (hVIVO challenge study) and I think our programme has moved at a faster pace than if we had gone out and tried to do a field‑based study.”
The study of Alios’ AL‑8176 product for RSV infection highlighted hVIVO’s ability to surpass field‑based studies in producing clean compelling data in an accelerated timeframe, through targeted subject recruitment and defined timing of infection. This underpins our expansion into new human challenge models including for respiratory diseases such asthma and Chronic Obstructive Pulmonary Disease (COPD).
Industry leaders are embracing the unique human challenge model, realising the effectiveness of taking on a viral challenge study to accelerate the process of testing new drugs on human volunteers in a respected, safe and proven environment.
Gilead GS-5806 study infographic
The scientific paper titled “Oral GS-5806 Activity in a Respiratory Syncytial Virus Challenge Study” was published in the New England Journal of Medicine (NEJM) in 2014. The paper was authored by John DeVincenzo, a Professor at University of Tennessee Health Science Centre, along with co-authors including Dr Rob Lambkin-Williams from hVIVO. It describes a double-blind, placebo-controlled human viral challenge study which was designed to establish proof of concept for GS-5806 treatment in 140 healthy adult subjects experimentally infected with RSV. The study was conducted by hVIVO at its purpose built, state-of-the-art clinical quarantine unit in London over a 10 month period starting in late 2012. The paper concluded that “Treatment with GS-5806 reduced the viral load and the severity of clinical disease in a challenge study of healthy adults. Click here to see our Gilead GS-5806 study infographic.
How we do it
Our approach is different. By carefully selecting human volunteers and monitoring them throughout a disease episode under tightly controlled medical quarantine conditions, we can demonstrate proof of concept for a new investigational drug or other therapeutic in a much shorter timeframe and in fewer subjects than traditionally, and crucially before investing in large, expensive field-based studies. hVIVO embraces the whole of our technology platform, from patient recruitment through to biomedical research and accelerated drug and vaccine development.
Our hVIVO human models of disease utilise the ability of challenge agents, such as respiratory viruses, to elicit common self-limiting diseases such as flu, cold, RSV and asthma in otherwise healthy volunteers. By watching the entire disease lifecycle as subjects move from healthy to sick and recover back to healthy again, we can obtain high quality, longitudinal data from the before, during and after phases of disease. These models can be used to study the efficacy of new therapies such as antiviral drugs and vaccines and also to study the target disease itself.
For more information on our RSV challenge studies or to make a specific research or collaboration enquiry please use the Contact Us form.
Interested in participating in a clinical trial?
Human volunteers are at the heart of all we do. Human Challenge Model studies entail working either with healthy volunteers, or with patient volunteers who suffer with a specific illness or disease that we are targeting, for further exploration and much greater in-depth understanding.
‘FluCamp’ is a volunteer recruitment brand of hVIVO Services Limited.
To find out more about the whole volunteer experience in hVIVO ‘FluCamp’ clinical trials, the science behind it, and to register your interest in volunteering, visit our dedicated FluCamp volunteer information and recruitment site at www.flucamp.com .