RSV Research & Clinical Trials
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 disease model has been used in revolutionary clinical studies to identify novel RSV therapeutics that reduce viral load and reduce symptoms, enabling clients to advance these therapeutics forward towards approval. Several of these are highlighted in our case studies below.
To date, specific to RSV, we have conducted over a dozen clinical studies for a range of leading industry, governmental and academic clients, making it one of the most respected commercial disease models for RSV.
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.
- The study was a randomised, double‑blind, placebo‑controlled Phase 2 challenge study of AL‑ 8176 (lumicitabine) 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.
- The study was subsequently published in the New England Journal of Medicine in 2015- Learn more here.
John Fry, Vice President, Head of Early Development, Infectious Diseases, Alios BioPharma, part of the Janssen Pharmaceutical Companies 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.”
Gilead GS-5806 study : 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, learn more here. The paper was authored by Dr. 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.
In addition to being used with traditional antiviral compounds, our RSV platform has been used in studies successfully investigating new classes of drugs that target the viral RNA using siRNA and for conducting vaccine efficacy testing. 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. Volunteers typically stay in the quarantine unit for 12-15 days, with potential follow up visits post-discharge as required for the study.
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? Learn more here