Capabilities & Benefits
hVIVO has been pioneering flu challenge models since it was founded over 25 years ago. Human challenge studies, and specifically influenza challenge research programmes, provide a:
- superior alternative to early stage, field-based trials, enabling pharmaceutical and biotechnology companies to accelerate the process
- reduce the cost of bringing anti-viral drugs, diagnostics and vaccines to market.
Influenza, commonly known as “the flu”, is an infectious disease of birds and mammals caused by RNA viruses . Influenza spreads around the world in seasonal epidemics, resulting in about three to five million yearly cases of severe illness and about 250,000 to 500,000 yearly deaths, rising to millions in some pandemic years. While the most well-known pandemic was in 1918, recent pandemics have been caused by a variety of strains and even evolved from animals, such as swine flu. Clinicians have long suspected that respiratory infections, such as those caused by influenza, are a major cause of asthma and COPD.
The use of a human challenge study 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 interventions to be studied across the disease cycle. The development of these models will also permit the development of new diagnostics and companion biomarkers.
hVIVO has pioneered the use of the human challenge study to provide multiple proofs of concepts, including studies with Influenza to determine optimum doses and dosing schedules of new compounds or vaccines, leading to subsequently successful field studies. To date, specific to influenza, we have conducted over 28 clinical studies (including over 40 separate quarantines) involving more than 1,230 volunteers for a range of leading industry, governmental and academic clients.
The challenge study protocol utilising infection with Influenza has been important in developing early stage diagnostics, understanding the correlates of protection against disease, the transmission of viruses between people, and the course of respiratory virus infections.
Successful recruitment track record
With over 190,000 volunteers in its database, hVIVO has a strong track record recruiting for human challenge studies through its FluCamp arm. In present day influenza challenge studies, healthy adults are selected for relative susceptibility by serum antibody levels and infected intra-nasally with a well characterised pool of wild-type Influenza virus. Under these conditions, the majority of subjects (typically 60% to 80%) will be infected and develop a mild, influenza-like illness (ILI), accompanied by recovery of virus from the nasopharynx. This model has been used to evaluate vaccines and antiviral agents, including neuraminidase inhibitors, for both prophylaxis and treatment, as well as for the study of person to person transmission. In general, the results of experimental infection studies have been predictive of subsequent results in the field, making this a useful system for initial testing of potential antivirals.
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.
Standardised hVIVO study design
Conducting the human challenge study 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 hVIVO quarantine unit have been predictive of efficacy in the real world.
Rigourously characterized hVIVO influenza library
We have a library of Influenza A and Influenza B strains that have been utilized in clinical trials, including
All viruses are produced under pharmaceutical grade (GMP). Viruses undergo rigorous qualification and were found to be suitable for use in clinical trials.
Subjects monitored during entire disease cycle
The use of a human challenge study 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.
Interested in participating in a clinical trial?
Human volunteers are at the heart of all we do. Human challenge 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 .