Vaccines and Influenza Challenge Study Facility
The first and only commercial U.S. clinical pharmacology unit able to conduct Influenza clinical research.
Influenza Challenge Model
WCCT wholly owns a U.S.-based influenza challenge study facility. This study unit houses 30 private rooms.
WCCT is partnering with biotech and pharma companies, along with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), in executing a proof-of-concept model called the Influenza Challenge Model (ICM). The program is carried out in our Costa Mesa, CA, Clinical Pharmacology Unit (CPU). In fact, WCCT is the first ever influenza challenge facility approved for commercial use in the United States.
The Influenza Challenge Model is a research study design where developers of influenza antivirals and vaccines test whether their intervention will prevent (prophylaxis) or treat individuals who come down with influenza. Infectious disease researchers have developed strains of influenza currently circulating in the general populations. These constructed strains serve as a “challenge virus,” which can be administered to healthy volunteers who have received a therapeutic, vaccine or placebo intervention.
Healthy volunteers have been determined to be potentially susceptible to influenza infection following exposure to the virus. Once their overall health is thoroughly evaluated, satisfactory candidates will be inoculated with the influenza virus after they are invited into the trial.
The goal of viral challenge studies are to provide strong, clinically meaningful evidence that the experimental vaccine or influenza treatment “works” and to identify the most appropriate dosing. Obviously, if the candidate vaccine or therapy is not seen to be effective, it will not be developed further.
The FDA’s vaccine guidance states that strong results from this model could be considered as Phase II or even Phase III pivotal results. Therefore, the Influenza Challenge Model is rapidly becoming an obligatory trial in influenza vaccine and therapeutic treatment development programs.
More information on the Influenza Challenge Model at Costa Mesa:
- 30 individual private rooms
- Separate dedicated units for virus and vaccine storage
- Between January and March 2015, WCCT recruited 400+ volunteers to test the immunity of our H1N1 virus.
- WCCT owns the only challenge virus A/California/2009 (H1N1) in the U.S. Read the press release
- In 2016, WCCT was awarded the largest-ever government-funded influenza challenge study
- Comparing whether there is a difference in symptom onset, symptom severity or objective viral shedding will shed light on whether these interventions are effective. Such research studies will allow companies to decide which development programs are worthy of moving forward into population-based Phase IIb and III studies.
- The WCCT challenge virus (A/California/H1N1 2009) was isolated from a combined nasal/throat swab obtained from a 3-year-old male child who was presented with an influenza-like illness during the 2009 flu season. The original isolate was subsequently passaged in specific pathogen-free (SPF) eggs under current Good Manufacturing Practices (cGMP) conditions. The virus has been used in multiple clinical studies with excellent viral shedding rates and no safety concerns.
- All WCCT staff are IATA certified and trained to process a wide range of samples. They are familiar with time-sensitive processing such as: PK and antibody processing, sputum samples, flash freezing and 24-hour urine collection. WCCT has the ability to perform diagnostic tests for influenza, including rapid antigen or PCR via nasopharyngeal swabs or washes. The methodology to be implemented will be determined by the sponsor’s requirements.
- Certified for PBMC isolation