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Infectious Disease and Vaccines

WCCT update to coronavirus

***If you are interested in conducting a clinical trial for a vaccine or anti-viral targeting COVID-19, please reach out to us via our website here***

Infectious Diseases and Vaccines

A breadth of experience in both therapeutic and preventative clinical development.

Since our founding in 1998, WCCT has conducted over 80 clinical trials in the area of Infections and Infectious Disease. Supported by expert scientific, medical, regulatory, and clinical staff, the WCCT clinical pharmacology unit supports the streamlined clinical development of  new vaccines, anti-viral therapeis, delivery systems, and antimicrobial agents in a timely, cost-effective manner. Partner with a leader that has a track record in infectious diseases.

WCCT has infectious disease experience in the following indications:
  • Bacterial infection
  • Common cold
  • MERS
  • HBV
  • HCV
  • HIV
  • RSV
  • Complicated skin infections
  • Fungal infections
  • Herpes Zoster
  • Influenza

Vaccines

Within this broad therapeutic area, WCCT has also developed a specific expertise in the development of new vaccines for various indications. Since 2008, we have conducted over 20 vaccine trials for the following conditions:

  • Seasonal influenza
  • Pandemic influenza
  • Norovirus
  • Hepatitis B
  • HPV
  • HSV

With a comprehensive understanding of FDA regulations and requirements for vaccine approval, and access to a large database of clinical research volunteers, we are uniquely positioned to streamline the clinical development of new vaccines and delivery systems.

In-House Vaccine Development Capabilities:
  • Robust database of 55,000 clinical research volunteers ready to participate in vaccine trials
  • Three distinct wards within our 180-bed clinical pharmacology unit which can be used to separate volunteers and are customizable to the needs of the protocol
  • CAP Accredited and CLIA Certified Safety Reference Laboratory with the following features relevant to vaccine testing:
    • Respiratory Panel Testing through the BioFire FilmArray Multiplex PCR System to evaluate the presence of an infection in the respiratory tract of immuno-compromised patients
      • Staff trained to collect samples using nasopharyngeal swabs
    • Ability to isolate Peripheral Blood Mononuclear Cells (PBMCs) through multiple collection methods dependent upon Sponsor goals—PBMCs are a means to evaluate the immune response of cells under various conditions
    • Biosafety Laboratory Level 2 facility with limited badge access, several biosafety cabinets, BioHazard-trained staff, cleaning protocols, and procedures in-place for containment issues
    • Long-term sample storage. Planned Biorepository accreditation in May 2020: Accreditation represents compliance with:
      • GCLP guidelines for sample processing and storage
      • FDA, CAP, and the Center for Medicaid Services for safety monitoring, sample collection, source document creation, data management, biostatistical analysis, and more
WCCT conducts Viral Challenge trials at our Phase I unit in Cypress, CA, with private rooms to allow for isolation, safety, and privacy. Our Influenza Challenge capabilities will be moving to this facility and available in Spring of 2020.

Influenza Challenge Model

WCCT has partnered 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). WCCT has 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:

  • 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
    • View WCCT’s PBMC isolation process here
    • View our press release on PBMC training and certification
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