Solutions and capabilities
Expert partnerships
CHDR enjoys a long-standing collaboration with the Department of Infectious Diseases at the Leiden University Medical Center (LUCID), enabling us to leverage the combined expertise of infectious disease specialists and clinical pharmacologists. As leaders in the implementation of first-in-human drug trials and human challenge studies, we provide clients with the perfect setting to effectively test the safety, pharmacokinetics, immunogenicity and efficacy of new treatments and vaccine candidates. Our experience includes testing vaccine candidates for SARS-CoV-2, RSV, Rhinovirus and influenza, and investigating the pharmacokinetics of a new anti-malaria agent in combination with a controlled human malaria infection model. Upcoming and running studies include the development of controlled human infection models for RSV, Rhinovirus and influenza, in collaboration with the Leiden University Medical Center and the Leiden Controlled Human Infection Center (L-CHIC), headed by infectiologist Dr Meta Roestenberg.
The controlled infection model
In the controlled human infection model (CHIM), healthy volunteers are inoculated with a wild-type (GMP produced) viral strain, such as RSV, Rhinovirus or influenza. Subjects are administered an investigational therapeutic either before inoculation (prophylactic vaccine) or after inoculation (treatment). The CHIM is an efficient approach that can provide proof-of-concept at an early stage of development for novel vaccines, monoclonal antibodies and antivirals. Compared with traditional development approaches, this controlled infection model offers the means to make much-needed vaccines and therapeutics more rapidly available.
beReady: the fast track to vaccine research
The recent COVID-19 pandemic and the MERS, SARS and Ebola outbreaks of the last decade have highlighted the need for speed in the development of vaccines for emerging infectious diseases. In response to this need, we have joined forces with the Dutch regulators (CCMO), expert immunology laboratories and academic partners to develop beReady, CHDR’s unique fast-track protocol for vaccine research.Â
beReady includes a general clinical vaccine protocol and a consent procedure that are approved by the regulatory authority. The beReady protocol allows us to maintain a pre-screened pool of dedicated healthy volunteers, ready at a moment’s notice to be enrolled and dosed in a clinical study with a new vaccine. With this fast-track approach, the only additional approval required before study commencement concerns vaccine-specific documentation. Thanks to our partnerships with expert laboratories, we are also able to ensure rapid setup and turnaround times for viral screens. Overall, this approach promises significant reductions in the time needed to test vaccines for emerging infectious diseases, meaning that a vaccine trial can start in as little as three weeks.
Testing rhinovirus prophylaxis in a CHIM
We recently implemented a controlled human infection model (CHIM) using Rhinovirus 39 (RV39) as the challenge agent at our institute. Of the participants, 90% tested positive for RV39 by qPCR from nasal samples, and 60% developed symptomatic Rhinovirus-associated illness. These results align with previous studies using RV39, confirming the operational feasibility of the RV39 CHIM at CHDR and validating the study’s findings. Our RV39 CHIM can be utilized to assess the safety and efficacy of new compounds targeting Rhinovirus specifically, or respiratory viruses more generally. This model allows for early-phase efficacy evaluation of these compounds with a relatively small study population over a short duration.
