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Institute of Novel and Emerging Infectious Diseases (INNT

Prevention of Viral Diseases with Epidemic and Pandemic Potential through Development and Clinical Testing of a Novel Virus Like Particle (VLP) Vaccine (VICI-Disease)

INNT

Funding: EU

Duration: 12/2023 – 11/2027

We will develop and characterize three preclinical vaccine candidates targeting the highly pathogenic viruses Nipah, Ebola Sudan and Marburg virus. For each of these viruses, we will design a number of vaccine constructs and then perform biophysical characterization (e.g. production yield, receptor binding, VLP coupling efficiency, TEM). This will be followed by measuring initial vaccine immunogenicity in mice using in vitro virus neutralization assays (VNT) performed at the FLI under BSL4 conditions. This offers the opportunity to rapidly gain early insight into the potential efficacy of the final vaccine candidate. The lead candidate (preferably against Nipah virus) will be selected, based on biophysical characterization and in vitro virus neutralization results, and tested in challenge experiments in at least two animal models at the FLI under BSL4 conditions. Progressing from successful animal challenge data, the lead virus candidate will then be advanced to GMP manufacture and a Phase 1/2a clinical study at Radboud UMC. Successful safety and induction of neutralizing antibody responses raised by the volunteers in the Phase 1/2a study will then allow initiation of a pivotal Phase 2/3 program once further funding or licensing to a Large-Biotech/ Pharma partner is secured.

Involved Scientists:

PD Dr. Anne Balkema-Buschmann

Dr. Sandra Diederich

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VICI-Disease Scheme

VICI-Disease Scheme (© FLI)