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Leiden Medical Center and Intravacc to Start Clinical Trial with New Intranasal Corona Vaccine

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Leiden Medical Center and Intravacc to Start Clinical Trial with New Intranasal Corona Vaccine | Pharmtech Focus

Intravacc, a global leader in translational research and development of therapeutic vaccines and vaccines against infectious diseases, today announced a partnership with Dutch Leiden University Medical Center (LUMC) to develop and evaluate a new nasal spray corona vaccine in a clinical phase I/II study. This new vaccine, NANOVAC, is based on microscopic soluble nano-spheres, containing synthetic mini proteins that, when administered as a nasal spray, directly protects the upper respiratory tract including nasal passages and throat (mucosa) before the virus reaches the lungs. The design of this type of vaccine thereby makes the vaccine broadly protective, harnessing both arms of the immune system, against SARS-2 (COVID19) but also SARS-1, MERS, and other beta coronaviruses. Intravacc also develops AVACC-10, a nasal spray corona vaccine based on Outer Membrane Vesicles. Nasal spray vaccines are ideal to prevent and stop transmission to others and for those with needle stick fears.

The planned clinical phase I/II study is made possible in part by the Top Consortium for Knowledge and Innovation (TKI) of Health~Holland, part of the Dutch top sector Life Sciences & Health. Health~Holland plays a connecting role between the business community, government, research institutes, patients and social organizations.

Dr. Luis Cruz’s team, responsible for LUMC’s Translational Nanobiomaterials and Imaging department, spent more than a year working on the new, sustainable and simple nasal spray vaccine. The preclinical studies in animals showed surprisingly positive results. The phase I/II clinical study is led by Dr Leo Visser of the Infectious Diseases Department of the LUMC. Intravacc will focus on a number of additional and preliminary preclinical exercises and the process development research of the vaccine through a scalable vaccine production process using its expertise in GMP vaccine production. The nasal spray vaccine will be tested on healthy volunteers to evaluate safety and tolerability. This phase I/II clinical trial is expected to start at the end of 2022 and the first study data is expected in the first half of 2023.

Dr. Luis J. Cruz, head of LUMC’s Translational Nanobiomaterials and Imaging department, said:

“Intravacc and LUMC create major synergy by combining distinct complimentary expertises and competencies. A promising collaboration!”

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