Leiden University Medical Center and Intravacc to start clinical trial with new intranasal corona vaccine

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

Intravacc has 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 a perfect solution for people 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 organisations.

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.

Mode of action

NANOVAC is intended to protect humans against current and future COVID-19 variants. The nano vaccine candidate is not only based on spike protein but also other target proteins in the coronavirus. It consists of a nanoparticle formulation containing multi-epitopes polypeptides of the immunogenic spike (S) protein of SARS-CoV-2 (COVID-19), as well as other 100 per cent conserved epitopes derived from distinct coronavirus proteins of which important targeting has already been identified for inducing a complete humoral systemic and mucosal immune response, and cellular immunity response, both neutralizing antibodies and T cells, both for immediate immunization, and for a longer-term defense.

To enhance the effectiveness, the adjuvant hepatitis B core antigen HBcAg is used, which already has a proven effect in a nasal spray vaccine against liver inflammation. The HBcAG particle has been safely administered intranasally, serving as a carrier for nasal route and an immunostimulant for the mucosal immune cells of the nasal passages and upper respiratory tract. The vaccine does not apply the more recently used mRNA technique or of inactivated cold viruses (vectors).