INDIGO project starts Phase 1 trial
Phase 1 trial with a novel, adjuvanted, low-dose influenza vaccine (TETRALITE)
Oss/Ghent, Netherlands/Belgium, October 2022 – INDIGO, a consortium of public and private R&D organisations for development of improved influenza virus vaccines, has started a Phase 1 trial with a novel, adjuvanted, low-dose seasonal influenza vaccine. Safety, tolerability, and immunogenicity of TETRALITE, a combination of 1/5th of a dose of a licensed influenza vaccine and the novel LiteVax Adjuvant, will be investigated in healthy subjects.
In nonclinical studies, TETRALITE generated unprecedently high immune responses without detectable systemic or local side-effects. This first-in-human trial marks an important milestone in the collaborative research of the Center for Vaccinology (Ghent), HarmonyCR (Melle) and LiteVax BV (Oss) towards a better and affordable seasonal influenza vaccine for the world.
INDIGO is an interdisciplinary consortium consisting of 16 partners from India, EU and US funded by the European Union Horizon 2020 program and the Department of Biotechnology, Ministry of Science and Technology, Government of India (grant ID 874653; www.indigo-vaccines.eu).
The Centre for Vaccinology (CEVAC), Ghent University Hospital and Ghent University, is dedicated to contributing to the development of effective vaccines for the prevention of infectious diseases. CEVAC has a clinical trial unit and an immunomonitoring lab with over 25 years of experience in conducting clinical vaccine trials using the highest quality standards (www.uzgent.be).
LiteVax BV is a biopharmaceutical company focusing on the development of novel vaccine adjuvants. The versatile adjuvant technology exploited in TETRALITE is based on a synthetic carbohydrate fatty acid monosulphate ester (www.litevax.com) and investigated with other vaccines.
For more information on the INDIGO Project, please contact e.vanriet@aighd.org.
For more information on the Clinical Trial, please contact isabel.lerouxroels@uzgent.be.
For more information on the LiteVax Adjuvant, please contact luuk.hilgers@litevax.com