07 Oct INDIGO project starts Phase 1 trial

The INDIGO project, coordinated by AIGHD, has begun its phase 1 trial of a novel low-dose influenza vaccine that combines 1/5^th of a dose of a licensed influenza vaccine with a new adjuvant, an ingredient used in several vaccines to help create a stronger immune response. The INDIGO project aims to develop two novel influenza vaccine concepts that meet the requirements of global vaccination in order to lower cost and improve accessibility to the vaccine. As the coordinator of INDIGO, AIGHD’s Dr. Elly van Riet is responsible for a strong scientific coordination and collaboration between all consortium members to ensure the project is on track with respect to realization of the project objectives, conducted with high quality, and within budgetary limits.

In addition to coordinating the project, AIGHD fellows are involved in the hands-on research. AIGHD research fellow, Christopher Pell and PhD fellow Jantine van Wijlick are analysing the social and healthcare context of influenza vaccine uptake including vaccine hesitancy, acceptability of intradermal patches, and the role of healthcare workers in vaccination decision-making in both the Netherlands and India. AIGHD Senior fellow Anniek de Ruijter and PhD fellow Pramiti Parwani are focused on the regulatory landscape in, and between, the EU and India and how this affects equitable access to vaccines in low- and middle-income countries. The interdisciplinarity of the project showcases AIGHD’s strengths as a multifaceted multidisciplinary global health research institute.

Below you will find the formal press release.

Phase 1 trial with a novel, adjuvanted, low-dose influenza vaccine (TETRA^LITE)

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 TETRA^LITE, a combination of 1/5^th of a dose of a licensed influenza vaccine and the novel LiteVax Adjuvant, will be investigated in healthy subjects.

In nonclinical studies, TETRA^LITE 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 TETRA^LITE 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