Phase I/II COVID-19 vaccine trial in humans

Radboudumc has started a clinical phase I/II study on 15 March 2021 for the ABNCoV2 capsid virus-like particle (cVLP) based COVID-19 vaccine. This clinical phase I/II study, also known as COUGH-1, has as main trial objectives to assess the safety and tolerability of two doses of ABNCoV2. The study has been approved by the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands.

This clinical research at Radboudumc is led by professor of medical microbiology Benjamin Mordmüller, who until recently was affiliated with the University of Tübingen in Germany. An expert in vaccine development and human clinical research, Mordmüller starts his clinical activities at Radboudumc with a European Commission-funded ABNCoV2 vaccine research project. Mordmüller: “Up to 42 participants will be vaccinated for this study to investigate safety and secondary parameters. The first Phase I / IIa clinical results are expected in the first quarter of 2021. ”

Clinical phase I/II study for the ABNCoV2 vaccine (COUGH-1)

The clinical phase I/II study, also known as COUGH-1, has as main trial objectives to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio following first vaccination with ABNCoV2. COUGH-1 is a phase 1, single centre, open labelled trial in healthy, adult, SARS-CoV-2-naïve volunteers. The trial involves first-in-human administration, pre-defined, sequential dose escalation of ABNCoV2, and adjuvant selection. It intends to inform dosage and formulation for subsequent clinical development.

The PREVENT-nCoV consortium

The consortium is funded by an EU Horizon 2020 grant to develop a COVID-19 vaccine. The consortium members cover all relevant areas of viral research and vaccine development required for rapid clinical development of a COVID-19 vaccine. This includes pre-clinical and clinically validated experience from working with similar Coronaviruses such as MERS and SARS, ExpreS2ion’s Drosophila S2 insect cell expression system (ExpreS2), and AdaptVac’s capsid virus-like particle (cVLP) technology. Besides ExpreS2ion and AdaptVac, the consortium members are Leiden University Medical Center (LUMC), Institute for Tropical Medicine (ITM) at University of Tübingen, the Department of Immunology and Microbiology (ISIM) at University of Copenhagen, the Laboratory of Virology at Wageningen University, and the Radboud university medical center (RUMC).

First-in-human clinical trial at Radboudumc

Radboud university medical center is responsible for design, conduct and reporting of the first-in-human clinical trial. The first human dosing was given on March 15th. The trial is designed to assess the cVLP technology in combination with SARS-CoV2 antigens to safely induce a strong and long-lasting immune response with and without the immune-enhancing compound MF59, an adjuvant that is already marketed as part of influenza vaccines.

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