drugset

drugset / Trial / NCT05389319

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

NCT05389319 ↗

Phase 1 Active not recruiting 96 enrolled University Hospital Tuebingen FGK Clinical Research GmbH · collab Staburo GmbH · collab Viedoc Technologies AB · collab VisMederi srl · collab

Non-randomizedSequentialOpen-labelPrevention

Summary

This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants.

Timeline

Start: 2022-06-24
Primary completion: 2026-12-31
Completion: 2026-12-31

Publications

Esen M, Fischer-Herr J, Gabor JJ, Gaile JM, Fleischmann WA, Smeenk GW, de Moraes RA, Belard S, Calle CL, Woldearegai TG, Egger-Adam D, Haug V, Metz C, Reguzova A, Loffler MW, Balode B, Matthies LC, Ramharter M, Amann R, Kremsner PG. First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster. Vaccines (Basel). 2024 Nov 18;12(11):1288. doi: 10.3390/vaccines12111288.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prime-2-CoV_Beta	Vaccine	30000 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	300000 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	3e+06 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	3e+07 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	6e+07 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	1.5e+08 unknown	Intramuscular
Subject	Prime-2-CoV_Beta	Vaccine	1.2e+09 unknown	Intramuscular

Indications