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First-in-human phase I trial to assess the safety and immunogenicity of an Orf virus-based COVID-19 vaccine booster

The emergence of SARS-CoV-2 has necessitated the development of versatile vaccines capable of addressing evolving variants. Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express the SARS-CoV-2 spike and nucleocapsid antigens. This first-in-human, phase I, dose-finding...

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Hauptverfasser: Esen, Meral (VerfasserIn) , Fischer-Herr, Johanna (VerfasserIn) , Gabor, Julian Justin (VerfasserIn) , Gaile, Johanna Marika (VerfasserIn) , Fleischmann, Wim A. (VerfasserIn) , Smeenk, Geerten Willem (VerfasserIn) , de Moraes, Roberta Allgayer (VerfasserIn) , Bélard, Sabine (VerfasserIn) , Calle, Carlos Lamsfus (VerfasserIn) , Woldearegai, Tamirat Gebru (VerfasserIn) , Egger-Adam, Diane (VerfasserIn) , Haug, Verena (VerfasserIn) , Metz, Carina (VerfasserIn) , Reguzova, Alena (VerfasserIn) , Löffler, Markus W. (VerfasserIn) , Balode, Baiba (VerfasserIn) , Matthies, Lars C. (VerfasserIn) , Ramharter, Michael (VerfasserIn) , Amann, Ralf (VerfasserIn) , Kremsner, Peter (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 18 November 2024
In: Vaccines
Year: 2024, Jahrgang: 12, Heft: 11, Pages: 1-21
ISSN:2076-393X
DOI:10.3390/vaccines12111288
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.3390/vaccines12111288
Verlag, kostenfrei, Volltext: https://www.mdpi.com/2076-393X/12/11/1288
Volltext
Verfasserangaben:Meral Esen, Johanna Fischer-Herr, Julian Justin Gabor, Johanna Marika Gaile, Wim Alexander Fleischmann, Geerten Willem Smeenk, Roberta Allgayer de Moraes, Sabine Bélard, Carlos Lamsfus Calle, Tamirat Gebru Woldearegai, Diane Egger-Adam, Verena Haug, Carina Metz, Alena Reguzova, Markus W. Löffler, Baiba Balode, Lars C. Matthies, Michael Ramharter, Ralf Amann and Peter G. Kremsner
Beschreibung
Zusammenfassung:The emergence of SARS-CoV-2 has necessitated the development of versatile vaccines capable of addressing evolving variants. Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express the SARS-CoV-2 spike and nucleocapsid antigens. This first-in-human, phase I, dose-finding clinical trial was conducted to assess the safety, reactogenicity, and immunogenicity of Prime-2-CoV_Beta as a booster in healthy adults. From June 2022 to June 2023, 60 participants in Germany received varying doses of Prime-2-CoV_Beta. The study demonstrated a favorable safety profile, with no serious adverse events (AEs) reported. All AEs were mild (107) or moderate (10), with the most common symptoms being pain at the injection site, fatigue, and headache. Immunogenicity assessments revealed robust vaccine-induced antigen-specific immune responses. High doses notably elicited significant increases in antibodies against the spike and nucleocapsid proteins as well as neutralizing antibodies against SARS-CoV-2 and its variants. Additionally, the vaccine did not induce ORFV-neutralizing antibodies, indicating the potential for repeated administration. In conclusion, Prime-2-CoV_Beta was safe, well tolerated, and immunogenic, demonstrating potential as a broadly protective vaccine against SARS-CoV-2 and its variants. These promising results support further evaluation of higher doses and additional studies to confirm efficacy and long-term protection. This trial was registered at ClinicalTrials, NCT05389319.
Beschreibung:Gesehen am 11.07.2025
Beschreibung:Online Resource
ISSN:2076-393X
DOI:10.3390/vaccines12111288

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