A multiantigenic Orf virus-based vaccine efficiently protects hamsters and nonhuman primates against SARS-CoV-2

npj Vaccines, Journal Year: 2024, Volume and Issue: 9(1)

Published: Oct. 16, 2024

Abstract Among the common strategies to design next-generation COVID-19 vaccines is broadening antigenic repertoire thereby aiming increase efficacy against emerging variants of concern (VoC). This study describes a new Orf virus-based vector (ORFV) platform multiantigenic vaccine targeting SARS-CoV-2 spike and nucleocapsid antigens. Vaccine candidates were engineered, either expressing protein (ORFV-S) alone or co-expressing (ORFV-S/N). Mono- elicited comparable levels spike-specific antibodies virus neutralization in mice. Results from challenge model hamsters suggest cross-protective properties VoC, indicating improved viral clearance with ORFV-S/N, as compared equal doses ORFV-S. In nonhuman primate model, vaccination ORFV-S/N resulted long-term protection infection. These results demonstrate potential ORFV for prophylactic represent preclinical development program supporting first-in-man studies vaccine.

Language: Английский

First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster

Vaccines, Journal Year: 2024, Volume and Issue: 12(11), P. 1288 - 1288

Published: Nov. 18, 2024

The emergence of SARS-CoV-2 has necessitated the development versatile vaccines capable addressing evolving variants. Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express spike and nucleocapsid antigens. This first-in-human, phase I, dose-finding clinical trial conducted assess safety, reactogenicity, immunogenicity Prime-2-CoV_Beta as booster in healthy adults. From June 2022 2023, 60 participants Germany received varying doses Prime-2-CoV_Beta. study demonstrated favorable safety profile, with no serious adverse events (AEs) reported. All AEs were mild (107) or moderate (10), most common symptoms being pain at injection site, fatigue, headache. Immunogenicity assessments revealed robust vaccine-induced antigen-specific immune responses. High notably elicited significant increases antibodies against proteins well neutralizing its Additionally, vaccine did not induce ORFV-neutralizing antibodies, indicating potential for repeated administration. In conclusion, safe, tolerated, immunogenic, demonstrating broadly protective These promising results support further evaluation higher additional studies confirm efficacy long-term protection. registered ClinicalTrials, NCT05389319.

Language: Английский