drugset / Trial / NCT05367843

A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins

NCT05367843 ↗

Phase 1 Terminated 103 enrolled Speransa Therapeutics
Non-randomizedSequentialOpen-labelPrevention

Summary

PRIME-2-CoV\_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.

Timeline

Start
2022-06-20
Primary completion
2023-07-18
Completion
2023-11-08

Outcome

Outcome not reported

Stopped (Business): “Business Decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject Prime-2-CoV_Beta Vaccine 300000 unknown —
Subject Prime-2-CoV_Beta Vaccine 3e+06 unknown —
Subject Prime-2-CoV_Beta Vaccine 1.5e+07 unknown —
Subject Prime-2-CoV_Beta Vaccine 3e+07 unknown —

Indications