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

A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Speransa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Phase 1 dose-finding study (ORFEUS) will assess the safety, tolerability and immunogenicity of a two-dose regimen (28-days apart) of PRIME-2-CoV\_Beta administered by intramuscular (IM) route in adult participants. In the first part, the safety and immunogenicity of increasing doses of PRIME-2-CoV\_Beta will be assessed in adult healthy participants aged 18 to 55 years who have been vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine (i.e. primary sequence with or without booster vaccination, subsequently referred to as "pre-vaccinated"). In addition, one dose level which has been identified as optimal will be assessed in a small cohort (12 participants) of participants 18 to 55 years of age who are SARS-CoV-2 vaccine-naïve. In addition, three dose levels identified in pre-vaccinated participants will be further evaluated for safety and immunogenicity in pre-vaccinated elderly participants aged 65-85 years (B-cohorts).

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	PRIME-2-CoV_Beta	Intramuscular (IM) injection

Timeline

• Start date: 2022-06-20
• Primary completion: 2023-07-18
• Completion: 2023-11-08
• First posted: 2022-05-10
• Last updated: 2024-02-09

Locations

7 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study