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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2024-02-09
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.
Conditions
Interventions
- DRUG
-
PRIME-2-CoV_Beta
Intramuscular (IM) injection
Sponsors & Collaborators
-
Speransa Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-20
- Primary Completion
- 2023-07-18
- Completion
- 2023-11-08
- FDA Drug
- Yes
Countries
- United States
- Germany
Study Locations
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