PRIME-2-CoV_Beta / Prime Vector Technologies - LARVOL DELTA

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Suspended | Sponsor: University Hospital Tuebingen | Trial completion date: Dec 2025 ➔ Aug 2028 | Trial primary completion date: Jan 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Suspended | Sponsor: University Hospital Tuebingen | Recruiting ➔ Suspended

Trial suspension • Infectious Disease • Novel Coronavirus Disease

First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster. (PubMed, Vaccines (Basel)) - P1 | "Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express the SARS-CoV-2 spike and nucleocapsid antigens...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."

Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity. (PubMed, Hum Vaccin Immunother) - P1 | "Prime-2-CoV_Beta is an orf virus (ORFV) based multi-antigen COVID-19 vaccine that co-expresses Spike (S) and Nucleocapsid (N) antigens...No pre-existing or vaccine-induced neutralizing anti-vector antibodies are detected. Our findings highlight the potential of the ORFV vector as a safe platform for future vaccine design, which provides the ability to deliver multiple antigens and allows for repeat immunization."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Novel Multi-Antigen Orf-Virus-Derived Vaccine Elicits Protective Anti-SARS-CoV-2 Response in Monovalent and Bivalent Formats. (PubMed, Vaccines (Basel)) - "We furthermore showed that Prime-2-CoV_Beta-based mono- and bivalent immunization strategies produced comparable immunogenicity and protection from infection. Our results highlight the potential of the Orf virus as a vaccine platform against SARS-CoV-2 and potentially other infectious viruses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ORFEUS: 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 (clinicaltrials.gov) - P1 | N=103 | Terminated | Sponsor: Speransa Therapeutics | Completed ➔ Terminated; Business Decision

Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University Hospital Tuebingen | Trial completion date: Feb 2023 ➔ Dec 2025 | Trial primary completion date: Feb 2023 ➔ Jan 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

ORFEUS: 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 (clinicaltrials.gov) - P1 | N=103 | Completed | Sponsor: Speransa Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Nov 2023

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ORFEUS: 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 (clinicaltrials.gov) - P1 | N=103 | Active, not recruiting | Sponsor: Speransa Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ORFEUS: 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 (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Speransa Therapeutics | Trial completion date: Jul 2023 ➔ Jun 2024 | Trial primary completion date: Sep 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University Hospital Tuebingen | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

ORFEUS: 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 (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Speransa Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase Ia, Dose-finding Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: University Hospital Tuebingen

New P1 trial • Infectious Disease • Novel Coronavirus Disease

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 (ORFEUS) (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Speransa Therapeutics

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases