CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 96 target
Drug / intervention
Prime-2-CoV_Betabiological
Likely dose
Prime-2-CoV_Beta 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05389319
NCT05389319Phase 1ActiveOn Track
CompareCT.gov

A Phase I/IIa, Dose-finding Study to Assess the Safety and Immunogenicity of an Orf Virus-based COVID-19 Vaccine Booster (Prime-2-CoV_Beta) in Healthy Adults

University Hospital Tuebingen·interventional·Posted May 25, 2022·Updated Jun 15, 2026

In Brief

A Phase 1 clinical trial evaluating Prime-2-CoV_Beta for COVID-19. Active but no longer recruiting, targeting 96 participants across 2 sites.

Detailed Summary

This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesGermany
CollaboratorsFGK Clinical Research GmbH, VisMederi srl, Staburo GmbH, Viedoc Technologies AB

Timeline

Phase 1Active
20232024202520262027
First PostedMay 25, 2022
Enrollment StartJun 24, 2022
Primary CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 4.1 years agoPrimary completion in 6 months

Arms & Interventions

Cohort 1experimental

Prime-2-CoV\_Beta, dose: 30 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 2experimental

Prime-2-CoV\_Beta, dose: 300 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 3experimental

Prime-2-CoV\_Beta, dose: 3 000 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 4experimental

Prime-2-CoV\_Beta, dose: 150 000 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 5experimental

Prime-2-CoV\_Beta, dose: 30 000 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 6experimental

Prime-2-CoV\_Beta, dose: 60 000 000 PFUs

Biological: Prime-2-CoV_Beta
Cohort 7experimental

Prime-2-CoV\_Beta, dose: 1 200 000 000 PFUs

Biological: Prime-2-CoV_Beta

Interventions

Prime-2-CoV_Betabiological

1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1