NCT05389319

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Eligible participants will undergo baseline assessments and will receive 1 injection of Prime-2-CoV\_Beta at Day 1. Participants will be followed up through 6 months post-booster vaccination. Follow-up visits will be performed at Days 4, 8, 15, 29, and Months 3 and 6, to assess the safety, tolerability, and immunogenicity of Prime-2-CoV\_Beta. Additional safety and tolerability data will be assessed 1 day and 2 days after booster vaccination (Days 2 and 3) by telephone. Initially, a total of 60 participants were planned to be vaccinated in 5 cohorts of 12 participants each. Dose ranging of Prime-2-CoV\_Beta was planned to be done by dose escalation with doses ranging from 3x104 plaque forming units (PFUs) up to 3x10\^7 PFUs. With protocol Version 7.0, Cohort 6 with 12 participants was added with 6x10\^7 PFU. With protocol Version 8.0, 1 additional cohort, Cohort 7 (1.2x10\^8 PFU, stratified by previous COVID-19 vaccinations and previous SARS-CoV-2 infections) with 24 participants will be added (total number thus 96 participants). Procedures for Cohorts 6 and 7 will be the same as for Cohorts 1 - 5, except that for some participants in Cohort 7 ORFV shedding in urine, saliva, blood, and stool will be evaluated.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Prime-2-CoV_Beta	1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1

Timeline

• Start date: 2022-06-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-05-25
• Last updated: 2026-04-07

Locations

2 sites across 1 country: Germany