First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster.
Meral Esen, Johanna Fischer-Herr, Julian Justin Gabor...
https://pubmed.ncbi.nlm.nih.gov/39591190Actively Recruiting
Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID05389319
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
Led by University Hospital Tuebingen · Updated on 2026-04-07
96
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
F
FGK Clinical Research GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, first-in-human, dose-finding study to evaluate the safety and immune response of a COVID-19 vaccine booster called Prime-2-CoV_Beta in healthy adults aged 18 to 55 years. This phase 1 study aims to find the best dose while monitoring for side effects and antibody levels after the booster. The study includes participants with previous COVID-19 vaccinations or infections, with a total of up to 96 participants planned across several dose groups. Participants receive a single intramuscular injection of Prime-2-CoV_Beta at Day 1. The doses vary widely, from 30,000 to 1,200,000,000 plaque forming units (PFUs), tested across seven cohorts. Follow-up visits occur at Days 2, 3 (phone calls), 4, 8, 15, 29, and at Months 3 and 6 to monitor safety and immune response. Some participants in the highest dose group will have additional tests to detect virus shedding in urine, saliva, blood, and stool. Throughout the study, participants undergo assessments including physical exams, blood tests for antibody levels, and monitoring for side effects such as injection site pain, fever, or fatigue. The main outcomes measured are the proportion of participants experiencing adverse events and the levels of neutralizing and IgG antibodies against SARS-CoV-2. The entire participation lasts about six months, during which safety, tolerability, and immune response data are collected and analyzed.
CONDITIONS
Brief Title
A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy adult men or women aged 18 to 55 years
- Previous COVID-19 vaccination and/or SARS-CoV-2 infection as specified for cohorts
- Able to understand study information and provide written informed consent
- Body mass index between 18.5 and 30.0 kg/m² and weight over 50 kg at screening
- Women of childbearing potential must have negative pregnancy tests and agree to use highly effective contraception from 14 days before vaccination until study end
- Male participants must agree to avoid fathering a child or donate sperm during the study and use adequate contraception if applicable
- Willing and able to comply with all study procedures as judged by the investigator
You will not qualify if you...
- Receipt of any vaccine within 4 weeks before or planned during the study until 6 weeks after booster vaccination
- Previous COVID-19 vaccination with non-mRNA vaccines for certain cohorts
- Treatment with investigational drugs or devices within 30 days before enrollment
- Immunoglobulins or blood products within 2 months before booster vaccination
- Chronic use of medications that impair immune response within 2 months before vaccination (except certain corticosteroids)
- Active COVID-19 infection or quarantine at Day 1
- Severe allergic reactions to vaccines or study components
- History of angioedema
- Pregnant or lactating women
- Immunosuppressive or immunodeficient conditions
- Guillain-Barré Syndrome history
- Infection with HIV, hepatitis B or C
- Active cancer within 5 years (except certain skin cancers)
- Moderate or severe illness or fever within 1 week before vaccination
- Significant health problems or abnormal lab tests at screening
- History of cardiovascular, gastrointestinal, liver, renal, endocrine, neurological, or chronic respiratory diseases judged significant by investigator
- Alcohol or drug abuse within 6 months before vaccination
- Current participation in another study or previous enrollment
- Investigator, study staff, or relatives involved in study
- Prolonged exposure to sheep or goats (e.g., farmers)
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 day
Participants receive 1 injection of the Prime-2-CoV_Beta COVID-19 vaccine booster on Day 1.
1 vaccination visit (in-person)
Follow-up
Duration - 6 months post-vaccination
Participants are followed up to monitor safety, tolerability, and immune response after vaccination. Follow-up includes telephone assessments on Days 2 and 3 and in-person visits on Days 4, 8, 15, 29, and Months 3 and 6.
Telephone calls on Days 2 and 3; in-person visits on Days 4, 8, 15, 29, Month 3, and Month 6
Trial Site Locations
Total: 2 locations
1
University Hospital Tübingen, Institute of Tropical Medicine
Tübingen, Baden-Wurttemberg, Germany, 72074
Actively Recruiting
2
Bernhard-Nocht-Institut für Tropenmedizin
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20359
Actively Recruiting
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Research Team
U
University Hospital Tübingen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
7
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