Actively Recruiting
A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults
Led by University Hospital Tuebingen · Updated on 2026-04-07
96
Participants Needed
2
Research Sites
235 weeks
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
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.
CONDITIONS
Official Title
A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult men or women aged 18 to 55 years
- Previous COVID-19 vaccination and/or prior SARS-CoV-2 infection as specified for each cohort
- Ability 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 donating sperm during the study and use barrier contraception as needed
- Willingness and ability 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 vaccination until 6 weeks after the study booster
- Previous COVID-19 vaccination with non-mRNA vaccines for certain cohorts
- Recent treatment with investigational drugs or blood products within specified timeframes
- Use of medications that impair immune response within 2 months before vaccination (except certain corticosteroids)
- Active COVID-19 infection or quarantine at Day 1
- History of severe allergic reactions to vaccines or study components
- Pregnant or lactating women
- Known immunodeficiency or immunosuppressive conditions
- History of Guillain-Barré Syndrome
- Infection with HIV, hepatitis B or C viruses
- Active cancer within 5 years before Day 1 except certain skin cancers
- Recent moderate or severe illness or fever within 1 week before vaccination
- Clinically significant health problems or abnormal lab findings at screening
- History of cardiovascular, gastrointestinal, liver, renal, endocrine, neurological, or respiratory diseases when judged significant
- History of alcohol or drug abuse within 6 months before Day 1
- Current participation in another clinical study or previous enrollment in this study
- Involvement of study staff or relatives in the research
- Prolonged exposure to sheep or goats (e.g., shepherds, sheep farmers)
AI-Screening
AI-Powered Screening
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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
Research Team
U
University Hospital Tübingen
CONTACT
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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