Actively Recruiting
A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-04-24
24
Participants Needed
2
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor
G
German Center for Infection Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, ascending dose phase 1a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine
CONDITIONS
Official Title
A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Provided written informed consent
- Healthy male or female aged 18 to 65 years
- No significant health problems based on medical history, exam, and lab tests
- White blood cells, neutrophils, platelets, AST, ALT, creatinine clearance, and bilirubin within normal limits
- May use chronic or as needed medications if no added safety risk
- Body mass index between 18.5 and 32.0 kg/m2 and weight over 50 kg
- Women of child-bearing potential must be non-pregnant, non-lactating with negative pregnancy test
- Women of child-bearing potential must agree to contraceptive requirements
You will not qualify if you...
- Received any vaccine within 2 weeks before first vaccination (4 weeks for live vaccines), except required pandemic and influenza vaccines
- Previous hepatitis B vaccination or positive hepatitis B antibody status
- Immunization with poxvirus-based viral vector or monkeypox infection within last 10 years
- Allergy to vaccine components or history of life-threatening vaccine reactions
- History of anaphylaxis to vaccination or allergies worsened by vaccine components
- Previous hepatitis B infection (anti-HBc positive)
- Significant ECG abnormalities or thromboembolic events
- Medical conditions affecting vaccine safety or metabolism
- Immunosuppressive or immunodeficient conditions or cytotoxic therapy in past 5 years
- Chronic or active neurologic disorders including seizures and epilepsy, except febrile seizures in childhood or occasional migraines
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Bernhard Nocht Centre for Clinical Trials (BNCCT)
Hamburg, Germany, 20359
Not Yet Recruiting
2
Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Munich, Germany, 80802
Actively Recruiting
Research Team
M
Marylyn M Addo, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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