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
The clinical trial is divided into two overlapping parts (part I and part II) in 24 healthy male and female subjects aged 18-65 years. Part I (N = 11) Protein prime vaccinations two times (day 0 and 28) and MVA based boost vaccination 1 x (day 56) 3 subjects will be allocated to A0 and receive HEPLISAV B® and a boost with MVA-HBVac high dose 3 subjects will be allocated to B0.1 and receive HEPLISAV B® \& HBcoreAg low dose and a boost with MVA-HBVac low dose 5 subjects will be allocated to B0.2 and receive 2 x HEPLISAV B® \& HBcoreAg medium dose and a boost with MVA-HBVac high dose Part II (N = 13) Protein prime vaccinations two times (day 0 and 28) and MVA based boost with MVA-HBVac high dose on day 56 3 subjects will be allocated to C0.1 and receive HBsAg high dose \& HBcoreAg high dose plus boost 5 subjects will be allocated to C0.2 and receive HBsAg medium dose + adjuvant low dose \& HBcoreAg medium dose plus boost 5 subjects will be allocated to C0.3 and receive HBsAg high dose + adjuvant \&HBcoreAg high dose plus boost
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Administration of the described combinations via the intramuscular route
Administration of the described combinations via the intramuscular route
Bernhard Nocht Centre for Clinical Trials (BNCCT)
Hamburg, Germany
Division of Infectious Diseases and Tropical Medicine, LMU Klinikum
Munich, Germany
occurence of solicited local reactogenicity signs and symptoms (AEs)
numerbers of solicited AEs for 7 days after each vaccination
Time frame: up to day 63
occurence of unsolicited local reactogenicity signs and symptoms
numbers of of unsolicited AEs for 28 days after each vaccination
Time frame: up to day 84
changes of safety laboratory measures
changes of values from safety laboratory measures from baseline
Time frame: up to day 224
nature, frequency and severity of adverse events associated with the vaccine
numbers and severity grade of SAEs throughout the period of the clinical trial
Time frame: up to day 224
Magnitude of anti-HBs antibody responses
determined by an accredited serological immuno-assay
Time frame: day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224
Percentage of participants who seroconvert to anti-HBs (>10 IU/l), anti-HBc or anti-HBs and anti-HBc
determined by an accredited serological immuno-assay
Time frame: day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224
Magnitude of HBV-specific T-cell responses
determined by cytokine release assays
Time frame: day 0,day 7,day 28,day 35,day 56,day 63,day 70,day 84,day 224
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