MOSAIC HBCOREAG for Chronic hepatitis B

Inclusion criteria

• {"criterion_text":"-Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial."}
• {"criterion_text":"-Provided written informed consent."}
• {"criterion_text":"-Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria: -\tHBsAg positive for ≥ 6 months -\tAnti-HBs negative -\tHBsAg levels 100-2000 IU/mL -\tHBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months -\tHBV load < 100 IU/ml at least twice within the last 6 months"}
• {"criterion_text":"-Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent."}
• {"criterion_text":"-Apart from CHB no other clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at the screening visit. The following abnormal laboratory parameters will be permitted: -\tleukocyte count ≥ 2.500/µl -\tplatelet count ≥ 150.000/µl -\tALT elevation ≤ 60 U/L -\tAST should be ≤ 40 U/L -\tbilirubin should be ≤ ULN -\tINR should be ≤ ULN -\tCrCL > 60mL/min. Non-clinically significant, minor deviations of laboratory measurements can be tolerated as they will not increase the risk of the individual having an adverse outcome from participating in this clinical trial as judged by the investigator."}
• {"criterion_text":"-Subject may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition."}
• {"criterion_text":"-Body mass index 18.5-32.0 kg/m2 and weight >50 kg at screening."}

Exclusion criteria

• {"criterion_text":"-Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)"}
• {"criterion_text":"-Investigator or employee of the study site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study."}
• {"criterion_text":"-Subjects who are known or suspected •\tnot to comply with the clinical trial directives. •\tnot to be reliable or trustworthy. •\tnot to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed."}
• {"criterion_text":"-WOCBP who don’t agree to comply with the applicable contraceptive requirements of the protocol"}
• {"criterion_text":"-History of hepatocellular carcinoma"}
• {"criterion_text":"-Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)"}
• {"criterion_text":"-Regular alcohol intake >30 g/d (male), >20 g/d (female) or any other known drug addiction."}
• {"criterion_text":"-Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to receiving the first dose of the investigational medicinal product (IMP)."}
• {"criterion_text":"-Receipt of any vaccine in the 2 weeks prior to first trial vaccination (4 weeks for live vaccines), during trial or planned receipt of any vaccine in the 3 weeks following last trial vaccination. Exception: Required recommended pandemic vaccines or emergency vaccines (e.g., tetanus) are allowed."}
• {"criterion_text":"-Known allergy to components of the vaccine products as referred in Table 6 (incl. hypersensitivity to yeast components, E.coli proteins or lipids, duck’s or hen’s egg white, penicillin, streptomycin, kanamycin) or history of life-threatening reactions to vaccines containing one of the substances."}
• {"criterion_text":"-Known liver disease other than hepatitis B"}
• {"criterion_text":"-Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines."}
• {"criterion_text":"-Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination )"}
• {"criterion_text":"-Clinically relevant findings in ECG or significant thromboembolic events in medical history."}
• {"criterion_text":"-Evidence for a condition in the subject’s medical history or during medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of vaccine products."}
• {"criterion_text":"-Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the first dose of the trial vaccine."}
• {"criterion_text":"-Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years."}
• {"criterion_text":"-Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to systemic corticosteroids, biologicals and Methotrexate) within the last 3 years. Exception: topical corticosteroids, e.g. occasional asthma spays or systemic corticosteroids for medical emergencies."}
• {"criterion_text":"-Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches."}
• {"criterion_text":"-Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP."}

Primary endpoints

• {"endpoint_text":"-Frequencies and magnitudes of unsolicited adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequencies and magnitudes of serious adverse events (SAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequencies and magnitudes of adverse events of special interest (AESI) and Suspected Unexpected Serious Adverse Reactions (SUSAR)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination","definition_or_measurement_approach":"Solicited local reactogenicity signs and symptoms recorded within 7 days after each vaccination."}
• {"endpoint_text":"-Frequencies and magnitudes of solicited systemic reactogenicity signs and symptoms within 7 days after each vaccination","definition_or_measurement_approach":"Solicited systemic reactogenicity signs and symptoms recorded within 7 days after each vaccination."}
• {"endpoint_text":"-Frequencies and magnitudes of liver toxicity (ALT flare-ups) stratified by severity","definition_or_measurement_approach":""}
• {"endpoint_text":"-Change from baseline of safety laboratory measurements","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Frequency of subjects with HBsAg drop below the lower limit of quantification","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequency of subjects with a ≥ 1 log10 drop in HBsAg titers from day 0 (start of study medication) with the goal of 30% of patients achieving a ≥ 1log10 HBsAg drop","definition_or_measurement_approach":"Change from day 0 HBsAg titers; goal stated (30% achieving ≥1 log10 drop)."}
• {"endpoint_text":"-Frequency of subjects with an induction of anti-HBs titers ≥10 IU/L","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequency of subjects developing any anti-HBs antibody response","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequency of subjects with an increased signal in the HBV-specific cytokine-secretion assay compared to pretreatment values","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequency of subjects with an increased frequency of total HBV-specific, cytokine-secreting T cells compared to pretreatment values","definition_or_measurement_approach":""}
• {"endpoint_text":"-Frequency of subjects developing an immune response to TherVacB treatment arms A5, A6 or B4 with the goal of ≥ 30% of patients developing anti-HBs antibody or T-cell responses","definition_or_measurement_approach":"Assessment specific to arms A5, A6, B4; goal ≥30% achieving antibody or T-cell responses."}

Germany

Earliest CTIS Part Ii Submission Date

16-04-2024

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

652

Number Of Sites

6

Number Of Participants

59

Primary sponsor

Full Name

Klinikum der Universitaet Muenchen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"SocraTec R&D Concepts in Drug Research and Development GmbH","duties_or_roles":"codes: 1,5","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Institute of Virology, Immune Monitoring Unit Helmholtz Zentrum München (HMGU)","duties_or_roles":"code: 4","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Institute of Virology, Diagnostics Division Technical University of Munich (TUM)","duties_or_roles":"code: 4","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"SocraMetrics GmbH","duties_or_roles":"codes: 10,6","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Klinikum der Universitaet Muenchen AöR (sponsor third party entry)","duties_or_roles":"code: 8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Universitätsklinikum Leipzig Apotheke","duties_or_roles":"code: 15 (IMP handling)","organisation_type":"Health care"}