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Assessment of the safety and efficacy of a hepatitis B vaccine in adult patients with hepatitis B
EU CTIS ID: 2023-507623-36-00
What this study is testing
To assess safety and tolerability of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine candidate (TherVacB) Safety and tolerability of the vaccine components of the TherVacB vaccination scheme Safety and tolerability of the TherVacB vaccination scheme in terms of liver toxicity
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.
- Provided written informed consent.
- Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria: - HBsAg positive for ≥ 6 months - Anti-HBs negative - HBsAg levels 100-2000 IU/mL - HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months - HBV load < 100 IU/ml at least twice within the last 6 months
- Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.
- 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: - leukocyte count ≥ 2.500/µl - platelet count ≥ 150.000/µl - ALT elevation ≤ 60 U/L - AST should be ≤ 40 U/L - bilirubin should be ≤ ULN - INR should be ≤ ULN - CrCL > 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.
- 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.
You likely can't join if
- Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
- 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.
- Subjects who are known or suspected • not to comply with the clinical trial directives. • not to be reliable or trustworthy. • not 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.
- WOCBP who don’t agree to comply with the applicable contraceptive requirements of the protocol
- History of hepatocellular carcinoma
- Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)
See the full eligibility criteria
Who can join
- Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.
- Provided written informed consent.
- Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria: - HBsAg positive for ≥ 6 months - Anti-HBs negative - HBsAg levels 100-2000 IU/mL - HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months - HBV load < 100 IU/ml at least twice within the last 6 months
- Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.
- 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: - leukocyte count ≥ 2.500/µl - platelet count ≥ 150.000/µl - ALT elevation ≤ 60 U/L - AST should be ≤ 40 U/L - bilirubin should be ≤ ULN - INR should be ≤ ULN - CrCL > 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.
- 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.
- Body mass index 18.5-32.0 kg/m2 and weight >50 kg at screening.
What rules you out
- Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
- 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.
- Subjects who are known or suspected • not to comply with the clinical trial directives. • not to be reliable or trustworthy. • not 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.
- WOCBP who don’t agree to comply with the applicable contraceptive requirements of the protocol
- History of hepatocellular carcinoma
- Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)
- Regular alcohol intake >30 g/d (male), >20 g/d (female) or any other known drug addiction.
- 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).
- 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.
- 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.
- Known liver disease other than hepatitis B
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
- Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination )
- Clinically relevant findings in ECG or significant thromboembolic events in medical history.
- 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.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the first dose of the trial vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years.
- 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.
- Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches.
- Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Tanzania, United Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Tanzania, United Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.