TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate

Launched by MICHAEL HOELSCHER · Jul 17, 2024

Keywords

ClinConnect Summary

The TherVacB clinical trial is studying a new hepatitis B vaccine designed for people with chronic hepatitis B (CHB) who are already receiving treatment to keep the virus under control. This trial is in its early phase, meaning researchers are primarily focused on understanding how safe the vaccine is and how well it helps the immune system fight the virus. The trial is not yet recruiting participants, but when it does, it will include men and women aged 18 to 70 who have been diagnosed with chronic hepatitis B for at least six months and have stable health aside from their liver condition.

To be eligible, participants will need to understand the study and give their written consent. They'll also need to have specific test results that show they have chronic hepatitis B but are responding well to their current treatment. During the trial, participants can expect to receive the experimental vaccine and will be monitored by healthcare professionals for any side effects or reactions. It’s important for potential participants to be aware that they cannot have other significant liver diseases or certain health conditions that could complicate their participation. Overall, this trial aims to explore a promising new option for managing chronic hepatitis B, with hopes of improving outcomes for those affected by this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.
• • 2. Provided written informed consent.
• 3. 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
• • 4. Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.
• 5. 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.
• • 6. 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.
• • 7. Body mass index 18.5-32.0 kg/m2 and weight \>50 kg at screening.
• Exclusion Criteria:
• • 1. Known liver disease other than hepatitis B
• • 2. Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
• • 3. WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol
• • 4. History of hepatocellular carcinoma
• • 5. Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)
• • 6. Regular alcohol intake \>30 g/d (male), \>20 g/d (female) or any other known drug addiction.
• • 7. 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).
• • 8. 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.
• • 9. Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination)
• • 10. 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.
• • 11. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
• • 12. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
• • 13. 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.
• • 14. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the first dose of the trial vaccine.
• • 15. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years.
• • 16. 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.
• • 17. Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches.
• • 18. Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP.
• • 19. 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.
• • 20. 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.