TherVacB_Phase1a: Open Phase 1a Trial to Assess the Safety and Immunogenicity of a Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate in Healthy Volunteers
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
• 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.
• Healthy male and female subjects aged 18-65 years at time of informed consent.
• No clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at screening visit. The following laboratory parameters should be within normal limits: WBC, ANC, platelets. AST and ALT should be ≤ULN, CrCL \>60mL/min and total bilirubin should not exceed 1,5 x ULN. 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.
• Participant may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to participant 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.
• Women of child-bearing potential (WOCBP) only: non-pregnant, non-lactating women with negative pregnancy test.
• WOCBP who agree to comply with the applicable contraceptive requirements of the protocol.