TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMichael Hoelscher
About this trial
This study is an open-label, ascending dose phase 1b/2a trial to assess the safety and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
HBsAg positive for ≥ 6 months
Anti-HBs negative
Disqualifiers
Known liver disease other than hepatitis B
Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol
History of hepatocellular carcinoma
Trial design
Design model
Sequential
Treatments tested in this trial
TherVacB (HEPLISAV B +/- HBcoreAg + MVA-HBVac)
Biological/VaccineAdministration of the described combinations via the intramuscular route
TherVacB (2xHEPLISAV B + HBcoreAg + MVA-HBVac)
Biological/VaccineAdministration of the described combinations via the intramuscular route
Treatment groups
81 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Arm A1Experimental treatment 1 intervention
Group B: Arm A2Experimental treatment 1 intervention
Group C: Arm A3Experimental treatment 1 intervention
Group D: Arm A4Experimental treatment 1 intervention
Group E: Arm A5 (Europe)Experimental treatment 1 intervention
Group F: Arm A6 (Tanzania)Experimental treatment 1 intervention
Group G: Arm B1Experimental treatment 1 intervention
Group H: Arm B2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequencies and magnitudes of unsolicited adverse events
Reported numbers and severity grade of unsolicited AEs for 28 days after each vaccination
Time frame
up to day 842
Frequencies and magnitudes of serious adverse events (SAEs) throughout the trial period
Reported numbers and types of SAEs throughout the period of the clinical trial
Time frame
up to day 2243
Frequencies and magnitudes of adverse event of special interest (AESI) and Suspected Unexpected Serious Adverse Reaction (SUSAR) throughout the trial period
Reported numbers and severity grade of AESIs and numbers and types of SUSARs
Time frame
up to day 2244
Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination
Reported numbers and severity of solicited AEs
Time frame
up to day 63Secondary outcomes
1
Frequency of subjects with HBsAg drop below the lower limit of quantification
Determined by an accredited serological immuno-assay
Time frame
2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit).2
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
Determined by an accredited serological immuno-assay
Time frame
2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit3
Frequency of subjects with an induction of anti-HBs titers ≥ 10 IU/L
Determined by an accredited serological immuno-assay
Time frame
2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visit4
Frequency of subjects developing any anti-HBs antibody response
Determined by an accredited serological immuno-assay
Time frame
2 weeks (Day 70), 2 months (Day 112) and 6 months (Day 224) after completion of the vaccination regimen (last study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael Hoelscher
Lead sponsor
Ludwig-Maximilians - University of Munich
Sponsor institution
Institute of Virology Helmholtz Zentrum München Trogerstraße 30 81675 Munich, Germany
Collaborator
Source ClinicalTrials.gov