TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate (NCT06513286) | Clinical Trial Compass
RecruitingPhase 1/2
TherVacB - A Heterologous Protein Prime/MVA Boost Therapeutic Hepatitis B Vaccine Candidate
Germany81 participantsStarted 2025-06-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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:
. 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.
Exclusion criteria
. Known liver disease other than hepatitis B
. Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequencies and magnitudes of unsolicited adverse events
Timeframe: up to day 84
2
Frequencies and magnitudes of serious adverse events (SAEs) throughout the trial period
Timeframe: up to day 224
3
Frequencies and magnitudes of adverse event of special interest (AESI) and Suspected Unexpected Serious Adverse Reaction (SUSAR) throughout the trial period
Timeframe: up to day 224
4
Frequencies and magnitudes of solicited local reactogenicity signs and symptoms within 7 days after each vaccination
Timeframe: up to day 63
5
Frequencies and magnitudes of solicited systemic reactogenicity signs and symptoms within 7 days after each vaccination
Timeframe: up to day 63
6
Frequencies and magnitudes of liver toxicity (ALT flare-ups) stratified by severity throughout the trial period
Timeframe: up to day 224
7
Change from baseline of safety laboratory measurements throughout the trial period
. 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.