First in Human Study of ChAdOx1-HBV
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Hepatitis B
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The participants will be recruited sequentially in 4 cohorts as follows - Cohort 1 - Healthy Volunteers - Low dose Vaccine - 5 participants Cohort 2 - Healthy Volunteers - High dose Vaccine - 5 participants Cohort 3 - Participants with Chronic Hepatitis B infection - Low dose - 6 participants Cohort 4 - Participants with Chronic Hepatitis B infection - High dose - 6 participantsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine will be given to participants in a dose escalation strategy (two doses). The study aims to recruit first healthy volunteers (n=10) and then adult patients (n=12) who are chronical...
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine will be given to participants in a dose escalation strategy (two doses). The study aims to recruit first healthy volunteers (n=10) and then adult patients (n=12) who are chronically infected with HBV and are treated with anti-viral medication, either tenofovir or entecavir with persistent virological control. Each participant will receive 1 dose of the vaccine (intramuscular injection). Participants (Volunteers & patients) will attend up to 9 study visits in total. The last visit will be 24 weeks after vaccination. The primary endpoint of the study is safety. The secondary endpoint is the assessment of the immune response to hepatitis B that is generated by the vaccine. The study will also determine the effect of ChAdOx1-HBV on virological and immunological systemic and intrahepatic changes in participants with CHB.
Tracking Information
- NCT #
- NCT04297917
- Collaborators
- Not Provided
- Investigators
- Not Provided
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