Clinical trial • Phase I • Infectious Disease
AVX37-102 (therapeutic hepatitis B virus vaccine) for Hepatitis B | Chronic hepatitis B
Phase I trial of AVX37-102 (therapeutic hepatitis B virus vaccine) for Hepatitis B | Chronic hepatitis B. 16 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Hepatitis B | Chronic hepatitis B
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 25-02-2025
- First CTIS Authorization Date
- 28-04-2025
Trial design
Phase I trial across 1 site in Belgium.
- Target Sample Size
- 16
- Trial Duration For Participant
- 475
Eligibility
Recruits 16 Vulnerable population not selected; trial population described as healthy adult volunteers; no specific consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; trial population described as healthy adult volunteers; no specific consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 16
- Recruitment Window Months
- 15
- Consent Approach
- Informed consent approach not detailed in the record; trial involves healthy adult volunteers and no assent or paediatric consent procedures are described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 16
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-03-2025
- Latest Decision Or Authorization Date
- 28-04-2025
- Processing Time Days
- 41
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Center for Vaccinology (CEVAC)
- Principal Investigator Name
- Isabel Leroux-Roels
- Principal Investigator Email
- isabel.lerouxroels@uzgent.be
- Contact Person Name
- Isabel Leroux-Roels
- Contact Person Email
- isabel.lerouxroels@uzgent.be
- Number Of Participants
- 16
Sponsor
Primary sponsor
- Full Name
- AstriVax
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- AVX37-102 (therapeutic hepatitis B virus vaccine)
- Modality
- Vaccine
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