At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
HBVaxPro +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
In Brief
A Phase 1 clinical trial evaluating HBVaxPro and HBAI20 for Hepatitis B. Completed, enrolled 34 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether the HBAI20 vaccine is safe and more immunogenic than the HBVaxPro-10µg in people who have never been vaccinated with a hepatitis B vaccine and in people who have been vaccinated 6 times with hepatitis B vaccine but do not have a protective anti hepatitis B antibody titer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesNetherlands
CollaboratorsCyTuVax
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionJul 2016
TodayJul 2026
First PostedSep 4, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.8 years ago
Interventions
HBVaxProbiological
3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.
HBAI20biological
2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days.