At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 61 enrolled
Drug / intervention
FP-02.2 Vaccine +2 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.
A Phase I, Randomized, Double-blind, Placebo-controlled, Multi-centre, Ascending-dose Trial to Evaluate the Safety, Tolerability and Immunogenicity of Vaccine FP-02.2 in HBeAg-negative Hepatitis B Patients as an add-on Treatment to Entecavir or Tenofovir.
In Brief
A Phase 1 clinical trial evaluating FP-02.2 Vaccine, Placebo, and 1 other intervention for Hepatitis B. Completed, enrolled 61 participants across 21 sites in 2 countries.
Detailed Summary
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesSouth Korea, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionOct 2017
Study CompletionJun 2018
TodayJul 2026
First PostedJul 14, 2015
Enrollment StartJul 1, 2015
Primary CompletionOct 13, 2017
Study CompletionJun 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.0 years ago
Interventions
FP-02.2 Vaccinebiological
Synthetic Peptide Hepatitis B Vaccine
Placeboother
Placebo
IC31® Adjuvantother
IC31® Adjuvant