NCT02496897

Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. HBeAg-negative subjects will be randomized to receive low or high dose vaccine, in the presence or absence of IC31® adjuvant, or to receive placebo or IC31® adjuvant alone.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	FP-02.2 Vaccine	Synthetic Peptide Hepatitis B Vaccine
OTHER	Placebo	Placebo
OTHER	IC31® Adjuvant	IC31® Adjuvant

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-10-13
• Completion: 2018-06-05
• First posted: 2015-07-14
• Last updated: 2025-05-22
• Results posted: 2025-05-22

Locations

21 sites across 2 countries: South Korea, United Kingdom