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

NCT02496897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-05-22

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

FP-02.2 Vaccine

Synthetic Peptide Hepatitis B Vaccine

OTHER

Placebo

Placebo

OTHER

IC31® Adjuvant

IC31® Adjuvant

Sponsors & Collaborators

  • Altimmune, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Thursz, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-10-13
Completion
2018-06-05

Countries

  • South Korea
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02496897 on ClinicalTrials.gov