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Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

NCT02496897•Altimmune, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects aged 18-65 years.
•2. Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months.
•3. Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening.
•4. HBeAg negative for at least 2 years prior to inclusion in the study.
•5. HBV DNA \<50 IU/mL for ≥ 12 months
•6. ALT/AST ≤ 1.5 x ULN via the local laboratory at the Screening Visit
•7. Able to give written informed consent to participate
•8. Females should fulfil one of the following criteria:
•1. At least one year menopausal
•2. Surgically sterile
+14 more criteria

Exclusion Criteria

•1. Liver disease other than chronic hepatitis B (a diagnosis of steatosis is permitted providing inclusion criterion 6 is met).
•2. Evidence of Liver cirrhosis on Fibroscan screening (Liver cirrhosis is defined as a Fibroscan measurement of \>11.5 KPa), or previous history or evidence of cirrhosis on radiological imaging, Fibroscan or liver biopsy.
•3. Positive serology for HIV-1 or HIV-2 or HCV or HDV antibodies.
•4. Immunodeficient or autoimmune conditions due to disease or medication e.g. systemic steroids within previous 12 weeks. (Topical or inhaled steroids are permissible).
•5. Clinically relevant co-morbidity, e.g. autoimmune disease.
•6. Clinically relevant anaemia or leukopenia in the opinion of the investigator.
•7. Cancer or treatment for cancer within 3 years prior to screening excluding basal cell carcinoma of the skin, which is allowed.
•8. Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds or any of the stated ingredients.
•9. Receipt of any IMP within 90 days prior to screening or currently receiving IMP or intent to receive IMP.
•10. Current substance or alcohol abuse that in the opinion of the Investigator would interfere with compliance or with interpretation of study results.
+5 more criteria

Locations (21)

Pusan National University Busan Hospital

Busan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei University Health System Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Key Dates

Start Date

July 1, 2015

Primary Completion Date

October 13, 2017

Completion Date

June 5, 2018

Last Updated

May 22, 2025

Enrollment

ACTUAL participants

Conditions

Hepatitis B

Interventions

FP-02.2 Vaccine

BIOLOGICAL

Placebo

OTHER

IC31® Adjuvant

OTHER

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

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Hepatitis B Virus Infection

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series