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

NCT ID: NCT02496897

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-06-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FP-02.2 Low Dose

A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

FP-02.2 Vaccine

Intervention Type: BIOLOGICAL

Synthetic Peptide Hepatitis B Vaccine

FP-02.2 High Dose

A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

FP-02.2 Vaccine

Intervention Type: BIOLOGICAL

Synthetic Peptide Hepatitis B Vaccine

FP-02.2 Low Dose with IC31® Adjuvant

A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

FP-02.2 Vaccine

Intervention Type: BIOLOGICAL

Synthetic Peptide Hepatitis B Vaccine

IC31® Adjuvant

Intervention Type: OTHER

IC31® Adjuvant

FP-02.2 High Dose with IC31® Adjuvant

A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

FP-02.2 Vaccine

Intervention Type: BIOLOGICAL

Synthetic Peptide Hepatitis B Vaccine

IC31® Adjuvant

Intervention Type: OTHER

IC31® Adjuvant

Placebo

Placebo administered by IM injection on Days 1, 29, and 57.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

IC31® Adjuvant

IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57.

Group Type: EXPERIMENTAL

IC31® Adjuvant

Intervention Type: OTHER

IC31® Adjuvant

Interventions

FP-02.2 Vaccine

Synthetic Peptide Hepatitis B Vaccine

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: OTHER

IC31® Adjuvant

IC31® Adjuvant

Intervention Type: OTHER

Eligibility Criteria

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

3. Same-sex relationship

4. WOCBP not surgically sterilized or with laboratory confirmed menopausal status are required to use a highly effective contraceptive measure with low used dependency from screening until one menstrual cycle after the last dose of IMP (Day 58) such as:

• Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
• Progestogen-only hormonal contraception implants associated with inhibition of ovulation
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised partner - must have had medical assessment of successful surgery.

From screening until one menstrual cycle after the last dose of IMP (day 57).

Subjects who practice true abstinence or who exclusively have same sex partners need not use contraception, provided it is in line with their preferred and usual lifestyle. Periodic abstinence (eg calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Should any such subject stop practicing true abstinence, they must use contraception as described above.

Males should fulfil one of the following criteria:

• Surgically sterile
• Willing to abstain from sexual intercourse or use a reliable form of contraception (e.g. condom), if having sex with a pregnant or non-pregnant woman of childbearing potential, from screening until 3 months after the final dose of IMP.
• Surgically sterilised or post-menopausal female partner or same-sex relationship.

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.

11. Any condition that in the opinion of the Investigator might interfere with study objectives.

12. Pregnant or breastfeeding.

13. Subjects should not have received, during the 6 month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immunoglobulins, interferons, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable).

Immunosuppressive treatment such as azathioprine or mercaptopurine is not permitted 6 months prior to screening.

14. Administration of live vaccines (such as live influenza vaccinations or live travel vaccinations) from 10 days prior to the screening visit until Day 85.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Altimmune, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Thursz, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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

Pusan National University Yangsan Hospital

Yangsan, , South Korea

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, , United Kingdom

University Hospitals Bristol

Bristol, , United Kingdom

Barts and The London School of Medicine and Dentistry, Blizzard Institiue

London, , United Kingdom

King's College Hospital

London, , United Kingdom

Royal Free Hospital

London, , United Kingdom

St. George's Hospital and Medical School

London, , United Kingdom

Imperial College London - St Mary's Campus

London, , United Kingdom

Pennine Acute Hospitals

Manchester, , United Kingdom

Bradford Teaching Hospitals, Bradford Royal Infirmary

North Yorks, , United Kingdom

Queen's Medical Centre, Nottingham Hospital

Nottingham, , United Kingdom

Countries

South Korea; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FP02.2_CS_01

Identifier Type: -

Identifier Source: org_study_id