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

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Biological: FP-02.2 Vaccine; Other: Placebo; Other: IC31® Adjuvant

• Registration Number: NCT02496897
• Lead Sponsor: Altimmune, Inc.

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Primary Completion: 2017-10-13
• Study Completion: 2018-06-05
• Results First Submitted: 2019-03-12
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-05-22
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FP-02.2 Low Dose	FP-02.2 Vaccine	A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 High Dose	FP-02.2 Vaccine	A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Low Dose with IC31® Adjuvant	FP-02.2 Vaccine	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.
FP-02.2 Low Dose with IC31® Adjuvant	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.
FP-02.2 High Dose with IC31® Adjuvant	FP-02.2 Vaccine	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.
FP-02.2 High Dose with IC31® Adjuvant	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.
Placebo	Placebo	Placebo administered by IM injection on Days 1, 29, and 57.
IC31® Adjuvant	IC31® Adjuvant	IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57.
FP-02.2 Low Dose	FP-02.2 Vaccine	A low dose of the FP-02.2 vaccine.
FP-02.2 High Dose with IC31® Adjuvant	IC31® Adjuvant	A high dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 High Dose	FP-02.2 Vaccine	A high dose of the FP-02.2 vaccine.
FP-02.2 Low Dose with IC31® Adjuvant	FP-02.2 Vaccine	A low dose of the FP-02.2 vaccine with IC31® Adjuvant.
FP-02.2 Low Dose with IC31® Adjuvant	IC31® Adjuvant	A low dose of the FP-02.2 vaccine with IC31® Adjuvant.
IC31® Adjuvant	IC31® Adjuvant	IC31® Adjuvant alone.
FP-02.2 High Dose with IC31® Adjuvant	FP-02.2 Vaccine	A high dose of the FP-02.2 vaccine with IC31® Adjuvant.
Placebo	Placebo	Placebo component.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)	Throughout the study to Day 85	Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Number of Subjects With Local Injection Site Reactions	Days 1 through 64	Incidence of local injection site reactions occurring up to 7 days after each injection

Secondary Outcome Measures

Name	Time	Method
Immunological Response	Change from baseline to Day 85	IFN-gamma ELISpot assay specific for FP-02.2 peptides using cryopreserved PBMCs

Trial Locations

Locations (21)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Royal Free Hospital; 🇬🇧 London, United Kingdom

Bradford Teaching Hospitals, Bradford Royal Infirmary; 🇬🇧 North Yorkshire, United Kingdom

Pusan National University Busan Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

University Hospitals Bristol; 🇬🇧 Bristol, United Kingdom

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Barts and The London School of Medicine and Dentistry, Blizzard Institiue; 🇬🇧 London, United Kingdom

St. George's Hospital and Medical School; 🇬🇧 London, United Kingdom

Pennine Acute Hospitals; 🇬🇧 Manchester, United Kingdom

Imperial College London - St Mary's Campus; 🇬🇧 London, United Kingdom

Queen's Medical Centre, Nottingham Hospital; 🇬🇧 Nottingham, United Kingdom

Yonsei University Health System Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of