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

NCT02496897 | Completed Phase 1 Results DMC

• 1 other identifier: FP02.2_CS_01
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 21

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

  Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,

  Throughout the study to Day 85

• Number of Subjects With Local Injection Site Reactions

  Incidence of local injection site reactions occurring up to 7 days after each injection

  Days 1 through 64

Secondary Outcomes (1)

• Immunological Response

  Change from baseline to Day 85

Study Arms (6)

FP-02.2 Low Dose

EXPERIMENTAL

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

Biological: FP-02.2 Vaccine

FP-02.2 High Dose

EXPERIMENTAL

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

Biological: FP-02.2 Vaccine

FP-02.2 Low Dose with IC31® Adjuvant

EXPERIMENTAL

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.

Biological: FP-02.2 Vaccine; Other: IC31® Adjuvant

FP-02.2 High Dose with IC31® Adjuvant

EXPERIMENTAL

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.

Biological: FP-02.2 Vaccine; Other: IC31® Adjuvant

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

IC31® Adjuvant

EXPERIMENTAL

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

Other: IC31® Adjuvant

Interventions

FP-02.2 Vaccine BIOLOGICAL

Synthetic Peptide Hepatitis B Vaccine

FP-02.2 High Dose; FP-02.2 High Dose with IC31® Adjuvant; FP-02.2 Low Dose; FP-02.2 Low Dose with IC31® Adjuvant

Placebo OTHER

Placebo

Placebo

IC31® Adjuvant OTHER

IC31® Adjuvant

FP-02.2 High Dose with IC31® Adjuvant; FP-02.2 Low Dose with IC31® Adjuvant; IC31® Adjuvant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Positive serology for HIV-1 or HIV-2 or HCV or HDV antibodies.
• Immunodeficient or autoimmune conditions due to disease or medication e.g. systemic steroids within previous 12 weeks. (Topical or inhaled steroids are permissible).
• Clinically relevant co-morbidity, e.g. autoimmune disease.
• Clinically relevant anaemia or leukopenia in the opinion of the investigator.
• Cancer or treatment for cancer within 3 years prior to screening excluding basal cell carcinoma of the skin, which is allowed.
• Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds or any of the stated ingredients.
• Receipt of any IMP within 90 days prior to screening or currently receiving IMP or intent to receive IMP.
• Current substance or alcohol abuse that in the opinion of the Investigator would interfere with compliance or with interpretation of study results.
• Any condition that in the opinion of the Investigator might interfere with study objectives.
• Pregnant or breastfeeding.
• 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.
• Administration of live vaccines (such as live influenza vaccinations or live travel vaccinations) from 10 days prior to the screening visit until Day 85.

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (21)

Pusan National University Busan Hospital

Busan, 49241, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Yonsei University Health System Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

Korea University Guro Hospital

Seoul, 152703, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

University Hospitals Bristol

Bristol, BS1 3NU, United Kingdom

Location

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

London, E1 2AT, United Kingdom

Location

King's College Hospital

London, E1 2AT, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

St. George's Hospital and Medical School

London, SW17 0QT, United Kingdom

Location

Imperial College London - St Mary's Campus

London, W2 1NY, United Kingdom

Location

Pennine Acute Hospitals

Manchester, M8 5RB, United Kingdom

Location

Bradford Teaching Hospitals, Bradford Royal Infirmary

North Yorks, BD9 6RJ, United Kingdom

Location

Queen's Medical Centre, Nottingham Hospital

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Stephanie Holland, Clinical Project Manager
• Organization: Altimmune

SHolland@Altimmune.com

240-654-1450

Study Officials

• Mark Thursz, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: October 13, 2017
• Study Completion: June 5, 2018
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Locations

GB (10); KR (11)