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Trial record 43 of 348 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Altimmune, Inc.
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.
ClinicalTrials.gov Identifier:
NCT02496897
First received: July 6, 2015
Last updated: September 6, 2016
Last verified: September 2016
  Purpose
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. Seventy-two 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.

Condition Intervention Phase
Hepatitis B
Biological: FP-02.2 Vaccine
Other: Placebo
Other: IC31® Adjuvant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Altimmune, Inc.:

Primary Outcome Measures:
  • Safety Adverse Events and Clinical Laboratory Abnormalities [ Time Frame: Throughout the study to day 225 ] [ Designated as safety issue: Yes ]
    Adverse Events and Clinical Laboratory Abnormalities


Secondary Outcome Measures:
  • Immunological Response [ Time Frame: Throughout the study to day 225 ] [ Designated as safety issue: No ]
    IFN-gamma ELISpot assay specific for FP-02.2 peptides using cryopreserved PBMCs


Estimated Enrollment: 60
Study Start Date: July 2015
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP-02.2 Low Dose
A low dose of the FP-02.2 vaccine.
Biological: FP-02.2 Vaccine
Synthetic Peptide Hepatitis B Vaccine
Experimental: FP-02.2 High Dose
A high dose of the FP-02.2 vaccine.
Biological: FP-02.2 Vaccine
Synthetic Peptide Hepatitis B Vaccine
Experimental: FP-02.2 Low Dose with IC31® Adjuvant
A low dose of the FP-02.2 vaccine with IC31® Adjuvant.
Biological: FP-02.2 Vaccine
Synthetic Peptide Hepatitis B Vaccine
Other: IC31® Adjuvant
IC31® Adjuvant
Experimental: FP-02.2 High Dose with IC31® Adjuvant
A high dose of the FP-02.2 vaccine with IC31® Adjuvant.
Biological: FP-02.2 Vaccine
Synthetic Peptide Hepatitis B Vaccine
Other: IC31® Adjuvant
IC31® Adjuvant
Placebo Comparator: Placebo
Placebo component.
Other: Placebo
Placebo
Experimental: IC31® Adjuvant
IC31® Adjuvant alone.
Other: IC31® Adjuvant
IC31® Adjuvant

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 menstral 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02496897

Contacts
Contact: Bertrand Georges, PhD +44(0)2076914908 bgeorges@altimmune.com

Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: David Mutimer, MD, MBBS         
University Hospitals Bristol Recruiting
Bristol, United Kingdom, BS1 3NU
Principal Investigator: Peter Collins         
Pennine Acute Hospitals Recruiting
Greater Manchester, United Kingdom, M8 5RB
Principal Investigator: Andrew Ustianowski         
Barts and The London School of Medicine and Dentistry, Blizzard Institiue Recruiting
London, United Kingdom, E1 2AT
Principal Investigator: Patrick Kennedy, MD         
King's College Hospital Recruiting
London, United Kingdom, E1 2AT
Principal Investigator: Kosh Agarwal, MD, MBBS         
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: William Rosenberg, MBBS         
St. George's Hospital and Medical School Recruiting
London, United Kingdom, SW17 0QT
Principal Investigator: Daniel Forton, MBBS         
Imperial College London - St Mary's Campus Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Mark Thursz, MD         
Queen's Medical Centre, Nottingham Hospital Recruiting
Nottingham, United Kingdom, NG7 2UH
Principal Investigator: Steve Ryder, MBBS         
Bradford Teaching Hospitals, Bradford Royal Infirmary Recruiting
Yorkshire, United Kingdom, BD9 6RJ
Principal Investigator: Sulleman Moreea, FRCS FRCP         
Sponsors and Collaborators
Altimmune, Inc.
Investigators
Principal Investigator: Mark Thursz, MD Imperial College London
  More Information

Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT02496897     History of Changes
Other Study ID Numbers: FP02.2_CS_01 
Study First Received: July 6, 2015
Last Updated: September 6, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016