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Trial record 70 of 373 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2016 by CHA Vaccine Institute Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
CHA Vaccine Institute Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02693652
First received: February 18, 2016
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus carriers

Condition Intervention Phase
Hepatitis B, Chronic Biological: CVI-HBV-002 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Open Labeled Phase I/IIa Study to Evaluate Safety, Tolerability and Efficacy of a Therapeutic Hepatitis B Vaccine in Oral Antiviral Drug-treated Chronic Hepatitis B Virus Carriers

Resource links provided by NLM:


Further study details as provided by CHA Vaccine Institute Co., Ltd.:

Primary Outcome Measures:
  • Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination [ Time Frame: 7 days after each vaccination ]
    Occurrence of severe local and/or systemic tolerability signs and symptoms measured for 7 days after each vaccination


Secondary Outcome Measures:
  • HBeAg loss [ Time Frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) ]
    HBeAg disappearance at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline

  • HBe seroconversion rate [ Time Frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) ]
    HBeAg seroconversion rate at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline

  • HBsAg loss [ Time Frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) ]
    HBsAg disappearance at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline

  • HBsAg seroconversion rate [ Time Frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) ]
    HBsAg seroconversion rate at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline

  • HBV specific T cell immunity [ Time Frame: at the 3rd month (for 3 shot group) or 6th month (for 6 shot group) ]
    HBV specific T cell response at the 3rd month (for 3 shot group) or 6th month (for 6 shot group) comparing with that of baseline

  • HBV DNA level [ Time Frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) ]
    HBV DNA level at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline


Estimated Enrollment: 36
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CVI-HBV-002 (20ug, 3 shots)
  • HBV surface antigen 20ug/dose
  • Intramuscular injection at 0, 1, 2 month
Biological: CVI-HBV-002
  • Investigational product: CVI-HBV-002
  • Dose: 20ug or 40ug
  • Frequency: 3 or 6 times
  • Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
  • Administration route: Intramuscular injection
Experimental: CVI-HBV-002 (20ug, 6 shots)
  • HBV surface antigen 20ug/dose
  • Intramuscular injection at 0, 1, 2, 3, 4, 5 month
Biological: CVI-HBV-002
  • Investigational product: CVI-HBV-002
  • Dose: 20ug or 40ug
  • Frequency: 3 or 6 times
  • Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
  • Administration route: Intramuscular injection
Experimental: CVI-HBV-002 (40ug, 3 shots)
  • HBV surface antigen 40ug/dose
  • Intramuscular injection at 0, 1, 2 month
Biological: CVI-HBV-002
  • Investigational product: CVI-HBV-002
  • Dose: 20ug or 40ug
  • Frequency: 3 or 6 times
  • Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
  • Administration route: Intramuscular injection
Experimental: CVI-HBV-002 (40ug, 6 shots)
  • HBV surface antigen 40ug/dose
  • Intramuscular injection at 0, 1, 2, 3, 4, 5 month
Biological: CVI-HBV-002
  • Investigational product: CVI-HBV-002
  • Dose: 20ug or 40ug
  • Frequency: 3 or 6 times
  • Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
  • Administration route: Intramuscular injection

Detailed Description:
  • Objectives: To explore the appropriate dose of a therapeutic hepatitis B vaccine through the evaluation of safety, tolerability, and efficacy
  • Subjects: Chronic hepatitis B carrier with normal ALT range
  • Study hypothesis: The immune tolerance break and strong immune responses in the chronic hepatitis B carrier could be achieved with therapeutic hepatitis B vaccine containing novel adjuvant
  Eligibility

Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult between 19 to 60 years of age
  2. Chronic hepatitis B carriers (HBsAg positive over 6 months)
  3. HBeAg positive patient, or patient who had lost HBeAg during Antiviral drug treatment
  4. Antiviral drug treated patient reducing the HBV DNA level below 2000 IU/mL measured by COBAS TaqManM HBV Test (Duration of drug administration should be over 6 months and no limitation on the type of antiviral drug)
  5. Patient has low ALT than 1.1 fold of upper limit of normal ALT level at screening
  6. Patient is able to provide written informed consent by oneself or legal representative

Exclusion Criteria:

  1. Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
  2. Patient has one or more test results and symptoms at the screening

    • ALT > upper limit of normal level X 1.1
    • Total bilirubin > upper limit of normal
    • Prothrombin time > Over 3 second than normal
    • Serum Albumin < 30 g/L (3 g/dL)
    • Patient has history of ascites, yellow jaundice, variceal hemorrhage, hepatic encephalopathy, or liver failure
    • Liver FibroScan > F3 (F0: no fibrosis, F1: portal fibrosis, F2: periportal fibrosis, F3: septal fibrosis, F4: cirrhosis)
  3. Patient has one or more test results at the screening

    • Hemoglobin < 9.0 g/dL
    • Absolute neutrophil count (ANC) < 1.5 x 109 /L (1500 /mm3)
    • Platelet count < 100 x 109 /L (100 x 103 /mm3)
    • Serum creatinine > 1.5 mg/dL
    • Serum amylase > 2 x ULN and Lipase > 2 x ULN
  4. Patient has history of Interferon treatment
  5. Patient is pregnant or breastfeeding or intending to become pregnant during the study
  6. Patient has active microbial, viral, or fungal infections in need of systemic treatment
  7. Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patient
  8. Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
  9. Patient had long term systemic treatment (more than 14 days consecutively) of high dose (over 20 mg of prednisolone or equivalent dose*) corticosteroid (Decision to participate of patient who had local treatment of corticosteroid is allowed in the opinion of the investigator)

    *equivalent to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, or betamethasone 2.4 mg

  10. Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient (Benign tumor patient is able to participate in this study at the discretion of the investigator)
  11. Patient has history of organ transplantation
  12. Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
  13. Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
  14. Patient has seizure disorder required anticonvulsants treatment
  15. Uncontrollable diabetic patient (FBS>130mg/dl, HbA1c>7.5%)
  16. Uncontrollable hypertension patient (SBP≥140mmHg 또는 DBP≥90mmHg)
  17. HCV, HDV, or HIV patient
  18. Patient has a plan to participate in other clinical study, or took part in other clinical study within 1 month before enrollment
  19. Patient has hypersensitivity or anaphylactic reaction for components of investigational product or HBV vaccine
  20. Patient has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
  21. Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
  22. Patient has potential to severe febrile or systemic reaction
  23. Subject unacceptable in this study under the opinion of the investigator
  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: NCT02693652

Contacts
Contact: Kyu-Sung Rim, M.D., Ph.D. 82-31-780-5212 ksrimmd@cha.ac.kr
Contact: Hana Park, M.D. 82-30-780-4927 phn223@cha.ac.kr

Locations
Korea, Republic of
Bundang CHA General Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Contact: Kyu-Sung Rim, M.D., Ph.D.    82-31-780-5212    ksrimmd@cha.ac.kr   
Contact: Hana Park, M.D.    82-31-780-4927    phn223@cha.ac.kr   
Sponsors and Collaborators
CHA Vaccine Institute Co., Ltd.
Investigators
Principal Investigator: Kyu-Sung Rim, M.D., Ph.D. Bundang CHA General Hospital
  More Information

Responsible Party: CHA Vaccine Institute Co., Ltd.
ClinicalTrials.gov Identifier: NCT02693652     History of Changes
Other Study ID Numbers: CVI-HBV-002-CT1301
Study First Received: February 18, 2016
Last Updated: February 23, 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 21, 2017