AzTrials
AzTrials

Hepatitis B, ChronicPhase 1/2NCT02693652

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

A Phase 1/2 study testing CVI-HBV-002 in people with Hepatitis B, Chronic, run by Aribio Lab Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 19 to 60 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
CVI-HBV-002
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteSouth Korea
Study dates
28 Oct 2014to 22 Aug 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult between 19 to 60 years of age
  • Chronic hepatitis B carriers (HBsAg positive over 6 months)
  • HBeAg positive patient, or patient who had lost HBeAg during Antiviral drug treatment
  • 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)
  • Patient has low ALT than 1.1 fold of upper limit of normal ALT level at screening
  • Patient is able to provide written informed consent by oneself or legal representative

Who cannot join

  • Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
  • 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)
Show all 35Show fewer
  • 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)
  • 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
  • Patient has history of Interferon treatment
  • Patient is pregnant or breastfeeding or intending to become pregnant during the study
  • Patient has active microbial, viral, or fungal infections in need of systemic treatment
  • Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patient
  • Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
  • 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
  • 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)
  • Patient has history of organ transplantation
  • Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
  • 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.)
  • Patient has seizure disorder required anticonvulsants treatment
  • Uncontrollable diabetic patient (FBS>130mg/dl, HbA1c>7.5%)
  • Uncontrollable hypertension patient (SBP≥140mmHg 또는 DBP≥90mmHg)
  • HCV, HDV, or HIV patient
  • Patient has a plan to participate in other clinical study, or took part in other clinical study within 1 month before enrollment
  • Patient has hypersensitivity or anaphylactic reaction for components of investigational product or HBV vaccine
  • Patient has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
  • Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
  • Patient has potential to severe febrile or systemic reaction
  • Subject unacceptable in this study under the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Bundang CHA General Hospital

    Seongnam-si, Gyeonggi-do, 13496

Other trials in South Korea

About this study

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

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

Read the 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
Being tested
CVI-HBV-002
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVI-HBV-002Biological

    • 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
Study groups in NCT02693652
Study groupRoleWhat they receive
CVI-HBV-002 (20ug, 3 shots)Experimental* HBV surface antigen 20ug/dose * Intramuscular injection at 0, 1, 2 month
Receives: Biological: CVI-HBV-002
CVI-HBV-002 (20ug, 6 shots)Experimental* HBV surface antigen 20ug/dose * Intramuscular injection at 0, 1, 2, 3, 4, 5 month
Receives: Biological: CVI-HBV-002
CVI-HBV-002 (40ug, 3 shots)Experimental* HBV surface antigen 40ug/dose * Intramuscular injection at 0, 1, 2 month
Receives: Biological: CVI-HBV-002
CVI-HBV-002 (40ug, 6 shots)Experimental* HBV surface antigen 40ug/dose * Intramuscular injection at 0, 1, 2, 3, 4, 5 month
Receives: Biological: CVI-HBV-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination

    Occurrence of severe local and/or systemic tolerability signs and symptoms measured for 7 days after each vaccination

    Measured: 7 days after each vaccination

Secondary outcomes (6)

  1. HBeAg loss

    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

    Measured: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)

  2. HBe seroconversion rate

    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

    Measured: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)

  3. HBsAg loss

    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

    Measured: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)

  4. HBsAg seroconversion rate

    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

    Measured: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)

  5. HBV specific T cell immunity

    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

    Measured: at the 3rd month (for 3 shot group) or 6th month (for 6 shot group)

  6. HBV DNA level

    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

    Measured: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2016 (estimated)
  2. Study start28 Oct 2014
  3. Primary completion22 Aug 2017
  4. Study completion22 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02693652
Sponsor's protocol ID
CVI-HBV-002-CT1301
Status last verified
Nov 2023
First submitted
18 Feb 2016
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CVI-HBV-002 in people with Hepatitis B, Chronic, run by Aribio Lab Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02693652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in