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

NCT02693652 | Completed Phase 1

• 1 other identifier: CVI-HBV-002-CT1301
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (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

  7 days after each vaccination

Secondary Outcomes (6)

• HBeAg loss

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

• HBe seroconversion rate

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

• HBsAg loss

  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)

• HBV specific T cell immunity

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

Study Arms (4)

CVI-HBV-002 (20ug, 3 shots)

EXPERIMENTAL

* HBV surface antigen 20ug/dose * Intramuscular injection at 0, 1, 2 month

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

Biological: CVI-HBV-002

CVI-HBV-002 (40ug, 3 shots)

EXPERIMENTAL

* HBV surface antigen 40ug/dose * Intramuscular injection at 0, 1, 2 month

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

Biological: CVI-HBV-002

Interventions

CVI-HBV-002 BIOLOGICAL

* 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

CVI-HBV-002 (20ug, 3 shots); CVI-HBV-002 (20ug, 6 shots); CVI-HBV-002 (40ug, 3 shots); CVI-HBV-002 (40ug, 6 shots)

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• CHA Vaccine Institute Co., Ltd.: lead

Study Sites (1)

Bundang CHA General Hospital

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu-Sung Rim, M.D., Ph.D.

  Bundang CHA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 29, 2016
• Study Start: October 28, 2014
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

KR (1)