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

NCT04289987 | Completed Phase 2

• 1 other identifier: CVI-HBV-002-CT1901
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Evaluation of Mean Change in HBsAg(log10 IU/mL)

  To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 48 versus Baseline

  at week 48 from baseline

Secondary Outcomes (8)

• Evaluation of Mean changes in serum HBsAg(log 10 IU/mL)

  at week 24 from baseline

• Proportion assessment of Participants With HBsAg loss

  at weeks 24 and 48

• Proportion assessment of Participants With HBsAg seroconversion

  at weeks 24 and 48

• Proportion assessment of Participants With HBeAg loss

  at Weeks 24 and 48

• Proportion assessment of Participants With HBeAg seroconversion

  at weeks 24 and 48

Study Arms (2)

CVI-HBV-002

EXPERIMENTAL

* CVI-HBV-002 1.0mL(20ug/dose) * Intramuscular injection at Baseline, Week 2, 4, 8, 12, 16, 20 / total 7 doses

Biological: CVI-HBV-002

Normal Saline

PLACEBO COMPARATOR

* Normal Saline Choonwae Inj. 1.0 mL * Intramuscular injection at Baseline, Week 2, 4, 8, 12, 16, 20 / total 7 doses

Biological: Normal Saline(placebo)

Interventions

CVI-HBV-002 BIOLOGICAL

Investigational Product

CVI-HBV-002

Normal Saline(placebo) BIOLOGICAL

Investigational Product

Normal Saline

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
• Those who have been diagnosed as chronic hepatitis B patients (e.g.HBsAg positive detected for 6 months or more)
• Started treatment with Tenofovir Disoproxil Fumarate(TDF) or Tenofovir Diproxil(TD), oral HBV antiviral agent, for 6 months to 5 years.
• HBsAg ≥ 100 IU/mL, HBV DNA ≤ 100 IU/mL at screening
• HBV DNA ≤ 2000 IU/mL at screening
• ALT ≤ Upper Limit of Normal) x 2 at screening
• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

You may not qualify if:

• Patients with other hepatic disease other than chronic hepatitis B(e.g., hemochromatosis, Wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis, alpha-1 antitrypsin deficiency, etc)
• If any of the following laboratory tests were found at screening
• Total bilirubin \> Upper Limit of Normal x 2
• Prothrombin time delayed more than 3 seconds than normal
• Serum Albumin \< 30 g/L (3 g/dL)
• Hemoglobin \< 9.0 g/dL eGFR \< 60 mL/min (Cockcroft-Gault)
• Absolute neutrophil count (ANC) \< 1.5 x 10\^9 /L (1500 /mm3)
• Platelet count \< 100 x 10\^9 /L (100 x 10\^3 /mm3)
• Serum creatinine \> 1.5 mg/dL
• Serum amylase \> 2 x ULN and Lipase \> 2 x ULN
• A history of ascites, jaundice, varicoses vein bleeding, hepatic encephalopathy, or other signs of liver failure
• Treated with oral antiviral agents or interferon therapy other than TDF(or TD)
• In case of receiving nephroxic drugs(Aminoglycosides, Amphotericin B, NSAIDs, etc.) within 14 days prior to screening
• When hepatotoxic drugs(Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone, etc.) are administered within 14 days prior to screening
• Patients with active bacterial, viral or fungal infections requiring systemic treatment

Sponsors & Collaborators

• CHA Vaccine Institute Co., Ltd.: lead

Study Sites (9)

Chung-ang University Hospital

Seoul, Dongjak-gu, 06973, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

CHA University Bundang Medical Center

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

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Severance Hospital

Seoul, Sedaemun-gu, 03722, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Soon Chung Hyang University Hospital Seoul

Seoul, Yongsan-gu, 04401, 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

• Joon Hyeok Lee

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 22, 2020
• First Posted: February 28, 2020
• Study Start: February 19, 2020
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

KR (9)