A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine

NCT06147895 | Completed Phase 1

• 1 other identifier: CVI-HBV-002-CT2001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccine-Preventable Diseases; Hepatitis B

Outcome Measures

Primary Outcomes (5)

• Immediate adverse events

  Occurrence of immediate adverse events

  within 30 minutes post vaccination timepoint

• Solicited local and systemic signs and symptoms

  Occurrence, severity, and duration of solicited local injection site reactions for 7 days (Day 0-Day 6) following each vaccination. (e.g., pain in daily activities, redness and swelling in size(cm)) Occurrence, severity, and duration of solicited systemic reactions for 7 days (Day 0-Day 6) following each vaccination. (e.g., myalgia, fatigue and headache in daily activities, fever in oral temperature)

  Time Frame: Day 0 - Day 6 post each vaccination timepoint

• Unsolicited signs and symptoms

  Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following each vaccination

  Day 0-Day 28 post each vaccination timepoint

• SAEs

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity

  Up to Week 48 post the 3rd vaccination

• Safety as measured by clinical laboratory test, vial sign and physical examination parameters

  Occurrence, intensity, and relationship to vaccination of clinically significant adverse events

  Until Week 48 post the 3rd vaccination

Secondary Outcomes (2)

• Seroprotective Immune Response

  Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2

• Measurement of Serum GMT

  Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2

Study Arms (2)

Group 1

EXPERIMENTAL

CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses

Biological: CVI-HBV-002

Group 2

EXPERIMENTAL

CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses

Biological: CVI-HBV-002

Interventions

CVI-HBV-002 BIOLOGICAL

Investigational Product

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Any gender, age 19-64 years
• Those whose anti-HBs titer is less than 10 mIU/mL
• Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form

You may not qualify if:

• Patient with positive test for antibody to hepatitis B core antigen (anti-HBc)
• Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product
• A person who suffered from serious acute or chronic infection within 7 days prior to administration of investigational product (Those who need systemic antibiotic treatment or antiviral therapy)
• In case of immunodeficiency or immune dysfunction, or if there is a family history of such
• Patients with abnormal liver function test results
• Patients with active bacterial, viral or fungal infections requiring systemic treatment
• Patients with a history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring treatment, or unstable angina, etc.)
• Seizure disorders requiring anticonvulsant treatment
• Patients with severe chronic obstructive pulmonary disease accompanied by hypoxemia
• Patients with uncontrolled diabetes
• Patients with uncontrolled hypertension
• Patient with positive test for HBsAg, HIV or Hepatitis C
• Those with hypersensitivity or anaphylactic reaction to HBV vaccine components
• Those who have received immunosuppressive or immunomodulatory drugs within 6 months before screening
• Patients who have received high-dose (20 mg or more per day based on prednisolone\*) systemic corticosteroids for a long period of time (administration for more than 14 consecutive days) within 3 months before screening (in the case of topical corticosteroids, subject to the investigator's judgment)

Sponsors & Collaborators

• CHA Vaccine Institute Co., Ltd.: lead

Study Sites (1)

CHA University Bundang Medical Center

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

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Hepatitis B

Condition Hierarchy (Ancestors)

Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Youngsang Kim

  CHA University Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 28, 2023
• Study Start: September 17, 2021
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: March 25, 2024

Record last verified: 2023-11

Locations

KR (1)