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

NCT ID: NCT06147895

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2023-09-25

Brief Summary

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

Detailed Description

A Randomized, Open-labelled, Parallel, Phase 1 clinical study to evaluate the safety, reactogenicity and immunogenicity of the hepatitis B vaccine CVI-HBV-002 in adults

Conditions

Vaccine-Preventable Diseases; Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

CVI-HBV-002

Intervention Type: BIOLOGICAL

Investigational Product

Group 2

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

Group Type: EXPERIMENTAL

CVI-HBV-002

Intervention Type: BIOLOGICAL

Investigational Product

Interventions

CVI-HBV-002

Investigational Product

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Any gender, age 19-64 years

2. Those whose anti-HBs titer is less than 10 mIU/mL

3. Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form

Exclusion Criteria

1. Patient with positive test for antibody to hepatitis B core antigen (anti-HBc)

2. Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product

3. 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)

4. In case of immunodeficiency or immune dysfunction, or if there is a family history of such

5. Patients with abnormal liver function test results

6. Patients with active bacterial, viral or fungal infections requiring systemic treatment

7. 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.)

8. Seizure disorders requiring anticonvulsant treatment

9. Patients with severe chronic obstructive pulmonary disease accompanied by hypoxemia

10. Patients with uncontrolled diabetes

11. Patients with uncontrolled hypertension

12. Patient with positive test for HBsAg, HIV or Hepatitis C

13. Those with hypersensitivity or anaphylactic reaction to HBV vaccine components

14. Those who have received immunosuppressive or immunomodulatory drugs within 6 months before screening

15. 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)

• Equivalent to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg

16. Patients currently undergoing hemodialysis

17. In case of continuous drinking (more than 21 units/week, 1 unit (1 cup) = 10g of pure alcohol) or alcohol dependence

18. In addition to the above, those who have clinically significant findings that are considered inappropriate for this study based on medical judgment by the principal investigator or person in charge

19. Pregnant or lactating women or self- and partner contraception during clinical trials (e.g., sterilization, intrauterine contraceptives, oral contraceptives in combination with interstitial barrier contraception, other hormone delivery systems in combination with interstitial barrier contraception, contraceptive cream, jelly or foam) Persons who cannot agree on diaphragms or condoms)

20. Patients who are concerned about the decline in daily function due to mental illness or who cannot understand the purpose and method of this clinical trial

21. Those who may show other serious febrile or systemic reactions

22. Those who are scheduled to participate in other clinical trials after being enrolled in this clinical trial, or who have participated in other clinical trials within 3 months before being enrolled in this clinical trial

23. Those who are considered difficult to conduct this clinical trial when judged by other investigators

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHA Vaccine Institute Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youngsang Kim

Role: PRINCIPAL_INVESTIGATOR

CHA University Bundang Medical Center

Locations

CHA University Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

CVI-HBV-002-CT2001

Identifier Type: -

Identifier Source: org_study_id