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

Phase 1

Completed

• Conditions: Hepatitis B; Vaccine-Preventable Diseases
• Interventions: Biological: CVI-HBV-002

• Registration Number: NCT06147895
• Lead Sponsor: CHA Vaccine Institute Co., Ltd.

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

Study Timeline

• Study Start: 2021-09-17
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-19
• Study First Posted: 2023-11-28
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	CVI-HBV-002	CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses
Group 1	CVI-HBV-002	CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses

Primary Outcome Measures

Name	Time	Method
Immediate adverse events	within 30 minutes post vaccination timepoint	Occurrence of immediate adverse events
Unsolicited signs and symptoms	Day 0-Day 28 post each vaccination timepoint	Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following each vaccination
SAEs	Up to Week 48 post the 3rd vaccination	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
Solicited local and systemic signs and symptoms	Time Frame: Day 0 - Day 6 post each vaccination timepoint	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)
Safety as measured by clinical laboratory test, vial sign and physical examination parameters	Until Week 48 post the 3rd vaccination	Occurrence, intensity, and relationship to vaccination of clinically significant adverse events

Secondary Outcome Measures

Name	Time	Method
Measurement of Serum GMT	Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2	Serum GMT of Anti-HBsAg Measured at baseline and at Weeks 4 post each vaccination and at last visit
Seroprotective Immune Response	Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2	Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at baseline and at Weeks 4 post each vaccination and at last visit

Trial Locations

Locations (1)

CHA University Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of