A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine (CVI-HBV-002)

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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Vaccine-Preventable Diseases
• Intervention / Treatment: Biological: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • CHA University Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses	Biological: CVI-HBV-002; Investigational Product
Experimental: Group 2; CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses	Biological: CVI-HBV-002; Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotective Immune Response	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	Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2
Measurement of Serum GMT	Serum GMT of Anti-HBsAg Measured at baseline and at Weeks 4 post each vaccination and at last visit	Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2

Collaborators and Investigators

• Sponsor: CHA Vaccine Institute Co., Ltd.
• Investigators: Principal Investigator: Youngsang Kim, CHA University Bundang Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Vaccine-Preventable Diseases
• Other Study ID Numbers: CVI-HBV-002-CT2001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No