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

• Sponsor: CHA Vaccine Institute Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06147895
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaccine-Preventable Diseases; Hepatitis B	Biological: CVI-HBV-002	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Aug 30, 2021
• Actual Primary Completion Date: Sep 25, 2023
• Actual Study Completion Date: Sep 25, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Immediate adverse events [within 30 minutes post vaccination timepoint]

   Occurrence of immediate adverse events

2. 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)

3. 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

4. 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

5. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. Patients currently undergoing hemodialysis

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

3. 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

4. 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)

5. 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

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

7. 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA University Bundang Medical Center	Seongnam-si	Gyeonggi-do	Korea, Republic of	13496

Sponsors and Collaborators

• CHA Vaccine Institute Co., Ltd.

Investigators

• Principal Investigator: Youngsang Kim, CHA University Bundang Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHA Vaccine Institute Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06147895
• Other Study ID Numbers: CVI-HBV-002-CT2001
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Vaccine-Preventable Diseases; Hepatitis

Study Results

No Results Posted as of Nov 28, 2023