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

Hepatitis B Clinical Trial

— CVI-HBV-002  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06147895
• Other study ID #: CVI-HBV-002-CT2001
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2021
• Est. completion date: September 25, 2023

Study information

• Verified date: November 2023
• Source: CHA Vaccine Institute Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• CVI-HBV-002
Investigational Product

Locations

Country	Name	City	State
Korea, Republic of	CHA University Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHA Vaccine Institute Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate adverse events	Occurrence of immediate adverse events	within 30 minutes post vaccination timepoint
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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