Clinical trial NCT06147895: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vaccine-Preventable Diseases
Hepatitis B
Lead sponsor: CHA Vaccine Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Immediate adverse events
timeFrame: within 30 minutes post vaccination timepoint
measure: Solicited local and systemic signs and symptoms
timeFrame: Time Frame: Day 0 - Day 6 post each vaccination timepoint
measure: Unsolicited signs and symptoms
timeFrame: Day 0-Day 28 post each vaccination timepoint
measure: SAEs
timeFrame: Up to Week 48 post the 3rd vaccination
measure: Safety as measured by clinical laboratory test, vial sign and physical examination parameters
timeFrame: Until Week 48 post the 3rd vaccination
Secondary outcomes:
measure: Seroprotective Immune Response
timeFrame: Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2
measure: Measurement of Serum GMT
timeFrame: Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA University Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA University Bundang Medical Center
name: Youngsang Kim
role: PRINCIPAL_INVESTIGATOR
References: