Vaccine-Preventable DiseasesPhase 1CVI-HBV-002NCT06147895
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Prophylactic Hepatitis B Vaccine
A Phase 1 study testing CVI-HBV-002 in people with Vaccine-Preventable Diseases and Hepatitis B, run by Aribio Lab Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine-Preventable Diseases, Hepatitis B
- What is being tested?
- CVI-HBV-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Sep 2021to 25 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any gender, age 19-64 years
- Those whose anti-HBs titer is less than 10 mIU/mL
- Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form
Who cannot join
- Patient with positive test for antibody to hepatitis B core antigen (anti-HBc)
- Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product
- 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)
- In case of immunodeficiency or immune dysfunction, or if there is a family history of such
- Patients with abnormal liver function test results
- Patients with active bacterial, viral or fungal infections requiring systemic treatment
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- 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.)
- Seizure disorders requiring anticonvulsant treatment
- Patients with severe chronic obstructive pulmonary disease accompanied by hypoxemia
- Patients with uncontrolled diabetes
- Patients with uncontrolled hypertension
- Patient with positive test for HBsAg, HIV or Hepatitis C
- Those with hypersensitivity or anaphylactic reaction to HBV vaccine components
- Those who have received immunosuppressive or immunomodulatory drugs within 6 months before screening
- 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
- Patients currently undergoing hemodialysis
- In case of continuous drinking (more than 21 units/week, 1 unit (1 cup) = 10g of pure alcohol) or alcohol dependence
- 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
- 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)
- 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
- Those who may show other serious febrile or systemic reactions
- 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
- Those who are considered difficult to conduct this clinical trial when judged by other investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
About this study
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
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-HBV-002.
Read the 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
- Conditions
- Vaccine-Preventable Diseases, Hepatitis B
- Being tested
- CVI-HBV-002
- Medical subject headings
- Vaccine-Preventable Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVI-HBV-002Biological
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses Receives: Biological: CVI-HBV-002 |
| Group 2 | Experimental | CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses Receives: Biological: CVI-HBV-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate adverse events
Occurrence of immediate adverse events
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Until Week 48 post the 3rd vaccination
Secondary outcomes (2)
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
Measured: 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
Measured: Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start17 Sep 2021
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aribio Lab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youngsang Kim, Principal investigator, CHA University Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147895
- Sponsor's protocol ID
- CVI-HBV-002-CT2001
- Acronym
- CVI-HBV-002
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06147895
- Acronym / sponsor ID
- CVI-HBV-002 / CVI-HBV-002-CT2001
- Conditions
- Vaccine-Preventable Diseases, Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aribio Lab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CVI-HBV-002CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 8 / total 3 doses |
| Group 2 | Experimental | Biological: CVI-HBV-002CVI-HBV-002 1 mL Intramuscular injection at Baseline, Week 4, Week 24 / total 3 doses |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Any gender, age 19-64 years
- Those whose anti-HBs titer is less than 10 mIU/mL
- Those who have voluntarily agreed to participate in this clinical trial and signed the subject consent form
Key exclusion criteria (24 listed)
- Patient with positive test for antibody to hepatitis B core antigen (anti-HBc)
- Acute illness and/or fever (tympanic temperature rises greater than 38 degrees Celsius) within 72 hours before administration of investigational product
- 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)
- In case of immunodeficiency or immune dysfunction, or if there is a family history of such
- Patients with abnormal liver function test results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVI-HBV-002Investigational Product | Biological | Group 1, Group 2 |
Primary outcome
Immediate adverse events
Time frame: within 30 minutes post vaccination timepoint
Occurrence of immediate adverse events
Solicited local and systemic signs and symptoms
Time frame: 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)
Unsolicited signs and symptoms
Time frame: 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
Time frame: 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
Safety as measured by clinical laboratory test, vial sign and physical examination parameters
Time frame: Until Week 48 post the 3rd vaccination
Occurrence, intensity, and relationship to vaccination of clinically significant adverse events
2 secondary outcomes
Seroprotective Immune Response
Time frame: Baseline, Weeks 4, 8, 12 and 56 for Group 1, baseline, Weeks 4, 8, 28 and 72 for Group 2
Measurement of Serum GMT
Time frame: Weeks 4, 8, 12 and 56 for Group 1, Weeks 4, 8, 28 and 72 for Group 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngsang Kim principal investigator
CHA University Bundang Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVI-HBV-002 in people with Vaccine-Preventable Diseases and Hepatitis B, run by Aribio Lab Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate adverse events (time frame: within 30 minutes post vaccination timepoint). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.