HealthyPhase 1/2NCT02692170
A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
A Phase 1/2 study testing CVI-HBV-001 and Conventional Hepatitis B vaccine (20 μg) in people with Healthy, run by Aribio Lab Co., Ltd..
Trial summary
A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CVI-HBV-001 and Conventional Hepatitis B vaccine (20 μg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2012to 28 May 2015
- Phase
- Phase 1/2
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 20 and 50 years of age
- Anti-HBs titers < 10 mIU/mL
- Subject is able to provide written informed consent by oneself or legal representative
Who cannot join
- Hepatitis B core antibodies positive patient
- Patient has abnormal results in liver-function test
- Patient has active microbial, viral, or fungal infections in need of systemic treatment
- Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
- Patient has seizure disorder required anticonvulsants treatment
- Serious chronic obstructive pulmonary disease patient accompanied hypoxemia
Show all 16Show fewer
- Uncontrollable diabetic patient
- Uncontrollable hypertension patient
- Patient with known history of HIV, HBV, or HCV infection
- Subject had experience of participating other clinical study or clinical treatment within 30 days before screening
- Subject has hypersensitivity or anaphylactic reaction for HBV vaccine components
- Patient being treated for prolonged immunosuppressive therapy (including steroids)
- Hemodialysis patient
- Subject has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
- Subject is pregnant or breastfeeding or intending to become pregnant during the study
- Subject has any other significant findings unacceptable in this study under the opinion of the investigator
About this study
Official title: A Single Center, Randomized, Double Blinded PhaseI/IIa Exploratory Study to Evaluate Reactogenicity, Safety, Immunogenicity and Dose Response of a New Hepatitis B Vaccine in Human Adult
A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult
Read the detailed description
- Objectives: To explore the most effective dose of the third generation Hepatitis B vaccine through the evaluation of reactogenicity, safety, and immunogenicity.
- Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous injections of the conventional Hepatitis B vaccine.
- Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in addition to S antigen, has an ability to elicit faster protection and higher antibody titers than the second generation Hepatitis B vaccine in the subjects.
- Conditions
- Healthy
- Being tested
- CVI-HBV-001, Conventional Hepatitis B vaccine (20 μg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVI-HBV-001Biological
Investigational Product
Conventional Hepatitis B vaccine (20 μg)Biological
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| CVI-HBV-001 (5 μg) | Experimental | * HBV surface antigen 5 μg/dose
* Intramuscular injection at 0, 1, 6th month Receives: Biological: CVI-HBV-001 |
| CVI-HBV-001 (10 μg) | Experimental | * HBV surface antigen 10 μg/dose
* Intramuscular injection at 0, 1, 6th month Receives: Biological: CVI-HBV-001 |
| CVI-HBV-001 (20 μg) | Experimental | * HBV surface antigen 20 μg/dose
* Intramuscular injection at 0, 1, 6th month Receives: Biological: CVI-HBV-001 |
| CVI-HBV-001 (40 μg) | Experimental | * HBV surface antigen 40 μg/dose
* Intramuscular injection at 0, 1, 6th month Receives: Biological: CVI-HBV-001 |
| Conventional Hepatitis B vaccine (20 μg) | Active comparator | * HBV surface antigen 20 μg/dose
* Intramuscular injection at 0, 1, 6th month Receives: Biological: Conventional Hepatitis B vaccine (20 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
Measured: 7 days after each vaccination
Secondary outcomes (2)
Seroprotection rate
Seroprotection (> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination
Measured: 4 weeks after vaccination
Antibody titers to HBsAg
Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination
Measured: 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start7 Dec 2012
- Primary completion28 May 2015
- Study completion28 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aribio Lab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seong Gyu Hwang, M.D., Ph.D., Principal investigator, Bundang CHA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692170
- Sponsor's protocol ID
- CVI-HBV-001-CT1201
- Status last verified
- Nov 2023
- First submitted
- 18 Feb 2016
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double Blinded PhaseI/IIa Exploratory Study to Evaluate Reactogenicity, Safety, Immunogenicity and Dose Response of a New Hepatitis B Vaccine in Human Adult
- ClinicalTrials.gov ID
- NCT02692170
- Acronym / sponsor ID
- CVI-HBV-001-CT1201
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aribio Lab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2012 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- 28 May 2015 (actual)
- First posted
- 25 Feb 2016 (estimated)
- 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.
A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult
Detailed description
- Objectives: To explore the most effective dose of the third generation Hepatitis B vaccine through the evaluation of reactogenicity, safety, and immunogenicity.
- Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous injections of the conventional Hepatitis B vaccine.
- Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in addition to S antigen, has an ability to elicit faster protection and higher antibody titers than the second generation Hepatitis B vaccine in the subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CVI-HBV-001 (5 μg) | Experimental | Biological: CVI-HBV-001* HBV surface antigen 5 μg/dose * Intramuscular injection at 0, 1, 6th month |
| CVI-HBV-001 (10 μg) | Experimental | Biological: CVI-HBV-001* HBV surface antigen 10 μg/dose * Intramuscular injection at 0, 1, 6th month |
| CVI-HBV-001 (20 μg) | Experimental | Biological: CVI-HBV-001* HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month |
| CVI-HBV-001 (40 μg) | Experimental | Biological: CVI-HBV-001* HBV surface antigen 40 μg/dose * Intramuscular injection at 0, 1, 6th month |
| Conventional Hepatitis B vaccine (20 μg) | Active comparator | Biological: Conventional Hepatitis B vaccine (20 μg)* HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults between 20 and 50 years of age
- Anti-HBs titers < 10 mIU/mL
- Subject is able to provide written informed consent by oneself or legal representative
Key exclusion criteria (16 listed)
- Hepatitis B core antibodies positive patient
- Patient has abnormal results in liver-function test
- Patient has active microbial, viral, or fungal infections in need of systemic treatment
- Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
- Patient has seizure disorder required anticonvulsants treatment
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-001Investigational Product | Biological | CVI-HBV-001 (10 μg), CVI-HBV-001 (20 μg), CVI-HBV-001 (40 μg), CVI-HBV-001 (5 μg) |
| Conventional Hepatitis B vaccine (20 μg)Investigational Product | Biological | Conventional Hepatitis B vaccine (20 μg) |
Primary outcome
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Time frame: 7 days after each vaccination
Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
2 secondary outcomes
Seroprotection rate
Time frame: 4 weeks after vaccination
Antibody titers to HBsAg
Time frame: 4 weeks after vaccination
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 18 Nov 2023.
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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.
Seong Gyu Hwang, M.D., Ph.D. principal investigator
Bundang CHA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CVI-HBV-001 and Conventional Hepatitis B vaccine (20 μg) in people with Healthy, run by Aribio Lab Co., Ltd..
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 16 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination (time frame: 7 days after each vaccination). 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 18 Nov 2023.