Chronic Hepatitis BPhase 1NCT06162299
A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002
A Phase 1 study testing YS-HBV-002 in people with Chronic Hepatitis B, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in Philippines.
Trial summary
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- YS-HBV-002
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jul 2024to 31 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years during screening
- Body Mass Index (BMI) of 18.5-30 kg/m2
- Diagnosed or laboratory confirmed to have CHB
- Have CHB infection for at least 6 months
- HBsAg titer ≥ 1000 IU/mL
- HBV DNA ≥ 2000 IU/mL
Show all 10Show fewer
- Serum alanine amino transferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN)
- Able to provide informed consent
- Able and willing to comply with all study procedures throughout the study period of approximately 3 months
- For female subjects with childbearing potential: must agree to avoid pregnancy throughout the study period of approximately 3 months. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods on avoiding pregnancy include: a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with a spermicide.
Who cannot join
- Pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial
- Transient elastography at screening revealing a FibroScan value of ≥ 9 kPa or a previous liver biopsy evidencing hepatic fibrosis at or within 24 months prior to vaccination
- Patients with hepatitis caused by other etiologies
- History of or manifestations of liver decompensation (e.g., Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, etc....)
- Currently participating in or has participated in a study with an IP within 30 days preceding Day 0
- Fever (axillary temperature ≥ 37.8 ℃)
Show all 21Show fewer
- Subjects with abnormal indicators of blood biochemistry and other routine blood tests deemed clinically significant by the investigator
- History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema, or allergic abdominal pain) or allergy to any of the components of YS-HBV-002
- Any history of anaphylaxis or angioedema after any vaccination
- Allergy to kanamycin and aminoglycosides
- Past or family history of convulsion, epilepsy, encephalopathy, or mental illness
- Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases
- History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease)
- Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on the investigator's judgement
- Vaccinated with live attenuated vaccine within 1 month, or other vaccine/non-COVID-19 vaccine within 14 days prior to vaccination
- Receiving immunotherapy or inhibitor therapy (consistently oral or infusion for more than 14 days) within 3 months prior to vaccination
- Received systemic immunosuppressants within 4 months prior to vaccination or anticipating the need for immunosuppressant at any time during participation in the study. Topical or inhaled treatment is allowed if not used within 14 days prior to vaccination
- Have received antiviral therapy for chronic hepatitis but have stopped for less than 30 days or plan to take antiviral therapy during the study
- Received blood products within 3 months before vaccine administration
- History of alcohol or drug abuse within the past 2 years
- Any condition that, in the opinion of the investigator, would pose a health risk to the patient if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Randomized, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002 in the Treatment of Chronic Hepatitis B (CHB) Infection in Adults ≥ 18 Years Old
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL.
Read the detailed description
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL. Enrollment in the study will sequentially start from the low dose 0.5mL as Group A, then to the mid-dose 1.0mL as Group B and lastly to the high dose of 2.0mL as Group C. Each group will have 16 patients enrolled. The first 4 enrollees in Group A will be sentinel patients and will be allocated at a 1:1 ratio to receive 0.5mL of either YS-HBV-002 or placebo (Table 3). As there is no comparable equivalent to YS-HBV-002 available in the market, the placebo of normal saline solution to be injected intramuscularly will serve as the control in this trial. The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 0.5mL of either YS-HBV-002 or placebo. The vaccination regimen will be 1 IM injection every 3 days in the deltoid muscle, alternately for approximately 6 weeks. A total of 14 injections will be administered to each patient.
- Conditions
- Chronic Hepatitis B
- Being tested
- YS-HBV-002
- Keywords
- PIKA Adjuvant
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YS-HBV-002Biological
YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Low dose 0.5mL | Experimental | Group A ：The first 4 enrollees in Group A will be sentinel patients and will be allocated at a 1:1 ratio to receive 0.5mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 0.5mL of either YS-HBV-002 or placebo. Receives: Biological: YS-HBV-002 |
| Mid-dose 1.0mL | Experimental | Group B ：The first 4 enrollees in Group B will be sentinel patients and will be allocated at a 1:1 ratio to receive 1.0mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 1.0mL of either YS-HBV-002 or placebo. Receives: Biological: YS-HBV-002 |
| High dose 2.0mL | Experimental | Group C ：The first 4 enrollees in Group C will be sentinel patients and will be allocated at a 1:1 ratio to receive 2.0mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 2.0mL of either YS-HBV-002 or placebo. Receives: Biological: YS-HBV-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs within 30 minutes after vaccination.
To assess the safety and tolerability
Measured: 30 minutes post each vaccination
Incidence of solicited local reactions within 7 days after each vaccination.
To assess the safety and tolerability
Measured: 7 days post each vaccination
Incidence of solicited systemic reactions from first vaccination to 7 days after the last vaccination (D1 to D46).
To assess the safety and tolerability
Measured: From Day1 to Day46
Incidence of unsolicited AEs, serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs), and AEs leading to withdrawals throughout the study period
To assess the safety and tolerability
Measured: From Day1 to Day 90
Secondary outcomes (7)
Proportion of patients showing reduction in HBV DNA using PCR for each dose from baseline to the end of the study and at specified timepoints.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Change in mean log10 of HBV DNA from baseline to end of study and at each specified timepoint.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Change in serum levels of HBeAg, HBcAg, and HBsAg from baseline to end of study at each specified timepoint.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Change in serum levels of HBeAg, HBcAg, and HBsAg from baseline to end of study and at each specified timepoint.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Proportion of patients with loss (defined as lower limit of quantitation [LLOQ]) or decline in HBsAg, HBcAg, and HBeAg from baseline to the end of the study and at each specified timepoint.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
GMTs of antibodies against HBsAg, HBcAg and HBeAg at baseline and at pre-defined post-vaccination timepoints.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Seroconversion rates of antibodies against HBsAg, HBcAg, and HBeAg.
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Measured: Day0， Day16， Day34， Day60， Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Why it stopped: Business strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ike Minerva, MD, Principal investigator, Iloilo Doctors' Hospiyal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162299
- Sponsor's protocol ID
- YS-101
- Status last verified
- Feb 2025
- First submitted
- 22 Nov 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Randomized, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002 in the Treatment of Chronic Hepatitis B (CHB) Infection in Adults ≥ 18 Years Old
- ClinicalTrials.gov ID
- NCT06162299
- Acronym / sponsor ID
- YS-101
- Conditions
- Chronic Hepatitis B
- Keywords
- PIKA Adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business strategy
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Dec 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.
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL.
Detailed description
This is the first-in-human Phase I, double-blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults ≥18 years old. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL. Enrollment in the study will sequentially start from the low dose 0.5mL as Group A, then to the mid-dose 1.0mL as Group B and lastly to the high dose of 2.0mL as Group C. Each group will have 16 patients enrolled. The first 4 enrollees in Group A will be sentinel patients and will be allocated at a 1:1 ratio to receive 0.5mL of either YS-HBV-002 or placebo (Table 3). As there is no comparable equivalent to YS-HBV-002 available in the market, the placebo of normal saline solution to be injected intramuscularly will serve as the control in this trial. The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 0.5mL of either YS-HBV-002 or placebo. The vaccination regimen will be 1 IM injection every 3 days in the deltoid muscle, alternately for approximately 6 weeks. A total of 14 injections will be administered to each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose 0.5mL | Experimental | Biological: YS-HBV-002Group A ：The first 4 enrollees in Group A will be sentinel patients and will be allocated at a 1:1 ratio to receive 0.5mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 0.5mL of either YS-HBV-002 or placebo. |
| Mid-dose 1.0mL | Experimental | Biological: YS-HBV-002Group B ：The first 4 enrollees in Group B will be sentinel patients and will be allocated at a 1:1 ratio to receive 1.0mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 1.0mL of either YS-HBV-002 or placebo. |
| High dose 2.0mL | Experimental | Biological: YS-HBV-002Group C ：The first 4 enrollees in Group C will be sentinel patients and will be allocated at a 1:1 ratio to receive 2.0mL of either YS-HBV-002 or placebo(saline solution), The next 12 enrollees in Group A will be the main patients and will be allocated at 5:1 to receive 2.0mL of either YS-HBV-002 or placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years during screening
- Body Mass Index (BMI) of 18.5-30 kg/m2
- Diagnosed or laboratory confirmed to have CHB
- Able to provide informed consent
- Able and willing to comply with all study procedures throughout the study period of approximately 3 months
Key exclusion criteria (21 listed)
- Pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial
- Transient elastography at screening revealing a FibroScan value of ≥ 9 kPa or a previous liver biopsy evidencing hepatic fibrosis at or within 24 months prior to vaccination
- Patients with hepatitis caused by other etiologies
- History of or manifestations of liver decompensation (e.g., Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, etc....)
- Currently participating in or has participated in a study with an IP within 30 days preceding Day 0
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 |
|---|---|---|
| YS-HBV-002YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant | Biological | High dose 2.0mL, Low dose 0.5mL, Mid-dose 1.0mL |
Primary outcome
Incidence of AEs within 30 minutes after vaccination.
Time frame: 30 minutes post each vaccination
To assess the safety and tolerability
Incidence of solicited local reactions within 7 days after each vaccination.
Time frame: 7 days post each vaccination
To assess the safety and tolerability
Incidence of solicited systemic reactions from first vaccination to 7 days after the last vaccination (D1 to D46).
Time frame: From Day1 to Day46
To assess the safety and tolerability
Incidence of unsolicited AEs, serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs), and AEs leading to withdrawals throughout the study period
Time frame: From Day1 to Day 90
To assess the safety and tolerability
7 secondary outcomes
Proportion of patients showing reduction in HBV DNA using PCR for each dose from baseline to the end of the study and at specified timepoints.
Time frame: Day0， Day16， Day34， Day60， Day90
Change in mean log10 of HBV DNA from baseline to end of study and at each specified timepoint.
Time frame: Day0， Day16， Day34， Day60， Day90
Change in serum levels of HBeAg, HBcAg, and HBsAg from baseline to end of study at each specified timepoint.
Time frame: Day0， Day16， Day34， Day60， Day90
Change in serum levels of HBeAg, HBcAg, and HBsAg from baseline to end of study and at each specified timepoint.
Time frame: Day0， Day16， Day34， Day60， Day90
Proportion of patients with loss (defined as lower limit of quantitation [LLOQ]) or decline in HBsAg, HBcAg, and HBeAg from baseline to the end of the study and at each specified timepoint.
Time frame: Day0， Day16， Day34， Day60， Day90
GMTs of antibodies against HBsAg, HBcAg and HBeAg at baseline and at pre-defined post-vaccination timepoints.
Time frame: Day0， Day16， Day34， Day60， Day90
Seroconversion rates of antibodies against HBsAg, HBcAg, and HBeAg.
Time frame: Day0， Day16， Day34， Day60， Day90
Results and safety
The study was stopped early (reason given: Business strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Ike Minerva, MD principal investigator
Iloilo Doctors' Hospiyal
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 YS-HBV-002 in people with Chronic Hepatitis B, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in Philippines.
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 10 inclusion and 21 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: stopped early, as of the sponsor's last update on 24 Feb 2025. 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 Philippines. 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 was stopped early (reason given: Business strategy). Results are not available in the source record.
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?
Incidence of AEs within 30 minutes after vaccination. (time frame: 30 minutes post each vaccination). The study lists 4 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 24 Feb 2025.