A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002

February 20, 2025 updated by: Yisheng Biopharma (Singapore) Pte. Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Philippines
      • Iloilo, Philippines
        • Iloilo Doctors' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years during screening
  2. Body Mass Index (BMI) of 18.5-30 kg/m2

  3. Diagnosed or laboratory confirmed to have CHB

    1. Have CHB infection for at least 6 months
    2. HBsAg titer ≥ 1000 IU/mL
    3. HBV DNA ≥ 2000 IU/mL
    4. Serum alanine amino transferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN)
  4. Able to provide informed consent
  5. Able and willing to comply with all study procedures throughout the study period of approximately 3 months
  6. 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.

Exclusion Criteria:

  1. Pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial
  2. 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
  3. Patients with hepatitis caused by other etiologies
  4. 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....)
  5. Currently participating in or has participated in a study with an IP within 30 days preceding Day 0
  6. Fever (axillary temperature ≥ 37.8 ℃)
  7. Subjects with abnormal indicators of blood biochemistry and other routine blood tests deemed clinically significant by the investigator
  8. 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
  9. Any history of anaphylaxis or angioedema after any vaccination
  10. Allergy to kanamycin and aminoglycosides
  11. Past or family history of convulsion, epilepsy, encephalopathy, or mental illness
  12. Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases
  13. History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease)
  14. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on the investigator's judgement
  15. Vaccinated with live attenuated vaccine within 1 month, or other vaccine/non-COVID-19 vaccine within 14 days prior to vaccination
  16. Receiving immunotherapy or inhibitor therapy (consistently oral or infusion for more than 14 days) within 3 months prior to vaccination
  17. 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
  18. Have received antiviral therapy for chronic hepatitis but have stopped for less than 30 days or plan to take antiviral therapy during the study
  19. Received blood products within 3 months before vaccine administration
  20. History of alcohol or drug abuse within the past 2 years
  21. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dose 0.5mL
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.
Biological: YS-HBV-002
YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant
Experimental: Mid-dose 1.0mL
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.
Biological: YS-HBV-002
YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant
Experimental: High dose 2.0mL
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.
Biological: YS-HBV-002
YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AEs within 30 minutes after vaccination.
Time Frame: 30 minutes post each vaccination
To assess the safety and tolerability
30 minutes post each vaccination
Incidence of solicited local reactions within 7 days after each vaccination.
Time Frame: 7 days post each vaccination
To assess the safety and tolerability
7 days post each vaccination
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
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
Time Frame: From Day1 to Day 90
To assess the safety and tolerability
From Day1 to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
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
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Day0， Day16， Day34， Day60， Day90
Seroconversion rates of antibodies against HBsAg, HBcAg, and HBeAg.
Time Frame: Day0， Day16， Day34， Day60， Day90
To evaluate the preliminary efficacy, immunogenicity and determine the appropriate dose
Day0， Day16， Day34， Day60， Day90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yisheng Biopharma (Singapore) Pte. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ike Minerva, MD, Iloilo Doctors' Hospiyal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YS-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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