- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06162299
A Phase I, The Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002
April 2, 2024 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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
48
Phase
- 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
- Name: Maricris Trillana
- Phone Number: +63917 5855628
- Email: maricris.trillana@yishengbio.com
Study Contact Backup
- Name: Renan Lim
- Phone Number: +63 917 897 2958
- Email: renan.lim@yishengbio.com
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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 ℃)
- 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.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant
|
What is the study measuring?
Primary Outcome Measures
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
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.
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 (Estimated)
May 30, 2024
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
May 30, 2025
Study Registration Dates
First Submitted
November 22, 2023
First Submitted That Met QC Criteria
November 30, 2023
First Posted (Actual)
December 8, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Chronic Disease
- Hepatitis B
- Hepatitis
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- YS-101
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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