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

NCT06162299 | Terminated Phase 1

• 1 other identifier: YS-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly: 0.5mL, 1.0mL, and 2.0mL.

Conditions

Chronic Hepatitis B

Keywords

PIKA Adjuvant

Outcome Measures

Primary Outcomes (4)

• Incidence of AEs within 30 minutes after vaccination.

  To assess the safety and tolerability

  30 minutes post each vaccination

• Incidence of solicited local reactions within 7 days after 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).

  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

  To assess the safety and tolerability

  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.

  Day0， Day16， Day34， Day60， Day90

• Change in mean log10 of HBV DNA from baseline to end of study and at each specified timepoint.

  Day0， Day16， Day34， Day60， Day90

• Change in serum levels of HBeAg, HBcAg, and HBsAg from baseline to end of study at each specified timepoint.

  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.

  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.

  Day0， Day16， Day34， Day60， Day90

Study Arms (3)

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.

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.

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.

Biological: YS-HBV-002

Interventions

YS-HBV-002 BIOLOGICAL

YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant

High dose 2.0mL; Low dose 0.5mL; Mid-dose 1.0mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Yisheng Biopharma (Singapore) Pte. Ltd.: lead

Study Sites (1)

Iloilo Doctors' Hospital

Iloilo City, Philippines

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ike Minerva, MD

  Iloilo Doctors' Hospiyal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 8, 2023
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)