Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of Repeated Doses of Nonreplicating Arenavirus Vector Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B (CHB)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05770895
• Other study ID #: GS-US-642-5670
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 3, 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

Phase 1a and 1b:

• Body mass index (BMI) of = 32.0 kg/m^2.

• Non-diabetic without impaired glucose tolerance.

• No evidence of cardiac disease based on 12 lead ECG.

Phase 1a (Healthy Individuals) only:

• Aged 18 through 60 years.

• No history of Hepatitis B infection with a negative Hepatitis B virus (HBV) core Antibody.

Phase 1b (Virally suppressed CHB individuals):

• Aged 18 through 65 years.

• Documented CHB and HBsAg = 5000 IU/mL at screening.

• No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan < 9 kPa within 6 months of screening).

• Diagnosed with chronic hepatitis B on suppressive oral antiviral for = 6 months.

Key Exclusion Criteria:

Phase 1a and 1b:

• Use of any systemic antibiotics within 30 days of screening.

• Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period.

• Receipt of any investigational product within 3 months or vaccine within 3 months of screening (with the exception of influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, which if needed, should be administered at least 14 days before or after an investigational product administration).

• Receipt of immunoglobulin or other blood products within 3 months of screening.

• Positive serum pregnancy test at screening or positive urine pregnancy on Day 1.

• Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).

• Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• GS-2829
Administered intramuscularly
• GS-6779
Administered intramuscularly
• Placebo for GS-2829
Administered intramuscularly
• Placebo for GS-6779
Administered intramuscularly

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research (NZCR)	Auckland
Taiwan	Chia-Yi Christian Hospital	Chiayi City
Taiwan	St. Martin De Porres Hospital	Chiayi City
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City
Taiwan	E-DA Hospital	Kaohsiung City
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

New Zealand,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Primary	Percentage of Participants With Treatment-emergent Laboratory Abnormalities		First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Secondary	Proportion of Participants With Vaccine-induced Immune Response		First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Secondary	Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)		First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)

External Links

•   Gilead Clinical Trials Website