Study Details

OVERVIEW

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)

Participation Requirements

Age

18 Years - 65 Years

Sex

All

Healthy Volunteers

Accepts Healthy Volunteers

Medical Condition

Chronic Hepatitis B

Gender

N/A

Date

April 2023 - January 2025

Study Type

Interventional

Study Phase

Phase 1

Product

GS-2829, GS-6779, Placebo for GS-2829, Placebo for GS-6779

Eligibility Information

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.

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.

Locations

Locations (9)

New Zealand Clinical Research (NZCR)

Auckland, New Zealand, 1010

Chia-Yi Christian Hospital

Chiayi City, Taiwan, 60002

St. Martin De Porres Hospital

Chiayi City, Taiwan, 600

E-DA Hospital

Kaohsiung City, Taiwan, 82445

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan, 833

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 807

National Cheng Kung University Hospital

Tainan City, Taiwan, 7428

National Taiwan University Hospital

Taipei City, Taiwan, 100229

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan, 33305

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