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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Biological: GS-2829; Biological: Placebo; Biological: GS-6779

Study type: Interventional

Funder types: Industry

Identifiers

NCT05770895

GS-US-642-5670

Details and patient eligibility

About

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

Enrollment: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 electrocardiogram (ECG).

Phase 1a (Healthy Individuals) only:

• Aged 18 through 60 years.
• No prior history of Hepatitis B infection with a negative hepatitis B surface antigen (HBsAg) and Hepatitis B (HBV) core antibody.

Phase 1b (Virally Suppressed chronic hepatitis B (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 kilo pascal (kPa) within 6 months of screening).
• Diagnosed with CHB on suppressive oral antiviral for ≥ 6 months.
• Must have received an approved HBV-active oral antiviral agent for ≥ 6 months prior to screening with HBV DNA below lower limit of quantification (LLOQ) for ≥ 3 months prior to screening and with no plan to stop HBV-active antivirals during the study.

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 (SARs) coronavirus (COV) - 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 8 patient groups

Phase 1a : Cohort 1 (Healthy Participants) : GS-2829 Low Dose (2 injections)

Experimental group

Description:

Healthy participants will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 focus-forming unit (FFU)/mL) or placebo as intramuscular (IM) injection on Days 1 and 57.

Treatment:

Biological: Placebo

Biological: GS-2829

Phase 1a : Cohort 2 (Healthy Participants) : GS-6779 Low Dose (2 injections)

Experimental group

Description:

Healthy participants will receive a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57.

Treatment:

Biological: GS-6779

Biological: Placebo

Phase 1a : Cohort 3 (Healthy Participants) : GS-2829 and GS-6779 Low Dose (2 cycles)

Experimental group

Description:

Healthy participants will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection, on Days 29 and 85.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829

Phase 1a : Cohort 4 (Healthy Participants) : GS-2829 and GS-6779 High Dose (2 cycles)

Experimental group

Description:

Healthy participants will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection, on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection, on Days 29 and 85.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829

Phase 1a : Cohort 8 (Healthy Participants) : GS-2829 and GS-6779 High Dose (3 cycles)

Experimental group

Description:

Healthy participants will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29, 85 and 141.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829

Phase 1b : Cohort 5 (VS Participants with CHB) : GS-2829 and GS-6779 Low Dose (2 cycles)

Experimental group

Description:

Virally suppressed (VS) participants with Chronic Hepatitis B (CHB) will receive a single low dose of GS-2829 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single low dose of GS-6779 (≥ 0.5 x 10\^6 FFU/mL) or placebo as IM injection on Days 29 and 85.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829

Phase 1b : Cohort 6 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (2 cycles)

Experimental group

Description:

VS participants with CHB will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1 and 57; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29 and 85.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829

Phase 1b : Cohort 7 (VS Participants with CHB) : GS-2829 and GS-6779 High Dose (3 cycles)

Experimental group

Description:

VS participants with CHB will receive a single high dose of GS-2829 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 1, 57 and 113; and a single high dose of GS-6779 (≥ 0.5 x 10\^7 FFU/mL) or placebo as IM injection on Days 29, 85 and 141.

Treatment:

Biological: GS-6779

Biological: Placebo

Biological: GS-2829