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

Sponsor

Gilead Sciences (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05770895

Collaborator

(none)

Enrollment

Arms

20.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Biological: GS-2829 Biological: GS-6779 Biological: Placebo for GS-2829 Biological: Placebo for GS-6779	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: GS-2829 Dose A or Placebo Healthy participants will receive GS-2829 Dose A or placebo for GS-2829.	Biological: GS-2829 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly
Experimental: Cohort 2: GS-6779 Dose B or Placebo Healthy participants will receive GS-6779 Dose B or placebo for GS-6779.	Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-6779 Administered intramuscularly
Experimental: Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.	Biological: GS-2829 Administered intramuscularly Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly Biological: Placebo for GS-6779 Administered intramuscularly
Experimental: Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.	Biological: GS-2829 Administered intramuscularly Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly Biological: Placebo for GS-6779 Administered intramuscularly
Experimental: Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo Participants with Chronic Hepatitis B (CHB) who are virally suppressed will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.	Biological: GS-2829 Administered intramuscularly Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly
Experimental: Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Participants with Chronic Hepatitis B (CHB) who are virally suppressed will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.	Biological: GS-2829 Administered intramuscularly Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly Biological: Placebo for GS-6779 Administered intramuscularly
Experimental: Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo Participants with CHB who are viremic will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.	Biological: GS-2829 Administered intramuscularly Biological: GS-6779 Administered intramuscularly Biological: Placebo for GS-2829 Administered intramuscularly Biological: Placebo for GS-6779 Administered intramuscularly

Outcome Measures

Primary Outcome Measures

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 253 for Cohorts 3 through 7)]
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 253 for Cohorts 3 through 7)]

Secondary Outcome Measures

Proportion of Participants With Vaccine-induced Immune Response [Up to Day 225 for Cohorts 1 and 2; Up to Day 253 for Cohorts 3 through 7]
Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV) [Up to Day 225 for Cohorts 1 and 2; Up to Day 253 for Cohorts 3 through 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Ph1a (Healthy Individuals) Only:

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

Ph1b (CHB Individuals):

Documented CHB and HBsAg <5,000 IU/mL at screening.
No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan < 9 kPa within 6 months of screening).

Only Suppressed Individuals (Cohorts 5 and 6):

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

Only Viremic Individuals (Cohort 7):

Viremic HBV individuals with HBV DNA > lower limit of quantification (LLOQ), and not currently receiving or having received any HBV-active oral antiviral agent for at least 6 months.

Key Exclusion Criteria:

Phase 1A and 1b:

Use of any 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT05770895

Other Study ID Numbers:

GS-US-642-5670

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 16, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023