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

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GS-2829
GS-6779
Placebo for GS-2829
Placebo for GS-6779
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New Zealand Clinical Research (NZCR)Recruiting
  • Chia-Yi Christian HospitalRecruiting
  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationRecruiting
  • E-DA HospitalRecruiting
  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Kaohsiung Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Chang Gung Medical Foundation Linkou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1: GS-2829 Dose A or Placebo

Cohort 2: GS-6779 Dose B or Placebo

Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo

Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo

Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo

Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo

Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo

Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo

Arm Description

Healthy participants will receive GS-2829 Dose A or placebo for GS-2829.

Healthy participants will receive GS-6779 Dose B or placebo for GS-6779.

Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.

Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.

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.

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.

Participants with 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.

Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants With Treatment-emergent Laboratory Abnormalities

Secondary Outcome Measures

Proportion of Participants With Vaccine-induced Immune Response
Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)

Full Information

First Posted
March 1, 2023
Last Updated
October 10, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05770895
Brief Title
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: GS-2829 Dose A or Placebo
Arm Type
Experimental
Arm Description
Healthy participants will receive GS-2829 Dose A or placebo for GS-2829.
Arm Title
Cohort 2: GS-6779 Dose B or Placebo
Arm Type
Experimental
Arm Description
Healthy participants will receive GS-6779 Dose B or placebo for GS-6779.
Arm Title
Cohort 3: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo
Arm Type
Experimental
Arm Description
Healthy participants will receive GS-2829 Dose A or placebo for GS-2829 and GS-6779 Dose B or placebo for GS-6779.
Arm Title
Cohort 4: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo
Arm Type
Experimental
Arm Description
Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.
Arm Title
Cohort 5: GS-2829 Dose A or Placebo + GS-6779 Dose B or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 6: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo
Arm Type
Experimental
Arm Description
Participants with 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.
Arm Title
Cohort 8: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo
Arm Type
Experimental
Arm Description
Healthy participants will receive GS-2829 Dose C or placebo for GS-2829 and GS-6779 Dose D or placebo for GS-6779.
Intervention Type
Biological
Intervention Name(s)
GS-2829
Intervention Description
Administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
GS-6779
Intervention Description
Administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Placebo for GS-2829
Intervention Description
Administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Placebo for GS-6779
Intervention Description
Administered intramuscularly
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
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)
Title
Percentage of Participants With Treatment-emergent Laboratory Abnormalities
Time Frame
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 Outcome Measure Information:
Title
Proportion of Participants With Vaccine-induced Immune Response
Time Frame
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)
Title
Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
New Zealand Clinical Research (NZCR)
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Chia-Yi Christian Hospital
City
Chia-Yi
ZIP/Postal Code
60002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Chia-Yi
ZIP/Postal Code
622
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
E-DA Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung Hsien
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
7428
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100229
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-642-5670
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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