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

• ClinicalTrials.gov Identifier: NCT05770895
• Recruitment Status: Active, not recruiting
• First Posted: March 16, 2023
• Last Update Posted: April 4, 2024
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Tracking Information

• First Submitted Date: March 1, 2023
• First Posted Date: March 16, 2023
• Last Update Posted Date: April 4, 2024
• Actual Study Start Date: April 3, 2023
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2023)

• 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) ]
• 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) ]

Original Primary Outcome Measures (submitted: March 14, 2023)

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

Current Secondary Outcome Measures (submitted: October 10, 2023)

• 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) ]
• 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) ]

Original Secondary Outcome Measures (submitted: March 14, 2023)

• Proportion of Participants With Vaccine-induced Immune Response [ Time Frame: 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) [ Time Frame: Up to Day 225 for Cohorts 1 and 2; Up to Day 253 for Cohorts 3 through 7 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Hepatitis B

Intervention

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

Study Arms

• Experimental: Cohort 1: GS-2829 Dose A or Placebo
  Healthy participants will receive GS-2829 Dose A or placebo for GS-2829.
  Interventions:

  • Biological: GS-2829
  • Biological: Placebo for GS-2829
• Experimental: Cohort 2: GS-6779 Dose B or Placebo
  Healthy participants will receive GS-6779 Dose B or placebo for GS-6779.
  Interventions:

  • Biological: GS-6779
  • Biological: Placebo for GS-6779
• 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.
  Interventions:

  • Biological: GS-2829
  • Biological: GS-6779
  • Biological: Placebo for GS-2829
  • Biological: Placebo for GS-6779
• 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.
  Interventions:

  • Biological: GS-2829
  • Biological: GS-6779
  • Biological: Placebo for GS-2829
  • Biological: Placebo for GS-6779
• 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.
  Interventions:

  • Biological: GS-2829
  • Biological: GS-6779
  • Biological: Placebo for GS-2829
  • Biological: Placebo for GS-6779
• 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.
  Interventions:

  • Biological: GS-2829
  • Biological: GS-6779
  • Biological: Placebo for GS-2829
  • Biological: Placebo for GS-6779
• Experimental: Cohort 7: GS-2829 Dose C or Placebo + GS-6779 Dose D or Placebo
  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.
  Interventions:

  • Biological: GS-2829
  • Biological: GS-6779
  • Biological: Placebo for GS-2829
  • Biological: Placebo for GS-6779
• Experimental: Cohort 8: 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.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 3, 2024): 83
• Original Estimated Enrollment (submitted: March 14, 2023): 70
• Estimated Study Completion Date: January 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: New Zealand, Taiwan

Administrative Information

• NCT Number: NCT05770895
• Other Study ID Numbers: GS-US-642-5670
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gilead Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Gilead Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

• PRS Account: Gilead Sciences
• Verification Date: April 2024