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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05770895
Recruitment Status : Active, not recruiting
First Posted : March 16, 2023
Last Update Posted : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 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)
Actual Study Start Date : April 3, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

Biological: Placebo for GS-6779
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 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 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.
 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
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Primary Outcome Measures :
  1. 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) ]
  2. 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 Measures :
  1. 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) ]
  2. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05770895


Locations
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New Zealand
New Zealand Clinical Research (NZCR)
Auckland, New Zealand, 1010
Taiwan
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
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05770895    
Other Study ID Numbers: GS-US-642-5670
First Posted: March 16, 2023    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Chronic Disease
Disease Attributes
Pathologic Processes