Clinical trial NCT05770895: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-03-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Percentage of Participants With Treatment-emergent Laboratory Abnormalities
timeFrame: 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 outcomes:
measure: Proportion of Participants With Vaccine-induced Immune Response
timeFrame: 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)
measure: Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)
timeFrame: 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)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research (NZCR)
city: Chiayi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Chiayi City
country: Taiwan
facility: St. Martin De Porres Hospital
city: Kaohsiung City
country: Taiwan
facility: E-DA Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: