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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05770895




Registration number
NCT05770895
Ethics application status
Date submitted
1/03/2023
Date registered
16/03/2023

Titles & IDs
Public title
Study of HBV Therapeutic Vaccines GS-2829 and GS-6779 in Healthy Participants and Participants With Chronic Hepatitis B
Scientific 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)
Secondary ID [1] 0 0
GS-US-642-5670
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GS-2829
Treatment: Other - GS-6779
Treatment: Other - Placebo for GS-2829
Treatment: Other - Placebo for GS-6779

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

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.

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.

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.

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.

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.

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.


Treatment: Other: GS-2829
Administered intramuscularly

Treatment: Other: GS-6779
Administered intramuscularly

Treatment: Other: Placebo for GS-2829
Administered intramuscularly

Treatment: Other: Placebo for GS-6779
Administered intramuscularly
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Percentage of Participants With Treatment-emergent Laboratory Abnormalities
Timepoint [2] 0 0
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 [1] 0 0
Proportion of Participants With Vaccine-induced Immune Response
Timepoint [1] 0 0
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 [2] 0 0
Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV)
Timepoint [2] 0 0
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
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Taiwan
State/province [2] 0 0
Chiayi City
Country [3] 0 0
Taiwan
State/province [3] 0 0
Kaohsiung City
Country [4] 0 0
Taiwan
State/province [4] 0 0
Kaohsiung
Country [5] 0 0
Taiwan
State/province [5] 0 0
Tainan City
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taipei City
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05770895