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Trial registered on ANZCTR


Registration number
ACTRN12619001210167
Ethics application status
Approved
Date submitted
9/07/2019
Date registered
30/08/2019
Date last updated
3/05/2021
Date data sharing statement initially provided
30/08/2019
Date results information initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among
Subjects with Chronic Hepatitis B
Scientific title
A Phase Ib/IIa Randomized, Controlled Dose Escalation Study to Evaluate
Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among
Subjects with Chronic Hepatitis B
Secondary ID [1] 298651 0
BRII-179-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B virus (HBV) infection 313541 0
Condition category
Condition code
Infection 311971 311971 0 0
Other infectious diseases
Oral and Gastrointestinal 311972 311972 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
A qualified study site staff member under the supervision of the investigator of designee will administer study drug to participants via IM injection.
Cohort A will serve as the control.
Cohort B participants will receive an intramuscular (IM) injection of 20 microgram BRII-179 (VBI- 2601) per dose on Day 1, Week 4, Week 8 and Week 12
Cohort C participants will receive an IM injection of 20 microgram BRII-179 (VBI-2601) admixed with 3M International units of Interferon alpha(IFN-a) on Day 1, Week 4, Week 8 and Week 12
Cohort D participants will receive an IM injection of 40 microgram BRII-179 (VBI-2601) per dose on Day 1 Week 4, Week 8 and Week 12.
Cohort E participants will receive an IM injection of 40 microgram BRII-179 (VBI-2601) admixed with 3 MIU of IFN-a on Day 1, Week 4, Week 8 and Week 12.
Site of the intramuscular injection: Intramuscularly (IM) in deltoid muscle of right or left upper arm (alternated between each immunisation)
Participants will undergo either Part 1 or Part 2; participants of Cohort A (of Part 1) can participate in any Cohort of Part 2 after Week 16, if they wish to. All other cohort participants will only enrol to one Cohort of either Part 1 or Part 2.
Intervention code [1] 314914 0
Treatment: Drugs
Comparator / control treatment
Active control group; Cohort A will continue taking their nucleotide/nucleoside regimen as per normal.
Control group
Active

Outcomes
Primary outcome [1] 320623 0
Number of subjects with Adverse Events as assessed by CTCAE v5.0
Timepoint [1] 320623 0
Monitored throughout the study: during screening, Day 1, Day 2, Day 7, Day 28, Day 35, Day 56, Day 63, Day 84, Day 91, Day 112, Day 140 and Day 168.
Secondary outcome [1] 372247 0
Antiviral activity of BRII-179 (VBI-2601). Outcome is assessed by measurement of viral markers, e.g., HBsAg, anti-HBs, HBeAg, anti-HBe, with serum assays and it is a composite secondary outcome
Timepoint [1] 372247 0
Monitored at Weeks 4, 8, 12, 16, 20 and 24.
Timepoints of assessment of this outcome: Post enrolment and Post-treatment
Its treatment completion (EOS), then week followed by 4,8,12, 24 are post enrolment.
Secondary outcome [2] 372248 0
Pharmacodynamic effect of BRII-179 (VBI-2601). Outcome is assessed by measurement of biomarkers of immune responses with serum and blood cellular assays, and it is a composite secondary outcome
Timepoint [2] 372248 0
Monitored at Weeks 4, 8, 12, 16, 20 and 24.
Timepoints of assessment of this outcome: post-treatment

Eligibility
Key inclusion criteria
1) Male or female age 18 to 60
2) BMI 18 to 32 kg per meter 2
3) Chronic HBV infection for greater than or equal 6 months
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
2) Significant fibrosis or cirrhosis
3) History or evidence of drug or alcohol abuse
4) History of intolerance to intramuscular injection
5) History of chronic liver disease from any cause other than chronic HBV infection
6) History of hepatic decompensation

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
12/11/2019
Date of last participant enrolment
Anticipated
31/03/2020
Actual
1/07/2020
Date of last data collection
Anticipated
30/09/2020
Actual
15/12/2020
Sample size
Target
65
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 21664 0
Korea, Republic Of
State/province [1] 21664 0
Country [2] 21665 0
Thailand
State/province [2] 21665 0
Country [3] 21666 0
New Zealand
State/province [3] 21666 0
Country [4] 21667 0
China
State/province [4] 21667 0
Hong Kong, Beijing

Funding & Sponsors
Funding source category [1] 303189 0
Commercial sector/Industry
Name [1] 303189 0
Brii Biosciences
Address [1] 303189 0
Room 301, 3/F,
Building 7,
No. 1 Yongtaizhuang North Street,
Haidian District, Beijing
Country [1] 303189 0
China
Primary sponsor type
Commercial sector/Industry
Name
Brii Biosciences
Address
Room 301, 3/F,
Building 7,
No. 1 Yongtaizhuang North Street,
Haidian District, Beijing
Country
China
Secondary sponsor category [1] 303203 0
None
Name [1] 303203 0
Address [1] 303203 0
Country [1] 303203 0
Other collaborator category [1] 280832 0
Commercial sector/Industry
Name [1] 280832 0
Novotech (Australia) Pty Limited
Address [1] 280832 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 280832 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303753 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 303753 0
Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington, 6011
Ethics committee country [1] 303753 0
New Zealand
Date submitted for ethics approval [1] 303753 0
25/06/2019
Approval date [1] 303753 0
26/08/2019
Ethics approval number [1] 303753 0

Summary
Brief summary
This is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94674 0
Dr Tien Huey Lim
Address 94674 0
Middlemore Clinical Trials, Esme Green Building, 100 Hospital Road, Papatoetoe, Auckland, New Zealand, 1640
Country 94674 0
New Zealand
Phone 94674 0
+64 9 2760044
Fax 94674 0
Email 94674 0
TienHuey.Lim@middlemore.co.nz
Contact person for public queries
Name 94675 0
Dr Yao Zhang
Address 94675 0
Beijing Yintai Centre Tower C, Suite 3115
No. 2 Jianguomenwai Ave., Chaoyang District
Beijing, PRC
Country 94675 0
China
Phone 94675 0
+86 18600094236
Fax 94675 0
Email 94675 0
yao.zhang@briibio.com
Contact person for scientific queries
Name 94676 0
Dr Yao Zhang
Address 94676 0
Beijing Yintai Centre Tower C, Suite 3115
No. 2 Jianguomenwai Ave., Chaoyang District
Beijing, PRC
Country 94676 0
China
Phone 94676 0
+86 18600094236
Fax 94676 0
Email 94676 0
yao.zhang@briibio.com

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary