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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06070051




Registration number
NCT06070051
Ethics application status
Date submitted
20/09/2023
Date registered
6/10/2023
Date last updated
24/09/2024

Titles & IDs
Public title
Dose-Escalation Prime/Boost Therapeutic Vaccination Study of 2 Chimp Adenoviral Vectors in Adults with Chronic HBV on Nucleos(t)ide Therapy
Scientific title
A Phase 1b Multi-Center, Open-Label, Dose-Escalation, Prime and Boost Vaccination Evaluation of VRON-0200 Using Two Chimpanzee Adenoviral Vectors in Adult Participants with Chronic HBV Infection Who Are Currently Receiving HBV Nucleos(t)ide Reverse Transcriptase Inhibitors
Secondary ID [1] 0 0
21-0200-101
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 - VRON-0200-AdC6
Treatment: Other - VRON-0200-AdC7

Experimental: Cohort 1a: Low Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost - Participants assigned to Cohort 1a will receive a low dose prime vaccination of AdC7 vector on Day 1. They will receive a low dose boost vaccination of vector AdC6 on Day 91.

Experimental: Cohort 1b: Low Dose VRON-0200-AdC6 Prime, No Boost - Participants assigned to Cohort 1b will receive a low dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.

Experimental: Cohort 2a: High Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost - Participants assigned to Cohort 2a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive a high dose boost vaccination of AdC6 vector on Day 91.

Experimental: Cohort 2b: High Dose VRON-0200-AdC6 Prime, No Boost - Participants assigned to Cohort 2b will receive a high dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination.


Treatment: Other: VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector

Treatment: Other: VRON-0200-AdC7
VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Emergent Adverse Events
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Grade 3 Adverse Events
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Clinically Significant Changes in Lab Values
Timepoint [3] 0 0
28 days
Primary outcome [4] 0 0
Serious Adverse Events
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Medically Attended Adverse Events
Timepoint [5] 0 0
6 months
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
360 days
Secondary outcome [2] 0 0
T Cell Frequencies
Timepoint [2] 0 0
360 days

Eligibility
Key inclusion criteria
1. Documented chronic HBV infection (eg, HBsAg+ = 6 months with detectable HBsAg at screening)
2. Receipt of either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine for at least 12 months before screening with no reported antiviral resistance during this time; still on treatment at screening and expected to stay on therapy during the study period
3. Virally suppressed for > 12 months (HBV DNA < 40 IU/mL)
4. No clinical diagnosis of advanced liver fibrosis and/or cirrhosis
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of hepatic decompensation, advanced fibrosis, or liver transplantation
2. History of hepatocellular carcinoma
3. History of risk factors for thrombosis and thrombocytopenia
4. Documented hepatitis A, hepatitis C, hepatitis D, hepatitis E, or HIV (or history of prior active disease)
5. Pregnant, nursing, or planning a pregnancy during the trial

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Virion Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 1b clinical study is a multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study of 2 distinct chimpanzee adenoviral vectors (AdC6 and AdC7), containing parts of hepatitis B virus (HBV) core and polymerase antigens fused within glycoprotein D in a cohort of chronic hepatitis B (CHB)-infected adult participants who are currently receiving entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine, with documented HBV viral load suppression for at least 12 months.

Approximately 24 participants will be enrolled in Group 1 and randomized to Cohort 1a or Cohort 1b. Those assigned to Cohort 1a will receive a low dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 1b will receive a low dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination.

Group 2 will then enroll approximately 24 participants randomized to Cohort 2a or Cohort 2b. Those assigned to Cohort 2a will receive a high dose prime therapeutic vaccination of vector AdC7 on Day 1, followed by a booster vaccination on Day 91 using vector AdC6. Those assigned to Cohort 2b will receive a high dose prime therapeutic vaccination of vector AdC6 on Day 1, and will not receive a booster vaccination.

Group 3 will enroll approximately 8 participants randomized into Cohort 3a or Cohort 3b. Cohort 3a will receive the high dose prime VRON-0200 vaccination of vector AdC7 on Day 1, followed by doses of VIR-2218 plus VIR-3434 on Days 28, 56, 84, 112, 140 and 168, and then a booster using a high dose VRON-0200 vaccination of vector AdC6 on Day 196. Cohort 3b will receive the same high dose prime VRON-0200 vaccination of vector AdC7 followed by 6 doses of VIR-2218 plus VIR-3434 at the same timepoints as Cohort 3a, but will not receive the booster dose on Day 196.

VRON-0200 vaccine doses will be administered by intramuscular (IM) injection. VIR-2218 and VIR-3434 will be administered subcutaneously.

All study participants will be followed for a total of 1 year post-prime vaccination.
Trial website
https://clinicaltrials.gov/study/NCT06070051
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sue Currie, PhD
Address 0 0
Virion Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tony Baca, MBA
Address 0 0
Country 0 0
Phone 0 0
1-800-841-9303
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06070051