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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
10/10/2023
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
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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
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Secondary ID [1]
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21-0200-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment Emergent Adverse Events
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Assessment method [1]
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Number and percent of participants with 1 or more treatment-emergent adverse events within 28 days after each therapeutic vaccine dose by cohort.
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Timepoint [1]
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28 days
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Primary outcome [2]
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Grade 3 Adverse Events
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Assessment method [2]
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Number and percent of participants with Grade 3 or higher local and/or systemic reactions within 28 days after each therapeutic vaccine dose by cohort.
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Timepoint [2]
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28 days
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Primary outcome [3]
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Clinically Significant Changes in Lab Values
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Assessment method [3]
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Number and percent of participants with clinically significant changes from pre-vaccination laboratory values within 28 days after each therapeutic vaccine dose by cohort.
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Timepoint [3]
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28 days
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Primary outcome [4]
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Serious Adverse Events
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Assessment method [4]
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Number and percent of participants with serious adverse events within 6 months after each therapeutic vaccine dose by cohort.
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Timepoint [4]
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6 months
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Primary outcome [5]
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Medically Attended Adverse Events
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Assessment method [5]
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Number and percent of participants with medically attended adverse events within 6 months after each therapeutic vaccine dose by cohort.
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Timepoint [5]
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6 months
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Secondary outcome [1]
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Adverse Events
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Assessment method [1]
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Number and percentage of adverse events for all participants through Day 360.
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Timepoint [1]
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360 days
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Secondary outcome [2]
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T Cell Frequencies
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Assessment method [2]
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Change from baseline in vaccine-induced CD8+ T cell frequencies in the blood.
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Timepoint [2]
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360 days
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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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/01/2025
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Virion Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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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. All vaccine doses will be administered by intramuscular (IM) injection. All study participants will be followed for a total of 1 year post-prime vaccination.
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Trial website
https://clinicaltrials.gov/study/NCT06070051
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sue Currie, PhD
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Address
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Virion Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tony Baca, MBA
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Address
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Country
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Phone
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1-800-841-9303
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT06070051
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