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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05343481
Registration number
NCT05343481
Ethics application status
Date submitted
12/04/2022
Date registered
25/04/2022
Date last updated
16/09/2025
Titles & IDs
Public title
Efficacy of VTP-300 in Chronic Hepatitis B Infection
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Scientific title
A Phase 2b, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity and Treatment Regimens of VTP-300 Combined With Low-dose Nivolumab in Chronic Hepatitis B Infection
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Secondary ID [1]
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HBV-003
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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 - ChAdOx1-HBV
Treatment: Other - MVA-HBV
Treatment: Other - Nivolumab
Experimental: Experimental: Group 1 ChAdOx1-HBV, MVA-HBV and nivolumab - Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
Experimental: Experimental: Group 2 ChAdOx1-HBV, MVA-HBV and nivolumab, MVA-HBV and nivolumab - Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion Day 85: MVA-HBV 1 x 10\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion
Experimental: Experimental: Group 3 ChAdOx1-HBV, MVA-HBV, nivolumab, MVA-HBV - Day 1: ChAdOx1-HBV 1 x 2.5 10\^10 vp IM injection Day 29: MVA-HBV 1 x 10\^8 pfu IM injection Day 36: Nivolumab 0.3 mg/kg IV infusion Day 85: MVA-HBV 1 x 10\^8 pfu IM injection
Treatment: Other: ChAdOx1-HBV
Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus immunotherapeutic
Treatment: Other: MVA-HBV
Modified Vaccinia Ankara-vectored Hepatitis B virus immunotherapeutic
Treatment: Other: Nivolumab
Human immunoglobulin G4 monoclonal antibody
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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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The incidence of participants with a greater than 1 log HBsAg
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Assessment method [1]
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Percentage of participants with a greater than 1 log HBsAg reduction at 6 months after initiation of therapy
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Timepoint [1]
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6 months after the initiation of therapy
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Secondary outcome [1]
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The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and =Grade 3 related adverse events following study treatment
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Assessment method [1]
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The incidence of TEAEs and and =Grade 3 related adverse events will be based on the number and percentage of participants with events and number of events. TEAEs are defined as all adverse events occurring after study IMP administration; they will be further categorised by Seriousness, Severity (i.e. = Grade 3) and Causality.
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Timepoint [1]
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From each study vaccination for the following 7 days
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Secondary outcome [2]
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The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) and =Grade 3 related adverse events following administration with nivolumab
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Assessment method [2]
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The incidence of TEAEs and =Grade 3 related adverse events will be based on the number and percentage of participants with events and number of events. TEAEs are defined as all adverse events occurring after study IMP administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. = Grade 3) according to FDA Guidance 70 FR 22664 and Causality.
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Timepoint [2]
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From each study administration with nivolumab for the following 7days
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Secondary outcome [3]
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The incidence of participants with Adverse Events of Special Interest (AESIs)
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Assessment method [3]
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AESIs specific to this study include pneumonitis, grade 3 or 4 diarrhoea, diabetes, thyroid diseases, colitis, nephritis, immune-related endocrinopathies, myocarditis, immune-related skin conditions, or other unspecified immune-related adverse reactions
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Timepoint [3]
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From study admission (the signature of informed consent) to the end of the study (Month 12)
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Secondary outcome [4]
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The incidence of participants with Treatment-Emergent Adverse Events (TEAEs) within each study group
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Assessment method [4]
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The incidence of TEAEs will be based on the number and proportion of participants with events and number of events and will be calculated for each of the three study groups
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Timepoint [4]
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From each study administration for the following 7 days
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Secondary outcome [5]
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Incidence of participants with potentially clinically significant laboratory signs within each treatment group as assessed by the Investigator
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Assessment method [5]
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The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant laboratory signs (haematology and biochemistry, including liver function tests) as assessed by the investigator. All laboratory signs will be reported in SI units. If any laboratory sign is considered to be clinically significant i.e. outside laboratory normal reference range, the severity of this sign will be assessed according to the FDA Guidance for Industry 70 FR 22664. Absolute change, change from baseline and worst change for each participant will be calculated. The incidence of participants with treatment-emergent, clinically significant laboratory signs and laboratory signs of Grade 3-4 severity will be calculated for each treatment group at each time point
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Timepoint [5]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [6]
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Incidence of participants with potentially clinically significant vital signs within each treatment group as assessed by the Investigator
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Assessment method [6]
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The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant vital signs. Vital signs will be considered to be potentially clinically significant if they respectively fall below or above the relevant upper and lower limits. The incidence of participants with treatment-emergent, clinically significant vital signs will be calculated for each treatment group at each time point.
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Timepoint [6]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [7]
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Number of participants with worst changes from baseline in laboratory hematology parameters
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Assessment method [7]
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Hematology laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA). For all hematology parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study. The number of participants showing shifts of at least two severity grades (as worst change from baseline for each hematology parameter) will be presented within shift tables.
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Timepoint [7]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [8]
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Number of participants with worst changes from baseline in laboratory biochemistry parameters
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Assessment method [8]
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Biochemistry laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA). For all biochemistry parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study. The number of participants showing shifts of at least two severity grades (as worst change from baseline for each biochemistry parameter) will be presented within shift tables.
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Timepoint [8]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [9]
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Number of participants with worst changes from baseline in laboratory urinalysis parameters
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Assessment method [9]
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Urinalysis laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA). For all urinalysis parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study. The number of participants showing shifts of at least two severity grades (as worst change from baseline for each urinalysis parameter) will be presented within shift tables.
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Timepoint [9]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [10]
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Number of participants with worst changes from baseline in vital signs parameters (heart rate, systolic blood pressure, diastolic blood pressure and temperature)
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Assessment method [10]
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Worst change is defined as the lowest and highest post-baseline values for heart rate (bradycardia, tachycardia) and systolic blood pressure (hypotension, hypertension), and as the highest post-baseline values for diastolic blood pressure (hypertension) and temperature (fever). For all vital signs' measurements, changes from baseline will be calculated for each timepoint at which the vital sign measurement is conducted throughout the study. The number of participants showing worst change from baseline for the vital signs parameters overall will be presented within shift tables.
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Timepoint [10]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Secondary outcome [11]
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T cell response to the HBV antigen inserts of VTP-300 as measured by interferon (IFN)-? enzyme-linked immunospot (ELISpot)
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Assessment method [11]
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This will be determined by using PMBCs in IFN-? ELISpot assays to investigate the breadth of HBV specific T cell responses (defined by number of peptide pools or individual peptides recognised). These data may be used to build immunologic models of the immune system.
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Timepoint [11]
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Baseline, Day 8, Day 29, Day 36, Day 57, Day 85, Day 92, Day 113, Day 169, Day 252 and Day 336
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Eligibility
Key inclusion criteria
1. Adult males or females aged =18 to =65 years at screening (according to country/local regulations)
2. BMI =35 kg/m2
3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
4. If female, willing not to become pregnant up to 8 weeks after the last dose of study vaccine and up to 5 months after the last dose of nivolumab
5. If female: Not pregnant or breast feeding and one of the following:
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in =1 year and without an alternative medical cause)
* Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after VTP-300 and 5 months after the last dose of nivolumab. Highly effective methods of contraception include one or more of the following:
* Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant
* Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal
* Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
* An intrauterine device
* Bilateral tubal occlusion
* Abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
6. Documented evidence of CHB infection (e.g., HBsAg positive =6 months with detectable HBsAg levels at screening; both HBeAg+ and HBeAg- allowed)
7. Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate) or besifovir for at least 6 months before screening
8. HBV-DNA viral load = 1,000 IU/mL
9. HBsAg levels > 10 and = 4,000 IU/mL
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Minimum age
18
Years
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Maximum age
65
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. Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the study requirements
2. Medical history that is thought to increase the participant's risk of reaction to a vaccine, including but not limited to capillary leak syndrome; transverse myelitis, Guillain Barré syndrome, thrombosis with thrombocytopenia syndrome (also termed vaccine-induced thrombotic thrombocytopenia); heparin-induced thrombocytopenia HCV RNA positive
3. HIV antibody positive and active hepatitis C (antibody positive and then DNA positive)
4. Co-infection with hepatitis D virus (HDV)
5. Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to Day 0 (Metavir activity grade A4 and stage F4; Ishak stages 5 - 6).
6. In the absence of a documented liver biopsy, either 1 of the following (not both):
* Screening Fibroscan with a result >9 kilopascals (kPa) (or the equivalent) within = 6 months of screening, OR
* Both screening FibroTest >0.48 and aspartate aminotransferase (AST) to platelet ratio index (APRI) of >1.
7. ALT >3 x ULN, or INR >1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin <3.2 g/dL, direct bilirubin >1.5 x ULN, platelet count <100,000/µL.
8. A history of liver decompensation (e.g., ascites, encephalopathy or variceal haemorrhage)
9. Prior hepatocellular carcinoma
10. Chronic liver disease of a non-HBV aetiology. (Note that Gilbert's syndrome, asymptomatic gallstones and non-alcoholic fatty liver not associated with steatohepatitis are not exclusions)
11. History or evidence of autoimmune disease or known immunodeficiency of any cause except history of autoimmune thyroiditis if the participant is stable on replacement therapy
12. Evidence of interstitial lung disease, active pneumonitis, myocarditis or a history of myocarditis
13. Prolonged therapy with immunomodulators (e.g., corticosteroids such as prednisone >10 mg/day) or biologics (e.g., monoclonal antibodies, IFN) within 3 months of Day 1. Inhaled, intra-articular, intra-bursal or topical corticosteroids are allowed. Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed.
14. Receipt of immunoglobulin or other blood products within 3 months prior to Day 1
15. Receipt of any investigational drug or vaccine within 3 months prior to Day 1
16. Receipt of any non-oral adenoviral-based vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 1
17. Severe reaction to any vaccine, requiring medical attention
18. Receipt of any live vaccines within 30 days prior to Day 1
19. Receipt of any inactivated non-live vaccines (e.g., mRNA, inactivated vaccines, toxoid vaccines) within 14 days prior to Day 1
20. History of severe hypersensitivity or anaphylactic reactions likely to be exacerbated by any component of VTP-300 or nivolumab, including severe allergy to egg
21. Malignancy within 5 years prior to screening with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Participants under evaluation for possible malignancy are not eligible
22. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant safety or compliance
23. Any laboratory test which is abnormal, and which is deemed by the investigator to be clinically significant
24. Any other finding that, in the opinion of the investigator, deems the participant unsuitable for the study
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
21/09/2022
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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
1/10/2026
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Actual
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Sample size
Target
120
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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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Taiwan
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State/province [2]
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Chiayi City
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Country [3]
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Taiwan
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State/province [3]
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Kaohsiung City
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Country [4]
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Taiwan
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State/province [4]
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Taichung
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Country [5]
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Taiwan
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State/province [5]
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Tainan City
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Country [6]
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Taiwan
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State/province [6]
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Taipei
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Country [7]
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Taiwan
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State/province [7]
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Taoyuan
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Country [8]
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Thailand
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State/province [8]
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Bangkok
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Country [9]
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Thailand
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State/province [9]
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Chiang Mai
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Country [10]
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Thailand
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State/province [10]
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Khon Kaen
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Country [11]
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Thailand
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State/province [11]
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Nonthaburi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Barinthus Biotherapeutics
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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 is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.
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Trial website
https://clinicaltrials.gov/study/NCT05343481
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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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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Address
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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 scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT05343481
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