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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06070051
Other study ID # 21-0200-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 26, 2023
Est. completion date January 23, 2025

Study information

Verified date October 2023
Source Virion Therapeutics
Contact Tony Baca, MBA
Phone 1-800-841-9303
Email tbaca@viriontx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date January 23, 2025
Est. primary completion date July 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 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


Intervention

Biological:
VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector
VRON-0200-AdC7
VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector

Locations

Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong
New Zealand Auckland City Hospital Auckland

Sponsors (1)

Lead Sponsor Collaborator
Virion Therapeutics

Countries where clinical trial is conducted

Hong Kong,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Other Hepatitis B Virus DNA Quantitative changes from baseline over time in HBV DNA 360 days
Other Hepatitis B Virus Pregenomic RNA Quantitative changes from baseline over time in HBV pgRNA 360 days
Other Hepatitis B Surface Antigen Quantitative changes from baseline over time in HBsAg 360 days
Primary Treatment Emergent Adverse Events Number and percent of participants with 1 or more treatment-emergent adverse events within 28 days after each therapeutic vaccine dose by cohort. 28 days
Primary Grade 3 Adverse Events 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. 28 days
Primary Clinically Significant Changes in Lab Values Number and percent of participants with clinically significant changes from pre-vaccination laboratory values within 28 days after each therapeutic vaccine dose by cohort. 28 days
Primary Serious Adverse Events Number and percent of participants with serious adverse events within 6 months after each therapeutic vaccine dose by cohort. 6 months
Primary Medically Attended Adverse Events Number and percent of participants with medically attended adverse events within 6 months after each therapeutic vaccine dose by cohort. 6 months
Secondary Adverse Events Number and percentage of adverse events for all participants through Day 360. 360 days
Secondary T Cell Frequencies Change from baseline in vaccine-induced CD8+ T cell frequencies in the blood. 360 days
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