Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy

October 6, 2023 updated by: Virion Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Auckland City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector
Biological: VRON-0200-AdC7
VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector
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.
Biological: VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector
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.
Biological: VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector
Biological: VRON-0200-AdC7
VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector
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.
Biological: VRON-0200-AdC6
VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events
Time Frame: 28 days
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
Grade 3 Adverse Events
Time Frame: 28 days
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
Clinically Significant Changes in Lab Values
Time Frame: 28 days
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
Serious Adverse Events
Time Frame: 6 months
Number and percent of participants with serious adverse events within 6 months after each therapeutic vaccine dose by cohort.
6 months
Medically Attended Adverse Events
Time Frame: 6 months
Number and percent of participants with medically attended adverse events within 6 months after each therapeutic vaccine dose by cohort.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 360 days
Number and percentage of adverse events for all participants through Day 360.
360 days
T Cell Frequencies
Time Frame: 360 days
Change from baseline in vaccine-induced CD8+ T cell frequencies in the blood.
360 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis B Virus DNA
Time Frame: 360 days
Quantitative changes from baseline over time in HBV DNA
360 days
Hepatitis B Virus Pregenomic RNA
Time Frame: 360 days
Quantitative changes from baseline over time in HBV pgRNA
360 days
Hepatitis B Surface Antigen
Time Frame: 360 days
Quantitative changes from baseline over time in HBsAg
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virion Therapeutics

Investigators

  • Study Director: Sue Currie, PhD, Virion Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

July 23, 2024

Study Completion (Estimated)

January 23, 2025

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-0200-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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