Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy - Trial NCT06070051

Timeline & Enrollment

Primary Outcome

Treatment Emergent Adverse Events,Grade 3 Adverse Events,Clinically Significant Changes in Lab Values,Serious Adverse Events,Medically Attended Adverse Events

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.

ICD-10 Classifications