Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513286
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
TherVacB - A Heterologous Protein PrimeMVA Boost Therapeutic Hepatitis B Vaccine Candidate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TherVacB - A Multi-center Phase 1b2a Trial to Assess Safety Tolerability and Immunogenicity of a Heterologous Protein PrimeMVA Boost Therapeutic Hepatitis B Vaccine Candidate
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TherVacB
Brief Summary:
This study is an open-label ascending dose phase 1b2a trial to assess the safety and immunogenicity of a heterologous protein primeMVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies
Detailed Description:
This is a multi-centre study conducted in 89 participants The clinical trial is divided into two overlapping parts part A and B All treatment groups of Part A will receive HEPLISAV B on Day 1 and Day 29 and MVA-HBVac on Day 57 Study arms A1 until A3 will receive a single dose of HEPLISAV B on each day study arms A4 A5 and A6 either a single dose or a double dose of HEPLISAV B From study arm A2 on all participants also receive HBcoreAg in a low dose in arms A2 and A3 and in a medium dose in arm A4 In arms A5 and A6 either the low or the medium dose will be applied to an extended number of participants The MVA-HBVac booster dose will be given in a dose-escalating way with a low dose in arms A1 and A2 and a high dose in arms A3 A4 A5 and A6
All treatment groups of Part B will receive two times HBsAg HBcoreAg on day 1 and 29 and a high booster dose of MVA-HBVac on day 57 In study arm B1 a high dose of HBsAg and HBcoreAg will be applied In arm B2 a medium dose of HBsAg plus the adjuvant c-di-AMP in a low dose will be applied together with a medium dose of HBcoreAg In arm B3 a high dose of HBsAg plus a medium dose of the adjuvant will be applied together with a high dose of HBcoreAg In arm B4 either the regimen of B2 or B3 will be applied to an extended number of participants
All treatment groups of Part B will receive two times HBsAg HBcoreAg on day 1 and 29 and a high booster dose of MVA-HBVac on day 57 In study arm B1 a high dose of HBsAg and HBcoreAg will be applied In arm B2 a medium dose of HBsAg plus the adjuvant c-di-AMP in a low dose will be applied together with a medium dose of HBcoreAg In arm B3 a high dose of HBsAg plus a medium dose of the adjuvant will be applied together with a high dose of HBcoreAg In arm B4 either the regimen of B2 or B3 will be applied to an extended number of participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None