Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727267
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2022-11-06
Brief Title:
A Heterologous Protein PrimeMVA Boost Therapeutic Hepatitis B Vaccine Candidate
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
TherVacB_Phase1a Open Phase 1a Trial to Assess the Safety and Immunogenicity of a Heterologous Protein PrimeMVA Boost Therapeutic Hepatitis B Vaccine Candidate in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label ascending dose phase 1a trial to assess the safety and immunogenicity of a heterologous protein primeMVA boost therapeutic hepatitis B vaccine
Detailed Description:
The clinical trial is divided into two overlapping parts part I and part II in 24 healthy male and female subjects aged 18-65 years
Part I N 11 Protein prime vaccinations two times day 0 and 28 and MVA based boost vaccination 1 x day 56 3 subjects will be allocated to A0 and receive HEPLISAV B and a boost with MVA-HBVac high dose 3 subjects will be allocated to B01 and receive HEPLISAV B HBcoreAg low dose and a boost with MVA-HBVac low dose 5 subjects will be allocated to B02 and receive 2 x HEPLISAV B HBcoreAg medium dose and a boost with MVA-HBVac high dose Part II N 13 Protein prime vaccinations two times day 0 and 28 and MVA based boost with MVA-HBVac high dose on day 56 3 subjects will be allocated to C01 and receive HBsAg high dose HBcoreAg high dose plus boost 5 subjects will be allocated to C02 and receive HBsAg medium dose adjuvant low dose HBcoreAg medium dose plus boost 5 subjects will be allocated to C03 and receive HBsAg high dose adjuvant high dose HBcoreAg high dose plus boost
Part I N 11 Protein prime vaccinations two times day 0 and 28 and MVA based boost vaccination 1 x day 56 3 subjects will be allocated to A0 and receive HEPLISAV B and a boost with MVA-HBVac high dose 3 subjects will be allocated to B01 and receive HEPLISAV B HBcoreAg low dose and a boost with MVA-HBVac low dose 5 subjects will be allocated to B02 and receive 2 x HEPLISAV B HBcoreAg medium dose and a boost with MVA-HBVac high dose Part II N 13 Protein prime vaccinations two times day 0 and 28 and MVA based boost with MVA-HBVac high dose on day 56 3 subjects will be allocated to C01 and receive HBsAg high dose HBcoreAg high dose plus boost 5 subjects will be allocated to C02 and receive HBsAg medium dose adjuvant low dose HBcoreAg medium dose plus boost 5 subjects will be allocated to C03 and receive HBsAg high dose adjuvant high dose HBcoreAg high dose plus boost
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None