Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430905
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-17
Brief Title:
Safety Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART
Sponsor:
Hookipa Biotech GmbH
Organization:
Hookipa Biotech GmbH
Study Overview
Official Title:
A Phase 1b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Reactogenicity and Immunogenicity of Arenavirus-based Vector Therapy HB-502 and HB-501 in People With HIV on Suppressive Antiretroviral Treatment
Status:
RECRUITING
Status Verified Date:
2024-10
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 is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus HIV who are taking antiretroviral treatment ART
The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV
This trial studies the safety tolerability and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV
Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment
The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV
This trial studies the safety tolerability and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV
Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment
Detailed Description:
This is a first-in-human Phase 1b randomized double-blind placebo-controlled multicenter study of HB-502 and HB-501 alternating 2-vector therapy in participants with HIV who are in overall good health and on suppressive ART The study will evaluate the safety reactogenicity and immunogenicity of HB-502 and HB-501 alternating 2-vector therapy
HB-502 and HB-501 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus respectively The HB-502 and HB-501 vectors have been engineered to deliver HIV antigens derived from parts of key immunogenic regions of HIV type 1 HIV-1 proteins that are highly conserved within HIV-1 clade B variants The designed immunogens differ from each other by their amino acid sequence allowing for coverage of 80 of circulating HIV-1 viral variants
Two different dose levels Dose Level 1 and Dose Level 2 of HB-502 and HB-501 alternating 2-vector therapy or placebo will be administered intramuscularly every 8 weeks for 24 weeks ie 4 doses at Weeks 0 8 16 and 24 which is followed by a 24-week follow-up period
In total approximately 30 participants aged 18 to 65 years will be enrolled in this study to receive HB-502 and HB-501 alternating 2-vector therapy or placebo
About 5 Investigators and study sites in the United States are expected to participate in this study
HB-502 and HB-501 are genetically engineered replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus respectively The HB-502 and HB-501 vectors have been engineered to deliver HIV antigens derived from parts of key immunogenic regions of HIV type 1 HIV-1 proteins that are highly conserved within HIV-1 clade B variants The designed immunogens differ from each other by their amino acid sequence allowing for coverage of 80 of circulating HIV-1 viral variants
Two different dose levels Dose Level 1 and Dose Level 2 of HB-502 and HB-501 alternating 2-vector therapy or placebo will be administered intramuscularly every 8 weeks for 24 weeks ie 4 doses at Weeks 0 8 16 and 24 which is followed by a 24-week follow-up period
In total approximately 30 participants aged 18 to 65 years will be enrolled in this study to receive HB-502 and HB-501 alternating 2-vector therapy or placebo
About 5 Investigators and study sites in the United States are expected to participate in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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