Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 12:55 PM
Study NCT ID:
NCT06430905
Status:
TERMINATED
Last Update Posted:
2025-11-18
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
business decision
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 (i.e., 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 (i.e., 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:
True
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?: