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Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART

NCT06430905 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus (HIV) Infection

Interventions

BIOLOGICAL

HB-502 and HB-501 alternating 2-vector therapy Dose Level 2

Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants.

OTHER

Placebo

Administration of placebo to 5 participants.

BIOLOGICAL

HB-502 and HB-501 alternating 2-vector therapy Dose Level 1

Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants.

Sponsors & Collaborators

  • Hookipa Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Head of Clinical Development · Hookipa Biotech GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-07-18
Completion
2025-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430905 on ClinicalTrials.gov