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

NCT06430905 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: H-500-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Keywords

human immunodeficiency virus; HIV; vaccine; immunotherapy; arenavirus; genetic vector; antiretroviral therapy; ART

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs)

  Assess the safety of HB-502 and HB-501 alternating 2-vector therapy compared with placebo by monitoring the type, frequency, and severity of unsolicited treatment-emergent and serious AEs, using the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017.

  From first dosing until 48 weeks after first dosing

• Number of participants with local injection site reactions

  Assess the frequency and type of solicited local injection site reactions in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017.

  From first dosing until 48 weeks after first dosing

• Number of participants with systemic reactogenicity events

  Assess the frequency and type of solicited systemic reactogenicity events in response to HB-502 and HB-501 alternating 2-vector therapy compared with placebo, using the DAIDS Table for Grading the Severity of Adult and Pediatric AEs, Corrected Version 2.1, July 2017.

  From first dosing until 48 weeks after first dosing

Secondary Outcomes (2)

• Determine the magnitude of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo

  From first dosing until 48 weeks after first dosing

• Determine the breadth of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo

  From first dosing until 48 weeks after first dosing

Study Arms (2)

HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo

EXPERIMENTAL

Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 1 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24).

Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 1; Other: Placebo

HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo

EXPERIMENTAL

Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 2 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24).

Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 2; Other: Placebo

Interventions

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

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

HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo

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

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

HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo

Placebo OTHER

Administration of placebo to 5 participants.

HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo; HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 18 to 65 years of age.
• Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening.
• Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening.
• Must have plasma HIV RNA levels of \<50 copies/mL (or lower limit of quantitation) for at least 48 weeks prior to enrollment.
• Must have a cluster of differentiation (CD)4+ cell count \>450 cells/mm3 and CD4+ cell % of ≥15% obtained within 40 days prior to enrollment.
• Is in good general health according to the clinical judgment of the site Investigator.

You may not qualify if:

• History of hypersensitivity or other contraindication to any of the components of the study interventions as determined by the Investigator.
• HIV-associated malignancy according to the National Cancer Institute (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers.
• History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy.
• More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014).
• Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 156 weeks (i.e., 3 years) prior to enrollment.
• Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus RNA is detected \[qualitative\]).
• Current untreated or incompletely treated active TB disease or untreated latent TB infection.
• Has any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results.
• Is a previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
• Received non-HIV experimental vaccine(s) within the last 1 year.
• Has congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site Investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the Investigator within 24 weeks prior to the start of study therapy.
• Received blood products or immunoglobulin within 16 weeks prior to enrollment.
• Received systemic steroids at a dose of ≥10 mg/day (prednisone equivalent) for \<30 within 14 days or for ≥30 days within 28 days of first dose of study treatment.
• Received any vaccine within 4 weeks prior to enrollment.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or contraindicate participation in this study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.

Sponsors & Collaborators

• Hookipa Biotech GmbH: lead

Study Sites (5)

Orlando Immunology Center (OIC)

Orlando, Florida, 32803, United States

Location

The Hope Clinic at Emory University

Decatur, Georgia, 30030, United States

Location

Brigham and Women´s Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconness Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Head of Clinical Development

  Hookipa Biotech GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: July 1, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (5)