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

Launched by HOOKIPA BIOTECH GMBH · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two experimental treatments, called HB-502 and HB-501, in people living with HIV who are already taking medication to keep their virus levels low. The goal of the trial is to see if these treatments can help the immune system recognize and fight HIV more effectively. Participants will receive injections of the study treatments every eight weeks for a total of 24 weeks. After the last injection, researchers will continue to monitor the participants for another 24 weeks to ensure the treatments are safe and to see how well the immune system is responding to them.

To be eligible for the trial, participants need to be between 18 and 65 years old, have confirmed HIV infection, and have been on stable HIV treatment for at least 48 weeks with very low levels of the virus in their blood. They should also be in generally good health. However, individuals with certain health issues or those who have received specific recent treatments may not qualify. Participants in the trial can expect regular check-ups and support throughout the study period, and they will play an important role in helping researchers learn more about potential new ways to fight HIV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Initiated antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary).
• • 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.
• • Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 12 weeks after the last dose of trial treatment.

Trial Officials