Human Immunodeficiency Virus (HIV) InfectionPhase 1NCT06430905
Safety, Reactogenicity and Immunogenicity of HB-502 and HB-501 Versus Placebo in People With HIV on Suppressive ART
A Phase 1 study testing HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 and HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 in people with Human Immunodeficiency Virus (HIV) Infection, run by Hookipa Biotech GmbH at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection
- What is being tested?
- HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 and HB-502 and HB-501 alternating 2-vector therapy Dose Level 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jul 2024to 18 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
Show all 17Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Brigham and Women´s Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconness Medical Center (BIDMC)
Boston, Massachusetts, 02215
The Hope Clinic at Emory University
Decatur, Georgia, 30030
Orlando Immunology Center (OIC)
Orlando, Florida, 32803
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- HB-502 and HB-501 alternating 2-vector therapy Dose Level 1, HB-502 and HB-501 alternating 2-vector therapy Dose Level 2, Placebo
- Keywords
- human immunodeficiency virus, HIV, vaccine, immunotherapy, arenavirus, genetic vector, antiretroviral therapy, ART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-502 and HB-501 alternating 2-vector therapy Dose Level 1Biological
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 2Biological
Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants.
PlaceboOther
Administration of placebo to 5 participants.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 2; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Assess changes from baseline in the magnitude of T cell response specific to the transgenes harbored in HB-502 and HB-501.
Measured: 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
Assess changes from baseline in the breadth of T cell responses to the different transgenes harbored in HB-502 and HB-501.
Measured: From first dosing until 48 weeks after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jul 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Why it stopped: business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hookipa Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Clinical Development, Study director, Hookipa Biotech GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430905
- Sponsor's protocol ID
- H-500-001
- Status last verified
- Nov 2025
- First submitted
- 17 May 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06430905
- Acronym / sponsor ID
- H-500-001
- Keywords
- human immunodeficiency virus, HIV, vaccine, immunotherapy, arenavirus, genetic vector, antiretroviral therapy, ART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hookipa Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placebo | Experimental | Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 1, Other: PlaceboIntramuscular 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). |
| HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo | Experimental | Biological: HB-502 and HB-501 alternating 2-vector therapy Dose Level 2, Other: PlaceboIntramuscular 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-502 and HB-501 alternating 2-vector therapy Dose Level 1Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. | Biological | 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 2Administration of HB-502 and HB-501 alternating 2-vector therapy to 10 participants. | Biological | HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placebo |
| PlaceboAdministration of placebo to 5 participants. | Other | 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 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From first dosing until 48 weeks after first dosing
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.
Number of participants with local injection site reactions
Time frame: From first dosing until 48 weeks after first dosing
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.
Number of participants with systemic reactogenicity events
Time frame: From first dosing until 48 weeks after first dosing
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.
2 secondary outcomes
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
Time frame: 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
Time frame: From first dosing until 48 weeks after first dosing
Results and safety
The study was stopped early (reason given: business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Related trials for Human Immunodeficiency Virus (HIV) Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Clinical Development study director
Hookipa Biotech GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB-502 and HB-501 alternating 2-vector therapy Dose Level 1 and HB-502 and HB-501 alternating 2-vector therapy Dose Level 2 in people with Human Immunodeficiency Virus (HIV) Infection, run by Hookipa Biotech GmbH at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: From first dosing until 48 weeks after first dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.