HIV-1Phase 1NCT06680479
Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
A Phase 1 study testing CH505 TF chTrimer, 3M-052-AF and Aluminum Hydroxide Suspension in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.
Trial summary
A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- CH505 TF chTrimer, 3M-052-AF and Aluminum Hydroxide Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Apr 2025to 14 Apr 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection
- On a suppressive ART regimen for at least 24 months with no changes in the 90 days prior to study entry
- CD4+ cell count greater than 200 cells/mm3 obtained within 56 days prior to study entry
- HIV-1 RNA <200 copies/mL obtained within 56 days prior to study entry
- Plasma HIV-1 RNA levels <200 copies/mL for at least 12 months on ART prior to study entry
- The following laboratory values obtained within 56 days prior to study entry
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- White blood cell count ≥2,500 cells/mm3
- Absolute neutrophil count (ANC) >750/mm3
- Hemoglobin ≥11 g/dL for cisgender men/transgender women and ≥10 g/dL for cisgender women/transgender men
- Platelet count ≥100,000/mm3
- Creatinine <1.5x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) (SGPT) ≤1.5 ULN
- Hepatitis C Virus (HCV) antibody-negative or HCV RNA negative result if indicated, within 56 days prior to study entry
- Negative hepatitis B surface antigen (HBsAg) result obtained within 56 days prior to study entry
- For study candidates of child-bearing potential, negative serum or urine pregnancy test at screening and within 48 hours prior to study entry
- No participation in conception process and agree to use at least one reliable form of contraception if participating in sexual activity that could lead to pregnancy during the study and for 8 weeks following the final study vaccine
Who cannot join
- Known to have started ART during acute HIV infection
- Known to have HIV-related opportunistic infections within the last 2 years prior to study entry.
- History of malignancy within the last 5 years prior to study entry.
- Currently breastfeeding
- History of or active autoimmune disorders
- HIV vaccination (prophylactic and/or therapeutic) within 1 year prior to study entry
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- Receipt of any anti-HIV-1 bNAbs within 2 years prior to study entry
- Vaccination within 4 weeks prior to study entry
- Use of any infusion blood product or immune globulin within 16 weeks prior to study entry (Exception: COVID-19-specific monoclonal antibodies are allowed)
- Use of systemic immunomodulators, systemic cytotoxic chemotherapy, or non-FDA approved investigational therapy within 60 days prior to study entry
- Intent to use immunomodulators during the course of the study
- Immune deficiency other than HIV
- HCV antiviral therapy within 90 days prior to screening
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Conditions that would preclude injection site reaction assessments (e.g., extensive tattoos, scarring, skin conditions).
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012
University of Colorado Hospital CRS
Aurora, Colorado, 80045
Johns Hopkins University CRS
Baltimore, Maryland, 21287
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, 02114
Chapel Hill CRS
Chapel Hill, North Carolina, 27599-7215
Northwestern University CRS
Chicago, Illinois, 60611
Cincinnati CRS
Cincinnati, Ohio, 45267-0405
Case CRS
Cleveland, Ohio, 44106
Ohio State University CRS
Columbus, Ohio, 43210
Houston Advancing Research Team CRS
Houston, Texas, 77030
University of California, Los Angeles CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204
Weill Cornell Chelsea CRS
New York, New York, 10010
Columbia Physicians & Surgeons (P&S) CRS
New York, New York, 10032
Weill Cornell Uptown CRS
New York, New York, 10065
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, 07103
Penn Therapeutics CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, 14642
UCSD Antiviral Research Center CRS
San Diego, California, 92103
University of California, San Francisco HIV/AIDS CRS
San Francisco, California, 94110
University of Washington Positive Research CRS
Seattle, Washington, 98104
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010
Harbor University of California Los Angeles Center CRS
Torrance, California, 90502-2052
About this study
A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in adults living with HIV-1 on suppressive antiretroviral therapy (ART) with the aim of inducing new HIV-1 Envelope (Env) B-cell neutralizing immune responses. Participants will be on study for up to 100 weeks (52 weeks on study treatment plus 48 weeks follow-up).
- Conditions
- HIV-1
- Being tested
- CH505 TF chTrimer, 3M-052-AF, Aluminum Hydroxide Suspension, Sodium Chloride for Injection
- Keywords
- HIV, Therapeutic vaccine, bNab-inducing vaccine, Trimer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH505 TF chTrimerBiological
Stabilized CH505 TF chTrimer, 300 mcg
3M-052-AFBiological
3 mcg
Aluminum Hydroxide SuspensionBiological
500 mcg
Sodium Chloride for InjectionOther
Sodium chloride for injection, 0.9% USP volume-matched placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) | Experimental | Not described Receives: Biological: CH505 TF chTrimer; Biological: 3M-052-AF; Biological: Aluminum Hydroxide Suspension |
| Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP) | Placebo comparator | Not described Receives: Other: Sodium Chloride for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who initiated active study treatment (CH505 TF chTrimer, 3M-052-AF and Alum) who met the study-defined primary safety composite endpoint
The study-defined primary safety endpoint is a composite endpoint. A participant who has initiated active study treatment is considered to have met the endpoint if the participant has experienced any treatment-related (i.e., related to CH505 TF chTrimer, 3M-052-AF or Alum as judged by the core team, blinded to study treatment) 1) serious adverse event (SAE), or 2) Grade 3+ adverse event (AE), or 3) AE that led to permanent discontinuation of study treatment regardless of grade
Measured: Day 0 (after initial vaccination) to 4 weeks (28 days) after the last vaccination
Number of the viruses with antibody neutralization response for a cross-clade global panel of 9 viruses expressing heterologous envelopes determined using a neutralization assay
Measured: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
Secondary outcomes (1)
Antibody neutralization response for vaccine-matched and related viruses
Determined using a neutralization assay and CH505 TF and related vaccine matched virus panel
Measured: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion14 Apr 2028 (estimated)
Why it stopped: Temporarily Closed (paused)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Duke University, Access to Advanced Health Institute (AAHI)
- Responsible party
- Sponsor
- Investigators
- Madhu Choudhary, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680479
- Sponsor's protocol ID
- A5422
- Other IDs
- 39037
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT06680479
- Acronym / sponsor ID
- A5422
- Conditions
- HIV-1
- Keywords
- HIV, Therapeutic vaccine, bNab-inducing vaccine, Trimer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily Closed (paused)
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Duke University, Access to Advanced Health Institute (AAHI)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 8 Nov 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.
A5422 is a phase 1, randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, and immunogenicity of a vaccination with stabilized CH505 TF chTrimer admixed with 3M-052-AF + Aluminum hydroxide (Alum), to assess the effect of CH505 TF chTrimer vaccine as a therapeutic vaccine in adults living with HIV-1 on suppressive antiretroviral therapy (ART) with the aim of inducing new HIV-1 Envelope (Env) B-cell neutralizing immune responses. Participants will be on study for up to 100 weeks (52 weeks on study treatment plus 48 weeks follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) | Experimental | Biological: CH505 TF chTrimer, Biological: 3M-052-AF, Biological: Aluminum Hydroxide Suspension |
| Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP) | Placebo comparator | Other: Sodium Chloride for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1 infection
- On a suppressive ART regimen for at least 24 months with no changes in the 90 days prior to study entry
- CD4+ cell count greater than 200 cells/mm3 obtained within 56 days prior to study entry
- HIV-1 RNA <200 copies/mL obtained within 56 days prior to study entry
- Plasma HIV-1 RNA levels <200 copies/mL for at least 12 months on ART prior to study entry
Key exclusion criteria (17 listed)
- Known to have started ART during acute HIV infection
- Known to have HIV-related opportunistic infections within the last 2 years prior to study entry.
- History of malignancy within the last 5 years prior to study entry.
- Currently breastfeeding
- History of or active autoimmune disorders
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 |
|---|---|---|
| CH505 TF chTrimerStabilized CH505 TF chTrimer, 300 mcg | Biological | Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) |
| 3M-052-AF3 mcg | Biological | Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) |
| Aluminum Hydroxide Suspension500 mcg | Biological | Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) |
| Sodium Chloride for InjectionSodium chloride for injection, 0.9% USP volume-matched placebo injection. | Other | Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP) |
Primary outcome
Proportion of participants who initiated active study treatment (CH505 TF chTrimer, 3M-052-AF and Alum) who met the study-defined primary safety composite endpoint
Time frame: Day 0 (after initial vaccination) to 4 weeks (28 days) after the last vaccination
The study-defined primary safety endpoint is a composite endpoint. A participant who has initiated active study treatment is considered to have met the endpoint if the participant has experienced any treatment-related (i.e., related to CH505 TF chTrimer, 3M-052-AF or Alum as judged by the core team, blinded to study treatment) 1) serious adverse event (SAE), or 2) Grade 3+ adverse event (AE), or 3) AE that led to permanent discontinuation of study treatment regardless of grade
Number of the viruses with antibody neutralization response for a cross-clade global panel of 9 viruses expressing heterologous envelopes determined using a neutralization assay
Time frame: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
1 secondary outcome
Antibody neutralization response for vaccine-matched and related viruses
Time frame: Day 0 pre-vaccination to 2 weeks (14 days) after the fifth vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in publication, after deidentification.
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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.
Madhu Choudhary, MD study chair
University of Pittsburgh
24 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 CH505 TF chTrimer, 3M-052-AF and Aluminum Hydroxide Suspension in people with HIV-1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 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 16 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: paused, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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?
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?
Proportion of participants who initiated active study treatment (CH505 TF chTrimer, 3M-052-AF and Alum) who met the study-defined primary safety composite endpoint (time frame: Day 0 (after initial vaccination) to 4 weeks (28 days) after the last vaccination). The study lists 2 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 3 Mar 2026.