HIV InfectionsPhase 1NETINCT04985760

Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy

A Phase 1 study testing Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant and Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant in people with HIV Infections, run by Madhu Chhanda Choudhary at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant and Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: 30 Sep 2021to 16 Jan 2026
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, documented by any FDA-approved assay. NOTE: The term 'licensed' refers to a US FDA approved kit, which is required for all investigational new drug (IND) studies.
Receiving continuous antiretroviral therapy (ART) for at least 24 months (defined as no interruptions longer than 30 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry. A change in formulation (for example tenofovir disaproxil fumarate to tenofovir alafenamide) will not be considered a change in ART.
Screening CD4+ cell count ≥200cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
Plasma HIV-1 RNA levels < 50 copies/ml for at least 24 months on ART prior to study entry using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent. Participants must have at least one documented HIV-1 RNA < 50 copies/ml within 12 months prior to study entry. All available HIV-1 RNA measurements must be < 50 copies/ml during the 24 months prior to study entry except as allowed by the following note.
NOTE: Unconfirmed plasma HIV-1 RNA > 50 copies/ml but <200 copies/mL is allowed if followed by a subsequent value < 50 copies/ml.
Screening HIV-1 RNA levels <50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 60 days prior to entry.

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Men and women ages > 18 years.
The following laboratory values obtained within 60 days prior to entry:
Hemoglobin ≥10 g/dL
Absolute neutrophil count (ANC) ≥1000/mm3
Platelet count ≥100,000/mm3
Creatinine ≤ 1.5x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤2.5x ULN
Ability and willingness of participant to provide informed consent.
In the opinion of the investigator, no medical, mental health or other condition that precludes participation.
For persons who can become pregnant, negative serum or urine pregnancy test within 48 hours prior to entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point-of-care (POC)/ CLIA-waived test. Persons who can become pregnant include women who have not been post-menopausal for at least 12 consecutive months, (i.e., who have had menses within the preceding 12 months) or women who have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation or salpingectomy). Self- report is acceptable documentation of menopause and sterilization.
All participants must agree not to participate in the conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the participant/partner must use at least one reliable form of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormone-based contraceptive), while receiving study treatment and for 12 weeks following the final study vaccine.

Who cannot join

Known to have been started on antiretroviral therapy within 3 months of the presumed or known date of first acquiring HIV-1 infection; i.e., treated during acute HIV-1 infection
Currently breastfeeding or pregnant
Known allergy/sensitivity or any hypersensitivity to components of study vaccine or their formulation.
Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry.

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Use of systemic immunomodulators (e.g., interleukins, interferons, Cyclosporine), systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry.
NOTE: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone ≤10 mg/day, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids, or topical imiquimod will not be excluded.
Receipt of any investigational HIV immunotherapy or HIV therapeutic vaccination within 12 months prior to study entry.
History of positive HCV antibody with detectable HCV RNA in plasma within 48 Weeks prior to study entry. NOTE: Persons with positive HCV Ab but negative plasma HCV RNA are allowed to participate. Sites must document negative HCV RNA within 24 weeks of study entry.
Treatment for hepatitis C within 6 months prior to study entry.
History of positive HBsAg within 48 weeks prior to study entry.
History of severe reaction or anaphylaxis to prior vaccinations.
Body Mass Index >40kg/m2.
Receipt of Blood products or immune globulins within 16 weeks prior to Enrollment as per protocol section 5.3.2.
Receipt of Live attenuated vaccines within 4 weeks prior to enrollment.
Current allergen immunotherapy with antigen injections, unless on maintenance schedule.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

AIDS Clinical Trials Unit/The Ohio State University
Columbus, Ohio, 43210
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) Vaccine, in HIV-1 Infected Adults on Suppressive ART

Trimer 4571 is a vaccine designed to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV. Trimer 4571 is investigational, meaning it is not approved by the US Food and Drug Administration (FDA). There is limited human experience with the Trimer 4571 vaccine administered with aluminum hydroxide (alum) and the vaccine has not been tested in people with HIV prior to this study although it has been tested in healthy volunteers. The goal of this study is to see if Trimer 4571 is safe and well tolerated and to see if it will help the immune system produce bnAbs against HIV.

Read the detailed description

The immune system is composed of special cells, proteins, tissues, and organs that protect against germs and microorganisms and is the body's defense against infections. Antibodies are a type of protein that helps the body fight infection and are usually made by a person's own immune system. A type of antibody that can recognize and block many types of HIV from entering healthy cells are called broadly neutralizing antibodies, or 'bnAbs', and may also activate other immune cells to help destroy HIV-infected cells. Research has shown that people with HIV who develop bnAbs against the virus are better able to control the infection. While the immune systems of some people with HIV show signs of early bnAb production, only a small percentage of people with HIV naturally develop bnAbs.

Approximately 32 participants will be sequentially enrolled and randomized 3:1 by chance like rolling dice to receive either the Trimer 4571 vaccine or a placebo vaccine that does not contain Trimer 4571.

Participants will be asked to attend 11 study visits over a period of approximately 50 weeks and receive 3 doses of their assigned study vaccine: one at Entry, one at Week 8 and one at Week 20. Researchers will compare the results from participants who get the Trimer 4571 vaccine with results from participants who get the placebo vaccine. Participants, the researchers and the clinic staff will not know which vaccine participants are getting.

After Week 20, participants will be followed for 24 additional weeks with study visits and tests to monitor their health and safety and to see how the study vaccine affects the immune system and the virus.

Conditions: HIV Infections
Being tested: Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant, Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant, Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant, Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant
Keywords: HIV, Vaccine, Vaccination, Immune system, Antibody, Antibodies, broadly neutralizing, bnabs
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantBiological
Also called HIV-1 Trimer 4571 Vaccine, VRC-HIVRGP096-00-VP
Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantBiological
Also called Phosphate buffered saline
Volume matched control for Trimer 4571 vaccine 100mcg
Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantBiological
Also called HIV-1 Trimer 4571 Vaccine, VRC-HIVRGP096-00-VP
Investigational vaccine composed of Trimer 4571 500mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantBiological
Also called Phosphate buffered saline
Volume matched control for Trimer 4571 vaccine 500mcg

Study groups in NCT04985760
Study group	Role	What they receive
Randomized Blinded Trimer 4571 Vaccine 100mcg	Experimental	Six (6) participants will receive Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant as a 1ml intramuscular injection at Day 0, Week 8 and Week 20. Receives: Biological: Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant
Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcg	Placebo comparator	Two (2) participants will receive the placebo control for Trimer 4571 vaccine 100mcg as a 1ml intramuscular injection at Day 0, Week 8 and Week 20. Receives: Biological: Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant
Randomized Blinded Trimer 4571 Vaccine 500mcg	Experimental	Eighteen (18) participants will receive Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20. Receives: Biological: Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant
Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcg	Placebo comparator	Six (6) participants will receive the placebo control for Trimer 4571 vaccine 500mcg as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20. Receives: Biological: Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
The proportion of participants experiencing at least one Grade 3 or higher adverse event will be summarized within and across the Trimer 4571 vaccine 100mcg, Trimer 4571 vaccine 500mcg and placebo control vaccine groups. The number of adverse events in each group will also be summarized by severity, body system, and relationship to study vaccine using frequencies, percent, and 95% confidence intervals.
Measured: Day 0 through Week 44

Secondary outcomes (1)

Immunogenicity of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
Comparison of the change in the serum ID50 neutralization titer of BG505.W6M.C2 virus between Trimer 4571 vaccine 100mcg, Trimer 4571 vaccine 500mcg, and placebo control vaccine. Vaccine responders will be as defined by either (i) 4-fold increase in neutralization titer from pre-vaccination to at least one virus in the curated virus panel at any protocol-specified time point post vaccination and/or (ii) Evidence of BG505.W2 neutralization at any protocol-specified time point post vaccination.
Measured: Baseline and Week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202116 Jan 2026

First posted2 Aug 2021
Study start30 Sep 2021
Primary completion16 Jan 2026
Study completion16 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies 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: Sequential
Model description: Randomized, double-blind, dose escalation
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04985760
Sponsor's protocol ID: DAIDS-ES 38763
Other IDs: U01AI152969
Acronym: NETI
Status last verified: Jan 2026
First submitted: 21 Jul 2021
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) Vaccine, in HIV-1 Infected Adults on Suppressive ART
ClinicalTrials.gov ID: NCT04985760
Acronym / sponsor ID: NETI / DAIDS-ES 38763
Conditions: HIV Infections
Keywords: HIV, Vaccine, Vaccination, Immune system, Antibody, Antibodies, broadly neutralizing, bnabs
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Madhu Chhanda ChoudharyUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 30 Sep 2021 (actual)
Primary completion: 16 Jan 2026 (actual)
Study completion: 16 Jan 2026 (actual)
First posted: 2 Aug 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Randomized, double-blind, dose escalation

Arm	Type	Receives
Randomized Blinded Trimer 4571 Vaccine 100mcg	Experimental	Biological: Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantSix (6) participants will receive Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.
Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcg	Placebo comparator	Biological: Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantTwo (2) participants will receive the placebo control for Trimer 4571 vaccine 100mcg as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.
Randomized Blinded Trimer 4571 Vaccine 500mcg	Experimental	Biological: Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantEighteen (18) participants will receive Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.
Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcg	Placebo comparator	Biological: Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantSix (6) participants will receive the placebo control for Trimer 4571 vaccine 500mcg as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

HIV-1 infection, documented by any FDA-approved assay. NOTE: The term 'licensed' refers to a US FDA approved kit, which is required for all investigational new drug (IND) studies.
Receiving continuous antiretroviral therapy (ART) for at least 24 months (defined as no interruptions longer than 30 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry. A change in formulation (for example tenofovir disaproxil fumarate to tenofovir alafenamide) will not be considered a change in ART.
Screening CD4+ cell count ≥200cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
Plasma HIV-1 RNA levels < 50 copies/ml for at least 24 months on ART prior to study entry using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent. Participants must have at least one documented HIV-1 RNA < 50 copies/ml within 12 months prior to study entry. All available HIV-1 RNA measurements must be < 50 copies/ml during the 24 months prior to study entry except as allowed by the following note.
NOTE: Unconfirmed plasma HIV-1 RNA > 50 copies/ml but <200 copies/mL is allowed if followed by a subsequent value < 50 copies/ml.

Key exclusion criteria (17 listed)

Known to have been started on antiretroviral therapy within 3 months of the presumed or known date of first acquiring HIV-1 infection; i.e., treated during acute HIV-1 infection
Currently breastfeeding or pregnant
Known allergy/sensitivity or any hypersensitivity to components of study vaccine or their formulation.
Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

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
Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantAlso: HIV-1 Trimer 4571 Vaccine, VRC-HIVRGP096-00-VPInvestigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent	Biological	Randomized Blinded Trimer 4571 Vaccine 100mcg
Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvantAlso: Phosphate buffered salineVolume matched control for Trimer 4571 vaccine 100mcg	Biological	Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcg
Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantAlso: HIV-1 Trimer 4571 Vaccine, VRC-HIVRGP096-00-VPInvestigational vaccine composed of Trimer 4571 500mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent	Biological	Randomized Blinded Trimer 4571 Vaccine 500mcg
Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvantAlso: Phosphate buffered salineVolume matched control for Trimer 4571 vaccine 500mcg	Biological	Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcg

Primary outcome

Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
Time frame: Day 0 through Week 44
The proportion of participants experiencing at least one Grade 3 or higher adverse event will be summarized within and across the Trimer 4571 vaccine 100mcg, Trimer 4571 vaccine 500mcg and placebo control vaccine groups. The number of adverse events in each group will also be summarized by severity, body system, and relationship to study vaccine using frequencies, percent, and 95% confidence intervals.

1 secondary outcome

Immunogenicity of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
Time frame: Baseline and Week 22

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Individual participant dataSharing planned: No

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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 principal investigator

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART (time frame: Day 0 through Week 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04985760.

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 22 Jan 2026.