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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

A Randomized, Double Blind, Controlled, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV (NCT06812494) is a Phase 2 interventional studying HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HIV and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants need to be between 18 and 65 years old. - Participants must have access to a participating clinical research site and be willing to follow the study schedule. - Participants should understand the study details and be willing to give willing to sign a consent form. - Participants must agree not to join any other clinical trials until they finish this study. - Participants must be willing to receive HIV test results. - Participants should be open to discussing HIV prevention. - Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study. - Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status. - White Blood Cells (WBC): Should be within the normal range or approved by a site clinician. - Platelets: At least 100,000 cells/mm³. - Alanine aminotransferase (ALT): Less than 5 times the upper normal limit. - Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level. - Participants must test negative for HIV-1 and HIV-2. - Participants urine protein must be negative or trace. Reproductive Status: - Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study. - Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study. - Participants must agree not to try to become pregnant through any method during the study. Who Should NOT Join This Trial: - Participants cannot have had a blood transfusion within the last 120 days. - Participants cannot have received experimental treatments within the last 30 days. - Participants cannot weigh less than 35 kg (about 77 lbs). - Participants cannot plan to join another clinical trial during this study. - Participants cannot be pregnant or breastfeeding. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants need to be between 18 and 65 years old. * Participants must have access to a participating clinical research site and be willing to follow the study schedule. * Participants should understand the study details and be willing to give informed consent. * Participants must agree not to join any other clinical trials until they finish this study. * Participants must be willing to receive HIV test results. * Participants should be open to discussing HIV prevention. * Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study. * Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status. * White Blood Cells (WBC): Should be within the normal range or approved by a site clinician. * Platelets: At least 100,000 cells/mm³. * Alanine aminotransferase (ALT): Less than 5 times the upper normal limit. * Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level. * Participants must test negative for HIV-1 and HIV-2. * Participants urine protein must be negative or trace. Reproductive Status: * Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study. * Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study. * Participants must agree not to try to become pregnant through any method during the study. Exclusion Criteria: * Participants cannot have had a blood transfusion within the last 120 days. * Participants cannot have received experimental treatments within the last 30 days. * Participants cannot weigh less than 35 kg (about 77 lbs). * Participants cannot plan to join another clinical trial during this study. * Participants cannot be pregnant or breastfeeding. * Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval). * Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days. * Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago. * Participants cannot have had allergy shots within the last 14 days. * Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments. * Participants cannot participate if they have had serious allergic reactions to the components of the study product. * Participants cannot have received immunoglobulin within the last 60 days. * Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable. * Participants cannot have an immune system deficiency. * Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study. * Participants cannot have conditions that make repeated injections or blood draws difficult. * Participants cannot have conditions requiring active medical treatment that could pose a risk during the study. * Participants cannot have conditions that could be confused with reactions to the study product. * Participants cannot have medical, social, or occupational conditions that would interfere with the study. * Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts. * Participants cannot be undergoing treatment for tuberculosis. * Participants cannot have severe asthma that requires frequent medication or emergency care. * Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary). * Participants blood pressure must be below 160/110 mmHg. * Participants cannot have any diagnosed bleeding disorders. * Participants cannot have active cancer but may be eligible if, in the investigator's estimation, they have a reasonable assurance of sustained cure, or are unlikely to experience recurrence of malignancy during the period of the study * Participants cannot have had seizures or taken seizure medications in the past 3 years. * Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years. * Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.

Treatments Being Tested

BIOLOGICAL

VRC07-523LS 400mg

Intravenous infusion (IV)

BIOLOGICAL

PGT121.414.LS 400mg

IV infusion

BIOLOGICAL

PGDM1400LS 400mg

IV infusion

BIOLOGICAL

VRC07-523LS 3200mg

IV infusion

BIOLOGICAL

PGT121.414.LS 1600mg

IV infusion

BIOLOGICAL

PGDM1400LS 1600mg

IV infusion

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Alabama CRA (Site #31788)
Birmingham, Alabama, United States
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health
Boston, Massachusetts, United States
BIDMC VCRS (Site ID# 32077)
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester, New York, United States
Chapel Hill CRS (Site #3201)
Chapel Hill, North Carolina, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS (Site 1001)
Pittsburgh, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle, Washington, United States
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil
ACSA CRS
Iquitos, Maynas, Peru
CITBM CRS (Site ID 31970)
Callao, Peru
Via Libre (Site ID 31909)
Lima, Peru
San Miguel CRS (Site #11302)
Lima, Peru
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gaunteng, South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06812494), the sponsor (National Institute of Allergy and Infectious Diseases (NIAID)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06812494 clinical trial studying?

HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an e… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06812494?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06812494?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06812494. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06812494. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.