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HIVPhase 2NCT06812494

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

A Phase 2 study testing VRC07-523LS 400mg, PGT121.414.LS 400mg and PGDM1400LS 400mg in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
VRC07-523LS 400mg, PGT121.414.LS 400mg and PGDM1400LS 400mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
17 sitesin 3 countries
Study dates
7 Mar 2025to 15 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 cannot join

  • 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).
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  • 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.

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

United States13 sites

  • Alabama CRA (Site #31788)

    Birmingham, Alabama, 35222

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

    Boston, Massachusetts, 02115-6110

  • Fenway Health

    Boston, Massachusetts, 02215-4302

  • BIDMC VCRS (Site ID# 32077)

    Boston, Massachusetts, 02215

  • Chapel Hill CRS (Site #3201)

    Chapel Hill, North Carolina, 27599

  • The Hope Clinic of the Emory Vaccine Research Center; Emory University

    Decatur, Georgia, 30030

  • Vanderbilt Vaccine (VV) CRS

    Nashville, Tennessee, 37232

  • Columbia P&S CRS

    New York, New York, 10032

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS (Site 1001)

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)

    Rochester, New York, 14642

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California, 94102

  • Seattle Vaccine and Prevention CRS (Site ID# 30331)

    Seattle, Washington, 98104

Other trials in United States

Peru3 sites

  • CITBM CRS (Site ID 31970)

    Callao, Provincia Constitucional del Callao, 15081

  • Via Libre (Site ID 31909)

    Lima, Lima Province, 15001

  • San Miguel CRS (Site #11302)

    Lima, 32-15088

Other trials in Peru

Brazil1 site

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio de Janeiro, Rio de Janeiro, 21040-360

Other trials in Brazil

About this study

Official title: 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

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.

Conditions
HIV
Being tested
VRC07-523LS 400mg, PGT121.414.LS 400mg, PGDM1400LS 400mg, VRC07-523LS 3200mg, PGT121.414.LS 1600mg
Keywords
HIV Prevention, bnAb, Monoclonal antibody, Intravenous, Triple combination, VRC07-523LS, PGT121.414.LS, PGDM1400LS

What participants receive

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

  • VRC07-523LS 400mgBiological

    Intravenous infusion (IV)

  • PGT121.414.LS 400mgBiological

    IV infusion

  • PGDM1400LS 400mgBiological

    IV infusion

  • VRC07-523LS 3200mgBiological

    IV infusion

  • PGT121.414.LS 1600mgBiological

    IV infusion

  • PGDM1400LS 1600mgBiological

    IV infusion

Study groups in NCT06812494
Study groupRoleWhat they receive
Group 1 (400 mg + 400 mg +400 mg)ExperimentalVRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
Receives: Biological: VRC07-523LS 400mg; Biological: PGT121.414.LS 400mg; Biological: PGDM1400LS 400mg
Group 2 (3200 mg + 1600 mg +1600 mg)ExperimentalVRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
Receives: Biological: VRC07-523LS 3200mg; Biological: PGT121.414.LS 1600mg; Biological: PGDM1400LS 1600mg

What is being measured

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

  1. Number of participants experiencing local Adverse Events (AEs)

    Measured: At Days 1, 4, 7, 169 and 173

  2. Percentage of participants experiencing local AEs

    Measured: At Days 1, 4, 7, 169 and 173

  3. Number of participants experiencing systemic AEs

    Measured: At Days 1, 4, 7, 169 and 173

  4. Percentage of participants experiencing systemic AEs

    Measured: At Days 1, 4, 7, 169 and 173

  5. Number of participants experiencing unsolicited AEs

    Measured: Baseline through Week 48

  6. Percentage of participants experiencing unsolicited AEs

    Measured: Baseline through Week 48

  7. Number of participants experiencing Serious Adverse Events

    Measured: Baseline through Week 48

  8. Number of participants who discontinue study product administration and terminate the study early

    Measured: Baseline through Week 48

  9. Percentage of participants who discontinue study product administration and terminate the study early

    Measured: Baseline through Week 48

  10. Change from baseline in ALT

    Measured: Baseline, Days 1, 57, 169, 225 and 337

  11. Change from baseline in aspartate aminotransferase (AST)

    Measured: Baseline, Days 1, 57, 169, 225 and 337

  12. Change from baseline in alkaline phosphatase (Alk Phos)

    Measured: Baseline, Days 1, 57, 169, 225 and 337

  13. Change from baseline in creatinine

    Measured: Baseline, Days 1, 57, 169, 225 and 337

  14. Change from baseline in Complete Blood Count (CBC)

    Measured: Baseline, Days 1, 57, 169, 225 and 337

Secondary outcomes (9)

  1. Area under the curve (AUC) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  2. Maximum concentration (C(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  3. Time to C(max) (T(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  4. Clearance (CL) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  5. Volume of distribution (Vd) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  6. Terminal elimination rate constant (λz) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  7. Terminal half-life (T1/2) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  8. Area under the magnitude-breadth curve (AUC-MB) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 4, 7, 29, 57, 169, 225 and 337

  9. Presence of antidrug antibodies (ADAs) for VRC07-523LS, PGDM1400LS, and PGT121.414.LS

    Measured: At Days 1, 169 and 337

Timeline

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

  1. First posted6 Feb 2025
  2. Study start7 Mar 2025
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812494
Sponsor's protocol ID
HVTN 206/HPTN 114
Other IDs
39137
Status last verified
Jul 2026
First submitted
31 Jan 2025
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VRC07-523LS 400mg, PGT121.414.LS 400mg and PGDM1400LS 400mg in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in 3 countries.

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 18 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Peru, Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 experiencing local Adverse Events (AEs) (time frame: At Days 1, 4, 7, 169 and 173). The study lists 14 primary outcomes in all. 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 NCT06812494.

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 21 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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