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

April 6, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • Recruiting
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
        • Contact:
  • Peru
      • Callao, Peru, 15081
        • Recruiting
        • CITBM CRS (Site ID 31970)
        • Contact:
          • Fanny Rosas Benancio
          • Phone Number: (+51) 1 4800401
          • Email: frosas@citbm.pe
      • Lima, Peru, 15001
        • Recruiting
        • Via Libre (Site ID 31909)
        • Contact:
      • Lima, Peru, 32-15088
        • Recruiting
        • San Miguel CRS (Site #11302)
        • Contact:
    • Maynas
      • Iquitos, Maynas, Peru, 1
        • Not yet recruiting
        • ACSA CRS
        • Contact:
  • South Africa
    • Gaunteng
      • Johannesburg, Gaunteng, South Africa, 1862
        • Not yet recruiting
        • Perinatal HIV Research Unit (PHRU)
        • Contact:
    • KwaZulu-Natal
      • Chatsworth, KwaZulu-Natal, South Africa, 4030
    • Soshanguve
      • Soshanguve-H, Soshanguve, South Africa, 0152
        • Not yet recruiting
        • Setshaba Research Centre
        • Contact:
    • Western Cape
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35222
        • Recruiting
        • Alabama CRA (Site #31788)
        • Contact:
    • California
      • San Francisco, California, United States, 94102
        • Recruiting
        • Bridge HIV, San Francisco Department of Public Health
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • The Hope Clinic of the Emory Vaccine Research Center; Emory University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-6110
        • Recruiting
        • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • BIDMC VCRS (Site ID# 32077)
        • Contact:
      • Boston, Massachusetts, United States, 02215-4302
    • New York
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Chapel Hill CRS (Site #3201)
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh CRS (Site 1001)
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Vaccine (VV) CRS
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Seattle Vaccine and Prevention CRS (Site ID# 30331)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (400 mg + 400 mg +400 mg)
VRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
Biological: VRC07-523LS 400mg
Intravenous infusion (IV)
Biological: PGT121.414.LS 400mg
IV infusion
Biological: PGDM1400LS 400mg
IV infusion
Experimental: Group 2 (3200 mg + 1600 mg +1600 mg)
VRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
Biological: VRC07-523LS 3200mg
IV infusion
Biological: PGT121.414.LS 1600mg
IV infusion
Biological: PGDM1400LS 1600mg
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants experiencing local Adverse Events (AEs)
Time Frame: At Days 1, 4, 7, 169 and 173
At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing local AEs
Time Frame: At Days 1, 4, 7, 169 and 173
At Days 1, 4, 7, 169 and 173
Number of participants experiencing systemic AEs
Time Frame: At Days 1, 4, 7, 169 and 173
At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing systemic AEs
Time Frame: At Days 1, 4, 7, 169 and 173
At Days 1, 4, 7, 169 and 173
Number of participants experiencing unsolicited AEs
Time Frame: Baseline through Week 48
Baseline through Week 48
Percentage of participants experiencing unsolicited AEs
Time Frame: Baseline through Week 48
Baseline through Week 48
Number of participants experiencing Serious Adverse Events
Time Frame: Baseline through Week 48
Baseline through Week 48
Number of participants who discontinue study product administration and terminate the study early
Time Frame: Baseline through Week 48
Baseline through Week 48
Percentage of participants who discontinue study product administration and terminate the study early
Time Frame: Baseline through Week 48
Baseline through Week 48
Change from baseline in ALT
Time Frame: Baseline, Days 1, 57, 169, 225 and 337
Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in aspartate aminotransferase (AST)
Time Frame: Baseline, Days 1, 57, 169, 225 and 337
Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in alkaline phosphatase (Alk Phos)
Time Frame: Baseline, Days 1, 57, 169, 225 and 337
Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in creatinine
Time Frame: Baseline, Days 1, 57, 169, 225 and 337
Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in Complete Blood Count (CBC)
Time Frame: Baseline, Days 1, 57, 169, 225 and 337
Baseline, Days 1, 57, 169, 225 and 337

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Maximum concentration (C(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Time to C(max) (T(max)) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Clearance (CL) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Volume of distribution (Vd) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Terminal elimination rate constant (λz) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Terminal half-life (T1/2) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Area under the magnitude-breadth curve (AUC-MB) of VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 4, 7, 29, 57, 169, 225 and 337
At Days 1, 4, 7, 29, 57, 169, 225 and 337
Presence of antidrug antibodies (ADAs) for VRC07-523LS, PGDM1400LS, and PGT121.414.LS
Time Frame: At Days 1, 169 and 337
At Days 1, 169 and 337

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Institutes of Health (NIH)
Department of Health and Human Services
Dale and Betty Bumpers Vaccine Research Center (VRC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HVTN 206/HPTN 114
  • 39137 (Other Identifier: DAIDS-ES ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on VRC07-523LS 400mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe