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

Running, not enrolling · Phase 2

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT06812494

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Starts

2025-03-07

Expected to finish

2027-09-15

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, Rio de Janeiro, Brazil
• Via Libre (Site ID 31909) — Lima, Lima Province, Peru
• ACSA CRS — Iquitos, Maynas, Peru
• CITBM CRS (Site ID 31970) — Callao, Provincia Constitucional del Callao, Peru
• San Miguel CRS (Site #11302) — Lima, Peru
• Perinatal HIV Research Unit (PHRU) — Johannesburg, Gaunteng, South Africa
• Chatsworth CRS — Chatsworth, KwaZulu-Natal, South Africa
• Setshaba Research Centre — Soshanguve-H, Soshanguve, South Africa
• Groote Schuur HIV CRS — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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