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

NCT06812494 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HVTN 206/HPTN 11439137
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 21

Brief 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. 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

Keywords

HIV Prevention; bnAb; Monoclonal antibody; Intravenous; Triple combination; VRC07-523LS; PGT121.414.LS; PGDM1400LS

Outcome Measures

Primary Outcomes (14)

• Number of participants experiencing local Adverse Events (AEs)

  At Days 1, 4, 7, 169 and 173

• Percentage of participants experiencing local AEs

  At Days 1, 4, 7, 169 and 173

• Number of participants experiencing systemic AEs

  At Days 1, 4, 7, 169 and 173

• Percentage of participants experiencing systemic AEs

  At Days 1, 4, 7, 169 and 173

• Number of participants experiencing unsolicited AEs

  Baseline through Week 48

• Percentage of participants experiencing unsolicited AEs

  Baseline through Week 48

• Number of participants experiencing Serious Adverse Events

  Baseline through Week 48

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

  Baseline through Week 48

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

  Baseline through Week 48

• Change from baseline in ALT

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

• Change from baseline in aspartate aminotransferase (AST)

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

• Change from baseline in alkaline phosphatase (Alk Phos)

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

• Change from baseline in creatinine

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

• Change from baseline in Complete Blood Count (CBC)

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

Secondary Outcomes (9)

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

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

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

  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

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

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

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

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

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

Study Arms (2)

Group 1 (400 mg + 400 mg +400 mg)

EXPERIMENTAL

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; Biological: PGT121.414.LS 400mg; Biological: PGDM1400LS 400mg

Group 2 (3200 mg + 1600 mg +1600 mg)

EXPERIMENTAL

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; Biological: PGT121.414.LS 1600mg; Biological: PGDM1400LS 1600mg

Interventions

VRC07-523LS 400mg BIOLOGICAL

Intravenous infusion (IV)

Group 1 (400 mg + 400 mg +400 mg)

PGT121.414.LS 400mg BIOLOGICAL

IV infusion

Group 1 (400 mg + 400 mg +400 mg)

PGDM1400LS 400mg BIOLOGICAL

IV infusion

Group 1 (400 mg + 400 mg +400 mg)

VRC07-523LS 3200mg BIOLOGICAL

IV infusion

Group 2 (3200 mg + 1600 mg +1600 mg)

PGT121.414.LS 1600mg BIOLOGICAL

IV infusion

Group 2 (3200 mg + 1600 mg +1600 mg)

PGDM1400LS 1600mg BIOLOGICAL

IV infusion

Group 2 (3200 mg + 1600 mg +1600 mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institutes of Health (NIH): collaborator
• Department of Health and Human Services: collaborator
• Dale and Betty Bumpers Vaccine Research Center (VRC): collaborator

Study Sites (21)

Alabama CRA (Site #31788)

Birmingham, Alabama, 35222, United States

RECRUITING

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

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

Decatur, Georgia, 30030, United States

RECRUITING

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

Boston, Massachusetts, 02115-6110, United States

RECRUITING

Fenway Health

Boston, Massachusetts, 02215-4302, United States

RECRUITING

BIDMC VCRS (Site ID# 32077)

Boston, Massachusetts, 02215, United States

RECRUITING

Columbia P&S CRS

New York, New York, 10032, United States

RECRUITING

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

Rochester, New York, 14642, United States

RECRUITING

Chapel Hill CRS (Site #3201)

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh CRS (Site 1001)

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, 37232, United States

RECRUITING

Seattle Vaccine and Prevention CRS (Site ID# 30331)

Seattle, Washington, 98104, United States

RECRUITING

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, 21040-360, Brazil

RECRUITING

ACSA CRS

Iquitos, Maynas, 1, Peru

NOT YET RECRUITING

CITBM CRS (Site ID 31970)

Callao, 15081, Peru

RECRUITING

Via Libre (Site ID 31909)

Lima, 15001, Peru

RECRUITING

Perinatal HIV Research Unit (PHRU)

Johannesburg, Gaunteng, 1862, South Africa

NOT YET RECRUITING

Chatsworth CRS

Chatsworth, KwaZulu-Natal, 4030, South Africa

NOT YET RECRUITING

Setshaba Research Centre

Soshanguve-H, Soshanguve, 0152, South Africa

NOT YET RECRUITING

Groote Schuur HIV CRS

Cape Town, Western Cape, 7925, South Africa

NOT YET RECRUITING

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (4); US (13); PE (3); BR (1)