NCT06812494 · National Institute of Allergy and Infectious Diseases (NIAID)
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
What this study is about
HVTN 206/HPTN 114 is a randomly assigned, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, how the drug moves through the body, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given given through a vein (IV) in adult participants without HIV.
View original scientific description
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.
Interventions
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
Primary outcome measures
Number of participants experiencing local Adverse Events (AEs)
Time frame: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing local AEs
Time frame: At Days 1, 4, 7, 169 and 173
Number of participants experiencing systemic AEs
Time frame: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing systemic AEs
Time frame: At Days 1, 4, 7, 169 and 173
Number of participants experiencing unsolicited AEs
Time frame: Baseline through Week 48
Percentage of participants experiencing unsolicited AEs
Time frame: Baseline through Week 48
Number of participants experiencing Serious Adverse Events
Time frame: Baseline through Week 48
Number of participants who discontinue study product administration and terminate the study early
Time frame: Baseline through Week 48
Percentage of participants who discontinue study product administration and terminate the study early
Time frame: Baseline through Week 48
Change from baseline in ALT
Time frame: 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
Change from baseline in alkaline phosphatase (Alk Phos)
Time frame: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in creatinine
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 t
Where
- Birmingham, Alabama
- San Francisco, California
- Decatur, Georgia
- Boston, Massachusetts
- New York, New York
- Rochester, New York
- Chapel Hill, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Seattle, Washington
Collaborators
National Institutes of Health (NIH), Department of Health and Human Services, Dale and Betty Bumpers Vaccine Research Center (VRC)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations