Actively Recruiting
A Phase 1 Trial to Evaluate Safety, Drug Levels, and HIV Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adults Without HIV-1
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-22
83
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. This study is testing how safe it is, its side effects, the right dosage, how the body processes it, and how well it neutralizes HIV in the blood. The antibody is studied alone and in combination with two others, VRC07-523LS and PGDM1400LS, which target different parts of the virus. The study involves generally healthy adults without HIV. Participants are divided into two parts. In Part A, six groups receive ePGT121v1-LS by intravenous (IV) infusion at varying doses, either alone or combined with the other two antibodies, with infusions at the start and after 24 weeks. Part B has two groups receiving subcutaneous (SC) injections; one group gets ePGT121v1-LS alone, and the other receives all three antibodies, given twice 12 weeks apart. The study durations are 48 weeks for Part A and 24 weeks for Part B. During the study, participants attend scheduled clinic visits for monitoring. Researchers check for local and systemic side effects, safety lab tests, and measure antibody levels and how they neutralize HIV. They record any adverse events and study how the antibodies behave in the body over time. Participants are observed throughout the study period to assess safety and drug levels.
CONDITIONS
Brief Title
A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years
- Able to visit the clinic and stay in the study for its full duration
- Understands the study and can give informed consent
- Agrees not to join another experimental study until the last clinic visit
- In good overall health based on medical history, physical exam, and lab tests
- Willing to receive HIV test results and counseling
- Judged to have low risk of getting HIV and agrees to avoid higher risk behaviors
- Hemoglobin levels: women at least 11.0 g/dL, men at least 13.0 g/dL
- Normal white blood cell count and differential
- Platelet count between 125,000 and 550,000 cells/mm³
- ALT (liver enzyme) less than 1.25 times upper normal limit
- Creatinine less than 1.1 times upper normal limit
- Negative for HIV 1 and HIV 2
- Negative hepatitis B surface antigen
- Negative hepatitis C antibody or PCR if antibody positive
- Negative or trace urine protein
- Women who could become pregnant have a negative pregnancy test before first treatment
- Women who could become pregnant agree to use effective birth control and avoid pregnancy methods like IVF starting 21 days before enrollment through last visit
You will not qualify if you...
- Received blood products within 120 days before first study dose (unless approved)
- Took experimental research drug within 30 days before first dose
- Weighs less than 35 kg or more than 115 kg
- Plans to join another study with experimental products or non-Network HIV antibody testing during this study
- Pregnant or breastfeeding
- Previously received an HIV vaccine in a vaccine trial (placebo cases reviewed individually)
- Received non-HIV vaccine within 14 days before or planned within 14 days after enrollment (some exceptions)
- Received humanized or human monoclonal antibodies
- Previously received monoclonal antibodies targeting HIV
- Receiving allergy shots near dosing time
- Took immune suppressing medicines within 30 days before first dose (with some exceptions)
- History of serious allergic reactions to study products
- Received immunoglobulin within 60 days before first dose
- Autoimmune disease not mild, stable, and uncomplicated
- Immunodeficiency
- Medical issues or conditions that affect immune response or safety of injections
- Psychiatric conditions preventing study compliance
- Currently on tuberculosis treatment
- Asthma more than mild and well controlled
- Diabetes (except type 2 controlled by diet or past gestational diabetes)
- High blood pressure
- Diagnosed bleeding disorder
- Cancer with high risk of recurrence during study
- Seizure disorder with recent seizures or treatment
- Asplenia (no functioning spleen)
- History of widespread hives, swelling, or anaphylaxis unless no reactions for 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks depending on group assignment
Participants receive intravenous or subcutaneous infusions of study drugs at specified intervals.
2 infusion visits at Week 0 and Week 24 for intravenous groups; 2 injection visits at Week 0 and Week 12 for subcutaneous groups
Duration - Up to 48 weeks for Part A participants and up to 24 weeks for Part B participants
Participants are monitored for safety, drug levels, and adverse events after treatment.
Regular visits for safety and drug monitoring through Week 48 for Part A; through Week 24 for Part B
Trial Site Locations
Total: 12 locations
1
Alabama CRS (Site ID: 31788)
Birmingham, Alabama, United States, 35222
Actively Recruiting
2
Bridge HIV CRS (Site ID: 30305)
San Francisco, California, United States, 94102
Actively Recruiting
3
George Washington University CRS (Site ID: 31608)
Washington D.C., District of Columbia, United States, 20052
Not Yet Recruiting
4
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
5
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
6
Penn Prevention CRS (Site ID: 30310)
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Houston Advancing Research Team CRS (Site ID: 31473)
Houston, Texas, United States, 77030
Not Yet Recruiting
9
Via Libre CRS (Site ID: 31909)
Lima Cercado, Lima region, Peru, 15001
Not Yet Recruiting
10
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
Bellavista, Provincia Constitucional del Callao, Peru, 07006
Not Yet Recruiting
11
Seke South CRS (Site ID: 30294)
Harare, Zimbabwe
Not Yet Recruiting
12
Spilhaus CRS (Site ID: 30314)
Harare, Zimbabwe
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
8
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