Actively Recruiting
A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-22
83
Participants Needed
12
Research Sites
75 weeks
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
This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together. Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B). Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits. Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.
CONDITIONS
Official 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 length
- Understands the study and willing to give informed consent
- Agrees not to join another experimental study until the final clinic visit
- In good overall health based on medical history, exam, and lab tests
- Willing to receive HIV test results
- Willing to discuss personal HIV risk and have prevention counseling
- Judged to have low risk of getting HIV and agrees to avoid higher risk behaviors
- Hemoglobin: women at least 11.0 g/dL, men at least 13.0 g/dL
- White blood cell count between 2,500 and 12,000 cells/mm³
- White blood cell differential normal or acceptable
- Platelet count between 125,000 and 550,000 cells/mm³
- Liver enzyme ALT less than 1.25 times the lab's upper limit
- Kidney test (creatinine) less than 1.1 times the lab's upper limit
- Negative tests for HIV 1 and HIV 2
- Negative hepatitis B surface antigen
- Negative hepatitis C antibody or negative HCV PCR if antibody positive
- Urine protein negative or trace only
- Women who could become pregnant have a negative pregnancy test within 72 hours before first treatment
- Women able to become pregnant agree to effective birth control starting 21 days before enrollment through last visit
- Women able to become pregnant agree not to attempt pregnancy using methods like egg retrieval or 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 trial (except placebo cases reviewed individually)
- Received any non-HIV vaccine within 14 days before or planned within 14 days after enrollment (exceptions apply)
- Received humanized or human monoclonal antibodies
- Previously received monoclonal antibodies targeting HIV
- Receiving allergy shots within 30 days before first dose or planned within 14 days after
- Took immune suppressing medicines within 30 days before first dose (some exceptions apply)
- History of serious allergic reactions to study product components
- Received immunoglobulin within 60 days before first dose
- Autoimmune disease not mild, stable, and uncomplicated (some mild cases allowed)
- Immunodeficiency
- Significant medical issues or past conditions that affect immune response or study participation safety
- Medical, skin, social, or job conditions that interfere with study participation or consent
- Psychiatric condition preventing study participation (psychosis, recent suicide risk or attempt)
- Currently on tuberculosis treatment
- Asthma more than mild and well controlled
- Diabetes type 1 or type 2 (except diet-controlled type 2 and past gestational diabetes)
- High blood pressure
- Diagnosed bleeding disorder
- Cancer except surgically removed with low risk of recurrence
- Seizure disorder with seizures or treatment in past 3 years
- No functioning spleen (asplenia)
- History of widespread hives, swelling, or anaphylaxis unless due to known trigger avoided for 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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