A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

Last updated: April 13, 2026
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv

Treatment

PGDM1400LS (SC)

ePGT121v1-LS (IV)

ePGT121v1-LS (SC)

Clinical Study ID

NCT07390955
HVTN 141/HPTN 105
38950
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 to 55 years.

  2. Can visit a participating clinic and is willing to stay in the study for its fullduration.

  3. Understands the study and is able and willing to give informed consent.

  4. Agrees not to join another experimental study until the final required clinic visit.

  5. In good overall health based on medical history, physical exam, and screening labtests.

  6. Willing to receive HIV test results.

  7. Willing to discuss personal risk of getting HIV and to have HIV preventioncounseling.

  8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higherrisk behaviors through the last clinic visit.

  9. Hemoglobin levels:

  • Women: at least 11.0 g/dL

  • Men: at least 13.0 g/dL

  1. White blood cell count between 2,500 and 12,000 cells/mm³.

  2. White blood cell differential is normal or acceptable to clinic staff.

  3. Platelet count between 125,000 and 550,000 cells/mm³.

  4. ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal.

  5. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.

  6. Negative tests for HIV 1 and HIV 2.

  7. Negative hepatitis B surface antigen.

  8. Negative hepatitis C antibody, or a negative HCV PCR if the antibody test ispositive.

  9. Urine protein is negative or only trace.

  10. If a woman who could become pregnant: negative pregnancy test within 72 hours beforethe first study treatment. Women with a documented total hysterectomy, both ovariesremoved, both fallopian tubes removed, or menopause (no periods for at least 1 year)do not need pregnancy testing.

  11. Women who could become pregnant agree to use effective birth control for sex thatcould lead to pregnancy starting at least 21 days before enrollment and continuingthrough the last study visit.

  12. Women who could become pregnant also agree not to try to become pregnant usingmethods like egg retrieval, artificial insemination, or in vitro fertilizationstarting at least 21 days before enrollment and continuing through the last clinicvisit.

Exclusion

Exclusion Criteria:

  1. Received blood products within 120 days before the first study dose (unless thesafety review team approves earlier enrollment).

  2. Took any experimental (investigational) research drug within 30 days before thefirst study dose.

  3. Weighs less than 35 kg or more than 115 kg.

  4. Plans to join another study using an experimental product, or any study thatrequires non Network HIV antibody testing, during this study.

  5. Pregnant or breastfeeding.

  6. Previously received an HIV vaccine in a vaccine trial. If a potential participantreceived placebo/control only, eligibility will be decided case by case by thesafety review team.

  7. Received any non HIV vaccine within 14 days before enrollment or plan to get onewithin 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 daysbefore enrollment (or scab still present if earlier) or planned within 14 days afterenrollment.

  8. Received humanized or human monoclonal antibodies (mAbs), whether approved orexperimental.

  9. Previously received monoclonal antibodies that target HIV.

  10. Receiving allergy shots within 30 days before the first study dose or scheduledwithin 14 days after the first dose.

  11. Took immune suppressing medicines within 30 days before the first study dose. Notexcluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroidsfor mild skin conditions; or one short course of oral/IV prednisone (less than 20mg/day for under 14 days) finished at least 7 days before the firstinfusion/injection.

  12. History of serious reactions to components of the study products, includinganaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), orabdominal pain.

  13. Received immunoglobulin within 60 days before the first study dose (separate frommAbs listed above).

  14. Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable casesnot needing immune suppressing drugs may be allowed if the investigator judges lowrisk.

  15. Immunodeficiency.

  16. Any significant medical issue, abnormal exam or lab result, or past condition thatcould:

  • Affect the immune system or its response,

  • Require medicines that affect the immune system,

  • Make repeated injections, infusions, or blood draws unsafe or not feasible (forexample, very difficult veins),

  • Need active medical care to prevent serious harm during the study,

  • Have symptoms that could be mistaken for reactions to the study product,

  • Or is otherwise listed among these exclusions.

  1. Any medical or skin condition, social situation, or job duty that, in theinvestigator's judgment, would interfere with following the study, safetyassessments, or giving informed consent.

  2. A psychiatric condition that prevents following the study. Specifically excluded:psychosis, current suicide risk, or a suicide attempt within the past 3 years.

  3. Currently on tuberculosis treatment.

  4. Asthma that is more than mild and well controlled.

  5. Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or apast history of gestational diabetes.

  6. High blood pressure (hypertension).

  7. Diagnosed bleeding disorder.

  8. Cancer. Not excluded: surgically removed cancers with good assurance of cure or verylow risk of recurrence during the study period.

  9. Seizure disorder with any seizure in the past 3 years, or use of seizure preventionor seizure treatment medicines at any time in the past 3 years.

  10. Asplenia (no functioning spleen).

  11. History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded ifdue to a known trigger and there have been no reactions for at least 5 years,showing successful avoidance of the trigger.

Study Design

Total Participants: 83
Treatment Group(s): 6
Primary Treatment: PGDM1400LS (SC)
Phase: 1
Study Start date:
March 19, 2026
Estimated Completion Date:
August 30, 2027

Connect with a study center

  • Via Libre CRS (Site ID: 31909)

    Lima Cercado, Lima region 15001
    Peru

    Site Not Available

  • Via Libre CRS (Site ID: 31909)

    Lima Cercado 9863490, Lima region 3936452 15001
    Peru

    Site Not Available

  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)

    Bellavista, Provincia Constitucional del Callao 07006
    Peru

    Site Not Available

  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)

    Bellavista 3946756, Provincia Constitucional del Callao 3946080 07006
    Peru

    Site Not Available

  • Alabama CRS (Site ID: 31788)

    Birmingham, Alabama 35222
    United States

    Active - Recruiting

  • Alabama CRS (Site ID: 31788)

    Birmingham 4049979, Alabama 4829764 35222
    United States

    Site Not Available

  • Bridge HIV CRS (Site ID: 30305)

    San Francisco, California 94102
    United States

    Active - Recruiting

  • Bridge HIV CRS (Site ID: 30305)

    San Francisco 5391959, California 5332921 94102
    United States

    Site Not Available

  • George Washington University CRS (Site ID: 31608)

    Washington D.C., District of Columbia 20052
    United States

    Site Not Available

  • George Washington University CRS (Site ID: 31608)

    Washington D.C. 4140963, District of Columbia 4138106 20052
    United States

    Site Not Available

  • The Ponce de Leon Center CRS (Site ID: 5802)

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • The Ponce de Leon Center CRS (Site ID: 5802)

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Site Not Available

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Penn Prevention CRS (Site ID: 30310)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Penn Prevention CRS (Site ID: 30310)

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Vanderbilt Vaccine (VV) CRS (Site ID: 30352)

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt Vaccine (VV) CRS (Site ID: 30352)

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Houston Advancing Research Team CRS (Site ID: 31473)

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Advancing Research Team CRS (Site ID: 31473)

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.