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RecruitingNCT07390955Updated Sep 1, 2026

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

A Phase 1 interventional study of ePGT121v1-LS (IV) and PGDM1400LS (IV) in HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 11 sites in 3 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
83
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

02

Conditions studied

  • HIV
03

In context

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 55 years.
  2. Can visit a participating clinic and is willing to stay in the study for its full duration.
  3. Understands the study and is able and willing to give .
  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 lab tests.
  6. Willing to receive test results.
  7. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.
  8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit.

  9. levels:

    • Women: at least 11.0 g/dL
    • Men: at least 13.0 g/dL
  10. White blood cell count between 2,500 and 12,000 cells/mm³.
  11. White blood cell differential is normal or acceptable to clinic staff.
  12. count between 125,000 and 550,000 cells/mm³.
  13. (liver enzyme) less than 1.25 times the lab's .
  14. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.
  15. Negative tests for HIV 1 and HIV 2.
  16. Negative surface antigen.
  17. Negative antibody, or a negative HCV PCR if the antibody test is positive.
  18. Urine protein is negative or only trace.
  19. If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with a documented total hysterectomy, both ovaries removed, both fallopian tubes removed, or menopause (no periods for at least 1 year) do not need pregnancy testing.
  20. Women who could become pregnant agree to use effective for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit.
  21. Women who could become pregnant also agree not to try to become pregnant using methods like egg retrieval, artificial insemination, or in vitro fertilization starting at least 21 days before enrollment and continuing through the last clinic visit.

Exclusion criteria

Exclusion Criteria:

  1. Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).
  2. Took any experimental () research drug within 30 days before the first 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 that requires non Network antibody testing, during this study.
  5. Pregnant or breastfeeding.
  6. Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo/control only, eligibility will be decided case by case by the safety review team.
  7. Received any non HIV vaccine within 14 days before enrollment or plan to get one within 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 days before enrollment (or scab still present if earlier) or planned within 14 days after enrollment.
  8. Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental.
  9. Previously received monoclonal antibodies that target HIV.
  10. Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose.
  11. Took immune suppressing medicines within 30 days before the first study dose. Not excluded: nasal sprays; inhaled steroids (see asthma item); topical steroids for mild skin conditions; or one short course of oral/IV prednisone (less than 20 mg/day for under 14 days) finished at least 7 days before the first infusion/injection.
  12. History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain.
  13. Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above).
  14. disease that is not mild, stable, and uncomplicated. Mild, stable cases not needing immune suppressing drugs may be allowed if the investigator judges low risk.
  15. Immunodeficiency.

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

    • 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 (for example, 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.
  17. Any medical or skin condition, social situation, or job duty that, in the investigator's judgment, would interfere with following the study, safety assessments, or giving .
  18. A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years.
  19. Currently on tuberculosis treatment.
  20. Asthma that is more than mild and well controlled.
  21. Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes.
  22. High blood pressure (hypertension).
  23. Diagnosed bleeding disorder.
  24. Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period.
  25. Seizure disorder with any seizure in the past 3 years, or use of seizure prevention or seizure treatment medicines at any time in the past 3 years.
  26. Asplenia (no functioning spleen).
  27. History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded if due to a known trigger and there have been no reactions for at least 5 years, showing successful avoidance of the trigger.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
83 participants (estimated)

Study arms

  • Experimental
    Part A: Group 1

    ePGT121v1-LS 5 mg/kg to be administered via intravenous (IV) infusion at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV)

  • Experimental
    Part A: Group 2

    ePGT121v1-LS 20 mg/kg to be administered via IV infusion at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV)

  • Experimental
    Part A: Group 3

    ePGT121v1-LS 40 mg/kg to be administered via IV infusion at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV)

  • Experimental
    Part A: Group 4

    ePGT121v1-LS 5 mg/kg + PGDM1400LS 5 mg/kg + VRC07-523LS 5 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV) · Biological: PGDM1400LS (IV) · Biological: VRC07-523LS (IV)

  • Experimental
    Part A: Group 5

    ePGT121v1-LS 20 mg/kg + PGDM1400LS 20 mg/kg + VRC07-523LS 20 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV) · Biological: PGDM1400LS (IV) · Biological: VRC07-523LS (IV)

  • Experimental
    Part A: Group 6

    ePGT121v1-LS 40 mg/kg + PGDM1400LS 40 mg/kg + VRC07-523LS 40 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

    Biological: ePGT121v1-LS (IV) · Biological: PGDM1400LS (IV) · Biological: VRC07-523LS (IV)

  • Experimental
    Part B: Group 7

    ePGT121v1-LS 375 mg (3 injections of 125 mg each) to be administered via subcutaneous (SC) injection at Week 0 and Week 12

    Biological: ePGT121v1-LS (SC)

  • Experimental
    Part B: Group 8

    ePGT121v1-LS 125 mg + PGDM1400LS 100 mg + VRC07-523LS 100 mg to be administered via SC injection sequentially in this order at Week 0 and Week 12

    Biological: ePGT121v1-LS (SC) · Biological: PGDM1400LS (SC) · Biological: VRC07-523LS (SC)

Interventions

06

What researchers measure

Primary outcomes

  1. Part A: Number of participants with solicited local Adverse Events (AEs)

    Time frame: Baseline through Week 48

  2. Part B: Number of participants with solicited local Adverse Events (AEs)

    Time frame: Baseline through Week 24

  3. Part A: Percentage of participants with solicited local Adverse Events (AEs)

    Time frame: Baseline through Week 48

  4. Part B: Percentage of participants with solicited local Adverse Events (AEs)

    Time frame: Baseline through Week 24

  5. Part A: Number of participants with solicited systemic AEs

    Time frame: Baseline through Week 48

  6. Part B: Number of participants with solicited systemic AEs

    Time frame: Baseline through Week 24

  7. Part A: Percentage of participants with solicited systemic AEs

    Time frame: Baseline through Week 48

  8. Part B: Percentage of participants with solicited systemic AEs

    Time frame: Baseline through Week 24

  9. Part A: Percentage of participants with safety laboratory abnormalities meeting grade 1 AE criteria or above

    Time frame: Baseline through Week 48

  10. Part B: Percentage of participants with safety laboratory abnormalities meeting grade 1 AE criteria or above

    Time frame: Baseline through Week 24

  11. Part A: Number of participants with unsolicited AEs

    Time frame: Baseline through Week 48

  12. Part B: Number of participants with unsolicited AEs

    Time frame: Baseline through Week 24

  13. Part A: Percentage of participants with unsolicited AEs

    Time frame: Baseline through Week 48

  14. Part B: Percentage of participants with unsolicited AEs

    Time frame: Baseline through Week 24

  15. Part A: Number of participants with Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 48

  16. Part B: Number of participants with Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 24

  17. Part A: Percentage of participants with Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 48

  18. Part B: Percentage of participants with Serious Adverse Events (SAEs)

    Time frame: Baseline through Week 24

  19. Part A: Number of participants who discontinue study product administration

    Time frame: Baseline through Week 48

  20. Part B: Number of participants who discontinue study product administration

    Time frame: Baseline through Week 24

  21. Part A: Percentage of participants who discontinue study product administration

    Time frame: Baseline through Week 48

  22. Part B: Percentage of participants who discontinue study product administration

    Time frame: Baseline through Week 24

  23. Part A: Number of participants who terminate the study early

    Time frame: Baseline through Week 48

  24. Part B: Number of participants who terminate the study early

    Time frame: Baseline through Week 24

  25. Part A: Percentage of participants who terminate the study early

    Time frame: Baseline through Week 48

  26. Part B: Percentage of participants who terminate the study early

    Time frame: Baseline through Week 24

  27. Part A: Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 48

  28. Part B: Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 24

  29. Part A: Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 48

  30. Part B: Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 24

  31. Part A: Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 48

  32. Part B: Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay

    Time frame: Baseline through Week 24

  33. Part A: Area Under the Concentration-Time Curve (AUC) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  34. Part B: AUC of ePGT121v1-LS

    Time frame: Baseline through Week 24

  35. Part A: AUC of PGDM1400LS

    Time frame: Baseline through Week 48

  36. Part B: AUC of PGDM1400LS

    Time frame: Baseline through Week 24

  37. Part A: AUC of VRC07-523LS

    Time frame: Baseline through Week 48

  38. Part B: AUC of VRC07-523LS

    Time frame: Baseline through Week 24

  39. Part A: Maximum Observed Concentration (Cmax) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  40. Part B: Cmax of ePGT121v1-LS

    Time frame: Baseline through Week 24

  41. Part A: Cmax of PGDM1400LS

    Time frame: Baseline through Week 48

  42. Part B: Cmax of PGDM1400LS

    Time frame: Baseline through Week 24

  43. Part A: Cmax of VRC07-523LS

    Time frame: Baseline through Week 48

  44. Part B: Cmax of VRC07-523LS

    Time frame: Baseline through Week 24

  45. Part A: Time to Maximum Concentration (Tmax) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  46. Part B: Tmax of ePGT121v1-LS

    Time frame: Baseline through Week 24

  47. Part A: Tmax of PGDM1400LS

    Time frame: Baseline through Week 48

  48. Part B: Tmax of PGDM1400LS

    Time frame: Baseline through Week 24

  49. Part A: Tmax of VRC07-523LS

    Time frame: Baseline through Week 48

  50. Part B: Tmax of VRC07-523LS

    Time frame: Baseline through Week 24

  51. Part A: Clearance (CL) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  52. Part B: CL of ePGT121v1-LS

    Time frame: Baseline through Week 24

  53. Part A: CL of PGDM1400LS

    Time frame: Baseline through Week 48

  54. Part B: CL of PGDM1400LS

    Time frame: Baseline through Week 24

  55. Part A: CL of VRC07-523LS

    Time frame: Baseline through Week 48

  56. Part B: CL of VRC07-523LS

    Time frame: Baseline through Week 24

  57. Part A: Volume of Distribution (Vd) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  58. Part B: Vd of ePGT121v1-LS

    Time frame: Baseline through Week 24

  59. Part A: Vd of PGDM1400LS

    Time frame: Baseline through Week 48

  60. Part B: Vd of PGDM1400LS

    Time frame: Baseline through Week 24

  61. Part A: Vd of VRC07-523LS

    Time frame: Baseline through Week 48

  62. Part B: Vd of VRC07-523LS

    Time frame: Baseline through Week 24

  63. Part A: Terminal Elimination Rate Constant (λz) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  64. Part B: λz of ePGT121v1-LS

    Time frame: Baseline through Week 24

  65. Part A: λz of PGDM1400LS

    Time frame: Baseline through Week 48

  66. Part B: λz of PGDM1400LS

    Time frame: Baseline through Week 24

  67. Part A: λz of VRC07-523LS

    Time frame: Baseline through Week 48

  68. Part B: λz of VRC07-523LS

    Time frame: Baseline through Week 24

  69. Part A: Terminal Half-life (T1/2) of ePGT121v1-LS

    Time frame: Baseline through Week 48

  70. Part B: T1/2 of ePGT121v1-LS

    Time frame: Baseline through Week 24

  71. Part A: T1/2 of PGDM1400LS

    Time frame: Baseline through Week 48

  72. Part B: T1/2 of PGDM1400LS

    Time frame: Baseline through Week 24

  73. Part A: T1/2 of VRC07-523LS

    Time frame: Baseline through Week 48

  74. Part B: T1/2 of VRC07-523LS

    Time frame: Baseline through Week 24

  75. Part A: Area Under the Magnitude-Breadth Curve (AUC-MB)

    The AUC-MB to a global panel of pseudoviruses (78) will be computed for each evaluable participant

    Time frame: Baseline through Week 48

  76. Part B: AUC-MB

    The AUC-MB to a global panel of pseudoviruses (78) will be computed for each evaluable participant

    Time frame: Baseline through Week 24

Secondary outcomes

  1. Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  2. Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  3. Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  4. Correlation Between Serum/Plasma Concentration and Serum Neutralization Titer (ID50) for Each Virus

    All participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  5. Correlation Between Serum/Plasma Concentration and Serum Neutralization Titer (ID80) for Each Virus

    All participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  6. Correlation Between Serum/Plasma Concentration and AUC-MB of Serum Neutralization Across the Virus Panel

    All participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  7. Area Under the Magnitude-Breadth Curve (AUC-MB)

    All participants in all groups regardless of how many product administrations and how much product they received

    Time frame: Baseline through Week 48

  8. Population pharmacokinetic (PopPK) modeling of monoclonal antibody (mAb) concentration-time data

    Time frame: Baseline through Week 48

07

Study locations

5 of 11 sites recruiting
  • Alabama CRS (Site ID: 31788)
    Birmingham, Alabama 35222, United States
    Recruiting
  • Bridge HIV CRS (Site ID: 30305)
    San Francisco, California 94102, United States
    Recruiting
  • The Ponce de Leon Center CRS (Site ID: 5802)
    Atlanta, Georgia 30308, United States
    Not yet recruiting
  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
    Boston, Massachusetts 02115, United States
    Not yet recruiting
  • Penn Prevention CRS (Site ID: 30310)
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
    Nashville, Tennessee 37232, United States
    Recruiting
  • Houston Advancing Research Team CRS (Site ID: 31473)
    Houston, Texas 77030, United States
    Recruiting
  • Via Libre CRS (Site ID: 31909)
    Lima Cercado, Lima region 15001, Peru
    Not yet recruiting
  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
    Bellavista, Provincia Constitucional del Callao 07006, Peru
    Not yet recruiting
  • Seke South CRS (Site ID: 30294)
    Harare, Zimbabwe
    Not yet recruiting
  • Spilhaus CRS (Site ID: 30314)
    Harare, Zimbabwe
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2025
First posted
Feb 5, 2026
StartActual
Mar 19, 2026
Primary completionEst.
Aug 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07390955
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Institutes of Health (NIH), Department of Health and Human Services
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Mar 19, 2026
Primary completion
Aug 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: PGDM1400LS · VRC07-523LS

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