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NCT02599896 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02599896: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02599896 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02599896, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Background: Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses. Researchers want to see if it does this in people. Objectives: To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is maintained in people and if they develop an immune response to it. Eligibility: Healthy people ages 18 to 50 Design: Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical history, physical exam, and blood and urine tests. The study will last 24 to 48 weeks. Visits will last 2 to 8 hours. Participants will get VRC01LS through either: * A needle in an arm vein or * A small needle placed into the fatty tissue under the skin of the abdomen, thigh, or arm. Participants will be assigned to 1 of 6 groups. Groups 1 to 4 will get 1 dose of VRC01LS. They will have follow-up visits through week 24. Groups 5 and 6 will get 1 dose of VRC01LS every 12 weeks (3 doses). They will have 4 to 5 visits between the second and third dose, and follow-up visits through week 48. Participants will have 1 to 3 follow-up visits in the week after receiving VRC01LS. They will record their temperature and keep a diary of symptoms for 3 days after a dose. They may have additional unscheduled visits. At each visit, participants will have a physical exam and may have blood and urine tests.
Interventions
- BIOLOGICAL VRC-HIVMAB080-00-AB (VRC01LS)
- BIOLOGICAL VRC-HIVMAB060-00-AB (VRC01)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2018-07-25 |
| Phase | Phase 1 |
What the finished NCT02599896 record still lists
NCT02599896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which VRC-HIVMAB080-00-AB (VRC01LS) is the first listed.
NCT02599896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02599896 about?
NCT02599896 is a clinical study titled "Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults". Background: Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses. Researchers want to see if it does this in people. Objectives: To see if VRC01LS is safe and well-tole...
What is the current status of trial NCT02599896?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2015-11-16. Estimated completion is 2018-07-25.
What interventions are being tested in trial NCT02599896?
The interventions under investigation include: VRC-HIVMAB080-00-AB (VRC01LS) (BIOLOGICAL), VRC-HIVMAB060-00-AB (VRC01) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02599896?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02599896's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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