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NCT03565315 · ClinicalTrials.gov registry record · Phase 1
Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03565315: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03565315 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565315, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made artificially in a lab can help to prevent HIV infection. The antibodies are 10E8VLS and VRC07-523LS. Objective: To see if 10E8VLS and VRC07-523LS are safe and well-tolerated and how long they stay in the blood. Eligibility: Healthy adults ages 18-60 Design: Volunteers were screened in another protocol. Participants were enrolled in 1 of 4 groups: Group 1 participants were enrolled to receive 1 dose of 10E8VLS. Group 2 participants were enrolled to receive 3 doses of 10E8VLS. Group 3 participants were enrolled to receive 1 dose of both 10E8VLS and VRC07-523LS. Group 4 participants were enrolled to receive 3 doses of both 10E8VLS and VRC07-523LS. Participants in Groups 1 and 3 were expected to be enrolled about 13 visits over 24 weeks. Participants in Groups 2 and 4 were expected to be enrolled about 26 visits over 48 weeks. Participants were weighed before each dose. Women may have had a pregnancy test. Participants had blood collected. A small needle injected each dose into fatty tissue of the belly, upper arm, or thigh. Participants received between 1 and 8 injections per dose depending on their weight. Heavier participants received more injections. Participants received a ruler and thermometer. They checked their temperature for 3 days after injection(s) and measured any redness, swelling, or bruising at the injection site. At non-injection visits, participants had blood drawn and were checked for health changes or problems.
Primary Outcome
Local symptoms were recorded by participants using a 3-day diary. Solicited local symptoms include pain/tenderness, bruising, redness, swelling, and pruritus (itchiness) at the product administration site. Clinicians reviewed the diary with the participant and collected resolution information for any symptoms that were not resolved within 3 days. Participants were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. The
Interventions
- BIOLOGICAL VRC-HIVMAB095-00-AB (10E8VLS)
- BIOLOGICAL VRC-HIVMAB075-00-AB (VRC07-523LS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 1 |
Why NCT03565315 stopped before completion
NCT03565315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which VRC-HIVMAB095-00-AB (10E8VLS) is the first listed.
NCT03565315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03565315 about?
NCT03565315 is a clinical study titled "Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults". Background: Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made ar...
What is the current status of trial NCT03565315?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-07-10. Estimated completion is 2019-03-04.
What interventions are being tested in trial NCT03565315?
The interventions under investigation include: VRC-HIVMAB095-00-AB (10E8VLS) (BIOLOGICAL), VRC-HIVMAB075-00-AB (VRC07-523LS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03565315?
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 NCT03565315's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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