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NCT03478891 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
A Phase 1 study of Healthy Adult Immune Responses to Vaccine, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03478891: Completed Phase 1 study of Healthy Adult Immune Responses to Vaccine, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03478891 is a Phase 1 study of Healthy Adult Immune Responses to Vaccine that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478891, a Phase 1 study of Healthy Adult Immune Responses to Vaccine, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Ebola is a virus that has infected and killed people mostly in West Africa. There is no treatment or prevention for it, but several drugs are being studied. Researchers want to test the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for Ebola treatment in people who are infected in the future. This trial will not expose volunteers to the Ebola virus. Objectives: To see if MAb114 is safe and how a person's body responds to it. Eligibility: Healthy adults ages 18-60 who weigh 220.5 pounds or less Design: Participants will be screened under protocol NIH 11-I-0164 with: * Medical history * Physical exam * Blood or urine tests Participants will have a first 8- to10-hour visit. They will get MAb114 by IV infusion. For this, a thin tube will be placed in an arm vein. They may get an IV line in their other arm to collect blood. Blood will be taken many times before and after the infusion. Participants may have a urine test. Participants will get a thermometer to check their temperature for 3 days after they get MAb114. They will record their highest temperature and any symptoms. Participants will have about 14 more study visits over 6 months. At each visit, they will have blood taken and be checked for any health changes. They will talk about how they are feeling and if they have taken any medications. At the end of the 6 months, participants may be invited to take part in another study for follow-up sample collection.
Primary Outcome
Possible infusion reaction symptoms: unusually tired/feeling unwell, muscles aches, headache, chills, rigors, nausea, fever, joint pain, urticaria/rash, and pruritus. Also information was collected if administration was slowed down or stopped for reactogenicity reasons.
Conditions Studied
Interventions
- BIOLOGICAL VRC-EBOMAB092-00-AB (MAb114)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-05-16 |
| Est. Completion | 2019-03-20 |
| Phase | Phase 1 |
What the finished NCT03478891 record still lists
NCT03478891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Healthy Adult Immune Responses to Vaccine appearing as the primary indexed condition, and to 1 intervention - of which VRC-EBOMAB092-00-AB (MAb114) is the first listed.
NCT03478891 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03478891 about?
NCT03478891 is a clinical study titled "Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults". Background: Ebola is a virus that has infected and killed people mostly in West Africa. There is no treatment or prevention for it, but several drugs are being studied. Researchers want to test the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for Ebola treatment ...
What is the current status of trial NCT03478891?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-05-16. Estimated completion is 2019-03-20.
What conditions does trial NCT03478891 study?
This clinical trial studies the following conditions: Healthy Adult Immune Responses to Vaccine.
What interventions are being tested in trial NCT03478891?
The interventions under investigation include: VRC-EBOMAB092-00-AB (MAb114) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03478891?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03478891 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03478891's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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