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NCT03557008 · ClinicalTrials.gov registry record · Phase 4
Responses to Rabies Vaccine in Adults With or Without Antibiotics
A Phase 4 study of Rabies Human, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT03557008: Completed Phase 4 study of Rabies Human, sponsored by Emory University.
NCT03557008 is a Phase 4 study of Rabies Human that has completed, run by Emory University. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557008, a Phase 4 study of Rabies Human, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
The use of antibiotics changes micro-organisms in the intestines which may impact the body's vaccine immune response and alter the effectiveness of the rabies vaccine. There will be two randomized groups (1:1 randomization). Group A will start taking an antibiotic regimen by mouth 3 days prior to vaccination and continue taking antibiotics the day of rabies vaccination and one day after vaccination for a total of 5 days. Group B will only receive the rabies vaccination and will not take any antibiotics. The dosage of each antibiotic is taken from their respective package inserts and does not exceed the maximum dose allowed for each antibiotic. The purpose of the study is to look at immune response after rabies vaccination with or without the use of antibiotics from day of vaccination to 28 days post vaccination in both groups.
Primary Outcome
Antibody titers are examined by direct comparison of antibody titers in the blood. Rabies specific Immunoglobulin G (IgG) endpoint titer was measured by ELISA. The endpoint titer is defined as the reciprocal of the highest plasma dilution that gives a reading above the cutoff values. The cutoff is set based on the average plus 3 times the standard deviation of the reading of 1:160 dilution of baseline plasma.
Conditions Studied
Interventions
- DRUG Vancomycin
- DRUG Metronidazole
- BIOLOGICAL Rabies Vaccine
- DRUG Neomycin Sulfate
Study Locations (2)
Georgia
- Winship Cancer Institute of Emory University - Atlanta
- The Hope Clinic of the Emory Vaccine Center - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2022-06-02 |
| Phase | Phase 4 |
What the finished NCT03557008 record still lists
NCT03557008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Rabies Human appearing as the primary indexed condition, and to 4 interventions - of which Vancomycin is the first listed.
NCT03557008 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03557008 about?
NCT03557008 is a clinical study titled "Responses to Rabies Vaccine in Adults With or Without Antibiotics". The use of antibiotics changes micro-organisms in the intestines which may impact the body's vaccine immune response and alter the effectiveness of the rabies vaccine. There will be two randomized groups (1:1 randomization). Group A will start taking an antibiotic regimen by mouth 3 days prior to v...
What is the current status of trial NCT03557008?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2018-07-05. Estimated completion is 2022-06-02.
What conditions does trial NCT03557008 study?
This clinical trial studies the following conditions: Rabies Human.
What interventions are being tested in trial NCT03557008?
The interventions under investigation include: Vancomycin (DRUG), Metronidazole (DRUG), Rabies Vaccine (BIOLOGICAL), Neomycin Sulfate (DRUG).
Who is sponsoring clinical trial NCT03557008?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03557008 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03557008's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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