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NCT03388645 · ClinicalTrials.gov registry record · Phase 1
Challenge Infection of Healthy Adult Volunteers With RSV A2
A Phase 1 study of Upper Respiratory Tract Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03388645: Completed Phase 1 study of Upper Respiratory Tract Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03388645 is a Phase 1 study of Upper Respiratory Tract Infections 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
NCT03388645, a Phase 1 study of Upper Respiratory Tract Infections, 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: One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Researchers want to study RSV infection in a safe, controlled setting in healthy adults to help develop new treatments. Objective: To test the safety of a high dose of RSV A2 by spraying the virus into the nose, and studying how the body responds. Eligibility: Healthy adults ages 18-50 Design: Participants will be screened during 2 screening visits with: * Medical interview * Physical exam * Blood and nasal samples * Chest X-ray (chest radiograph) * Participants will have a heart test. Sticky patches on the body will detect heart electrical activity. * Pulmonary function test (PFT). They will blow into a machine to measure airflow. * Urine tests for pregnancy or drug use. Participants will be admitted to the hospital before they get RSV A2. Participants will get a single dose of RSV A2 as two sprays, one into each nostril. Participants will stay in the hospital under isolation for as long as it takes the body to clear RSV A2 from nasal fluids. This can take as long as 14 days or more. Participants cannot take any cold medicine to try to feel better. Every day, participants will: * Answer questions about their symptoms * Have nasal washes and/or nasal swabs collected * Have a physical exam Participants will have blood drawn most days. After discharge, participants will keep a health diary. Participants will have 2 follow-up visits at 1 month and 2 months after receiving the RSV A2 dose. A history and physical examination, a blood draw, and nasal wash and swab will be performed.
Primary Outcome
Participants who had shedding of RSV as assessed by detection of RSV A2 in nasal wash by FilmArray multiplex polymerase chain reaction (PCR), by reverse transcriptase (RT)-quantitative PCR, or by quantitative viral culture.
Conditions Studied
Interventions
- BIOLOGICAL 10^6.3 PFU of RSV A2
- BIOLOGICAL 10^7 PFU of RSV A2
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2019-12-06 |
| Phase | Phase 1 |
What the finished NCT03388645 record still lists
NCT03388645 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 Upper Respiratory Tract Infections appearing as the primary indexed condition, and to 2 interventions - of which 10^6.3 PFU of RSV A2 is the first listed.
NCT03388645 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03388645 about?
NCT03388645 is a clinical study titled "Challenge Infection of Healthy Adult Volunteers With RSV A2". Background: One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. R...
What is the current status of trial NCT03388645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-02-20. Estimated completion is 2019-12-06.
What conditions does trial NCT03388645 study?
This clinical trial studies the following conditions: Upper Respiratory Tract Infections.
What interventions are being tested in trial NCT03388645?
The interventions under investigation include: 10^6.3 PFU of RSV A2 (BIOLOGICAL), 10^7 PFU of RSV A2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03388645?
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 NCT03388645 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03388645'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
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