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NCT02484417 · ClinicalTrials.gov registry record · Phase 1
Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02484417 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants.
The verdict
NCT02484417, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Background: \- Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. They want to use what they learn to test new treatments or vaccines in the future. Objectives: \- To study how the body responds to RSV. Eligibility: \- Healthy volunteers ages 18-50 Design: * Participants will be screened under another protocol. * Participants will have: * Medical history * Physical exams * EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs. * Chest x-ray * Pulmonary function tests. This measures how much air a person can move into and out of the lungs. * Blood and urine tests * Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab. * Participants will have two, possibly three, follow-up outpatient visits, approximately 1, 2 and 6 months after receiving the dose of RSV. * Participants will stay in the hospital under isolation for 7 or more days after getting the virus. * The average stay is 10 days. Participants cannot leave the isolation unit. They cannot have visitors. * The virus should cause a mild to medium cold. * Participants will fill out a symptom card every day in the hospital and for 1 month after. * Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital. * Female participants who are sexually active must remain abstinent or use an effective form of birth control for 1 month before and after getting the virus.
Interventions
- BIOLOGICAL RSV A2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2016-08-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02484417
The ClinicalTrials.gov registry entry for NCT02484417 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RSV A2 is the first listed.
NCT02484417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02484417 about?
NCT02484417 is a clinical study titled "Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers". Background: \- Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. They want to use...
What is the current status of trial NCT02484417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-07-21. Estimated completion is 2016-08-10.
What interventions are being tested in trial NCT02484417?
The interventions under investigation include: RSV A2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02484417?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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