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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety
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 |
What the finished NCT02484417 record still lists
NCT02484417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which RSV A2 is the first listed.
NCT02484417 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02484417's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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