Challenge Infection of Healthy Adult Volunteers With RSV A2
Public ClinicalTrials.gov record NCT03388645. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03388645
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2018
- Primary completion
- Nov 14, 2019
- Completion
- Dec 5, 2019
- Last update posted
- Dec 2, 2020
2018 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03388645, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2020 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03388645 live on ClinicalTrials.gov.