CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
10^6.3 PFU of RSV A2 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03388645
NCT03388645Phase 1Completed

Challenge Infection of Healthy Adult Volunteers With RSV A2

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 3, 2018·Updated Dec 3, 2020

In Brief

A Phase 1 clinical trial evaluating 10^6.3 PFU of RSV A2 and 10^7 PFU of RSV A2 for Upper Respiratory Tract Infections. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 3, 2018
Enrollment StartFeb 20, 2018
Primary CompletionNov 15, 2019
Study CompletionDec 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.5 years ago

Interventions

10^6.3 PFU of RSV A2biological

Each adult volunteer will receive a single intranasal inoculation of 10\^6.3 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.

10^7 PFU of RSV A2biological

Each adult volunteer will receive a single intranasal inoculation of 10\^7 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.