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Challenge Infection of Healthy Adult Volunteers With RSV A2

NCT03388645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-12-03

Study results available
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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.

Conditions

  • Upper Respiratory Tract Infections

Interventions

BIOLOGICAL

10^6.3 PFU of RSV A2

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.

BIOLOGICAL

10^7 PFU of RSV A2

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lesia K Dropulic, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-20
Primary Completion
2019-11-15
Completion
2019-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388645 on ClinicalTrials.gov