MedTrace Logo

Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers

NCT02484417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-10

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

RSV A2

Intranasal inoculation of healthy volunteers with 10\^5 or 10\^6.3 plaque forming units (PFU) of RSV A2.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jeffrey I Cohen, 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
No

Timeline & Regulatory

Start
2015-07-21
Primary Completion
2016-08-10
Completion
2016-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02484417 on ClinicalTrials.gov