Challenge Infection of Healthy Adult Volunteers With RSV A2

Completed · Phase 1

Conditions studied: Upper Respiratory Tract Infections

In brief

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.

Key facts

Study ID

NCT03388645

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

19

Starts

2018-02-20

Expected to finish

2019-12-06

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subject who was previously challenged with RSV A2.
• Female subject who is pregnant or lactating OR planning to become pregnant from 30 days prior to inoculation through 30 days after inoculation.
• Presence of self-reported or medically documented significant medical condition(s) including but not limited to:
• Respiratory disease (e.g., chronic obstructive pulmonary disease, emphysema, rhinitis, sinusitis) in adulthood, and additionally:
• -A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with
• exercise, seasonal hay fever or allergic rhinitis
• -Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
• Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis within 90 days prior to viral inoculation or nasal or sinus surgery within 180 days prior to viral inoculation.
• Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease).
• Chronic neurological or neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Ongoing malignancy.
• Chronic medical condition requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathy, autoimmune disease).
• An immunodeficiency.
• Use of systemic corticosteroids exceeding 10 mg/day of prednisone equivalent and nasal steroid preparations or immunosuppressive drugs within 30 days before inoculation and within 60 days after. Low dose topical steroid preparations used for a discrete period of time are permitted.
• Inhaled bronchodilator or inhaled steroid use within the last 360 days or use after upper respiratory tract infections.
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• Complete blood count (CBC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine values or other screening labs or tests (e.g. electrocardiogram (EKG), chest x-ray (CXR)) are outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
• Positive FDA-approved HIV test obtained during screening procedures.
• Positive serology for hepatitis C virus obtained during screening period.
• Presence of hepatitis B surface antigen obtained during screening period.
• A smoker of tobacco products or a routine marijuana smoker currently or in the past year.
• Current alcohol abuse or addiction.
• Current illicit drug abuse or addiction.
• Receipt of a licensed vaccine within 30 days prior to RSV A2 inoculation and planned vaccination within 60 days after inoculation..
• Receipt of blood or blood-derived products (including immunoglobulin) within 180 days prior to viral inoculation. Receipt of packed red blood cells given for an emergent indication in an otherwise healthy person, and not required as ongoing treatment, is not exclusionary.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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