Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children

NCT00593918 | Completed Results DMC

• 1 other identifier: 7K08HL071742-05
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

In this project we will study the capacity for single nucleotide polymorphisms (SNP) in TLR4 gene to induce varying levels of inflammatory chemokine and cytokine production.

Conditions

Respiratory Syncytial Virus Infection

Keywords

RSV, asthma, innate immunity, gene, cytokines

Outcome Measures

Primary Outcomes (2)

• Nasal Interferon (IFN)-a2

  Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.

  1-5 days during acute illness (not after day 5 of illness)

• Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression

  IL-2 measured from nasal lavage samples by Luminex multiplex assay

  1-5 days during acute illness (not after day 5 of illness)

Study Arms (2)

Toll-like Receptor 4 -2026/GG Genotype

Toll-like Receptor 4 (TLR4) -2026/GG Genotype of interest hypothesized to be associated with less inflammation during Respiratory Syncytial virus (RSV) infection

Toll-like Receptor 4 -2026/AG and AA Genotypes

Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during respiratory syncytial virus (RSV) infection

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children who present with viral upper respiratory infections or bronchiolitis to their primary care physician. Upon consent, children willl have cheek samples for genotyping and nasal secretion samples to determine RSV infection.

You may qualify if:

• Parental or sibling history of asthma.
• Child must be less than 24 months of age.
• Presence of viral upper or lower respiratory tract symptoms.

You may not qualify if:

• History of recurrent wheezing requiring systemic corticosteroids.
• Prior history of lung disease.
• Birth \< 36 weeks gestation.
• Immunodeficiency
• Treatment with ribavirin, systemic or inhaled corticosteroids during the RSV infection.
• Congenital heart disease.
• No history of parental or sibling asthma.
• Less than 48 hour or more than 5 day duration of viral URI symptoms since the peak symptoms from RSV would be expected to occur from 2-5 days into course of infection.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792-9988, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal samples Supernatant from Peripheral mononuclear cell stimulation cultures DNA

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Asthma

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Subject withdraw before blood draw on second visit and small numbers recruited lead to small numbers of subjects analyzed.

Results Point of Contact

• Title: Theresa Guilbert, MD
• Organization: University of Wisconsin-Madison

tguilbert@wisc.edu

608-263-9608

Study Officials

• Theresa W. Guilbert, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: November 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 20, 2015
• Results First Posted: May 13, 2010

Record last verified: 2015-09

Locations

US (1)