Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.

Completed

• Conditions: Influenza

• Registration Number: NCT01262079
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. This protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the U.S. population early and late in the 2010-2011 influenza season. Immune responses will be evaluated using blood samples. The underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-17
• Primary Completion: 2011-07
• Status Verified: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Children ages 6 through 17 years and adults 18 years of age or older
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Able and willing to complete the informed consent/assent process
• Willing to donate blood for storage and for research, at least at three study visits
• Willing to have genetic tests performed on stored blood for research purposes

Exclusion Criteria

• Known to be pregnant.
• Medical, psychiatric, occupational or other condition that, in the judgment of the site investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
• Bleeding disorder diagnosis or any contraindications to blood drawing as assessed by the site investigator
• Immune system known to be compromised by HIV or other active infection, active cancer, or systemic immunosuppressive treatments.
• Seasonal influenza vaccine within the 12 weeks prior to enrollment.
• Another subject from the same household enrolled into the same age group.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influenza-specific antibody responses	2010-2011 influenza season	To evaluate antibody responses to a panel of influenza strains across a broad age range of the U.S. population early as compared to late in the 2010-2011 influenza season.

Secondary Outcome Measures

Name	Time	Method
Influenza-specific T-cell responses	2010-2011 influenza season	To evaluate influenza-specific T-cell responses to a panel of influenza strains across a broad age range of the U.S. population early as compared to late in the 2010-2011 influenza season.

Trial Locations

Locations (4)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Hope Clinic of the Emory Vaccine Center; 🇺🇸 Decatur, Georgia, United States

St. Louis University - Doisy Research Center; 🇺🇸 St. Louis, Missouri, United States

Cincinatti Children's Hospital Medical Center; 🇺🇸 Cincinatti, Ohio, United States