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

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.

Study Overview

• Status: Completed
• Conditions: Influenza

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Hope Clinic of The Emory Vaccine Center
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • St. Louis University - Doisy Research Center
  • Ohio
    • Cincinatti, Ohio, United States, 45229
      • Cincinatti Children's Hospital Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy participants ages 6 years and older who are available for 3 clinic study visits over approximately eight months. Participants must be willing and able to donate blood for storage and research. Females must not be or become pregnant during the study. Multiple subjects from the same household may not be enrolled into the same age group.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
Group 1: 6-15 years old
Group 2: 16-25 years old
Group 3: 26-35 years old
Group 4: 36-45 years old
Group 5: 46-55 years old
Group 6: 56-65 years old
Group 7: 66-75 years old
Group 8: 76-85 years old
Group 9: > 85 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza-specific antibody responses	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.	2010-2011 influenza season

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influenza-specific T-cell responses	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.	2010-2011 influenza season

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: The Emmes Company, LLC
• Investigators: Study Director: Barney S. Graham, M.D., Ph.D., Chief: Clinical Trials Core

Publications and helpful links

General Publications

• Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.
• Wei CJ, Boyington JC, McTamney PM, Kong WP, Pearce MB, Xu L, Andersen H, Rao S, Tumpey TM, Yang ZY, Nabel GJ. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science. 2010 Aug 27;329(5995):1060-4. doi: 10.1126/science.1192517. Epub 2010 Jul 15.
• Centers for Disease Control and Prevention (CDC). Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR Morb Mortal Wkly Rep. 2009 May 22;58(19):521-4.

Helpful Links

• NIAID

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): August 15, 2011
• Last Update Submitted That Met QC Criteria: August 11, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: influenza; healthy volunteer; antibody; immunity; blood sample
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VRC 700; HHSN272201000049I (Other Identifier: Department of Health and Human Services)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No