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

NCT ID: NCT01262079

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: 6-15 years old

No interventions assigned to this group

Group 2: 16-25 years old

No interventions assigned to this group

Group 3: 26-35 years old

No interventions assigned to this group

Group 4: 36-45 years old

No interventions assigned to this group

Group 5: 46-55 years old

No interventions assigned to this group

Group 6: 56-65 years old

No interventions assigned to this group

Group 7: 66-75 years old

No interventions assigned to this group

Group 8: 76-85 years old

No interventions assigned to this group

Group 9: > 85 years old

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Emmes Company, LLC

INDUSTRY

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Vaccine Research Center, NIAID, NIH

Principal Investigators

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Barney S. Graham, M.D., Ph.D.

Role: STUDY_DIRECTOR

Chief: Clinical Trials Core

Locations

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Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, United States

Site Status

St. Louis University - Doisy Research Center

St Louis, Missouri, United States

Site Status

Cincinatti Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16413916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20647428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19478718 (View on PubMed)

Related Links

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Other Identifiers

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HHSN272201000049I

Identifier Type: OTHER

Identifier Source: secondary_id

VRC 700

Identifier Type: -

Identifier Source: org_study_id

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