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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Influenza-specific antibody responses

Time frame: 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 outcomes

Influenza-specific T-cell responses

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

The Emmes Company, LLC

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 17, 2010
Registry last updated: Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed