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Influenza Surveillance

Family Surveillance

The Family Surveillance study will be conducted as a prospective, non-interventional surveillance study in consenting families. Families will consist of units of at least three individuals with household contact, at least one of who will be 4 years old or younger at the time of enrollment. All consenting subjects in the family will have peripheral venous blood obtained at two time points each year, the “Fall” blood draw, and the “Spring” blood draw. The “Fall” blood draw is designed to represent a post vaccination – pre-influenza season time point. The “Spring” blood draw is designed to represent a post influenza season – pre-vaccination time point. In addition, families will undergo surveillance during the influenza season during which they will record the presence or absence of influenza-like symptoms on a weekly basis. Subjects meeting the case definition will have nasal and throat swabs for influenza culture. Subjects with positive cultures for influenza will have a single additional blood draw approximately 2 to 4 weeks after confirmation of influenza illness to assess their response to infection.

The goal of this study is to perform a detailed evaluation of the cellular response to primary and secondary infection and immunization with influenza virus and influenza vaccines, including:

• Identify, in humans, specific T cell responses to influenza epitopes shared among serologically distinct viruses following primary and secondary infections.
• Identify H1, H3, and H5 hemagglutinin-specific human B cell responses by FACS and ELISPOT
• Compare and contrast potential heterosubtypic immune responses induced by influenza infection or vaccination in humans.
• Use novel cellular markers (such as VLA-1/CCR7/CD62L) to identify T cells in the peripheral blood with the potential to become extralymphoid memory T cells.

Student Surveillance

The Student Surveillance study will be conducted as a prospective, non-interventional surveillance study among consenting college students. All consenting subjects will have peripheral venous blood obtained at two time points each year, the “Fall” blood draw, and the “Spring” blood draw. The “Fall” blood draw will take place prior to administration of influenza vaccine to the subject, and the “Spring” blood draw will take place after the influenza season has ended. In addition, if subjects receive influenza vaccine, a post-vaccination blood draw will be obtained approximately one month after vaccination. Surveillance for influenza will be conducted during the influenza season, during which time subjects will record on the flu surveillance diary card or a password protected secured internet web site the presence or absence of influenza-like symptoms on a weekly basis. Subjects meeting the case definition for influenza will have an acute blood sample drawn and will have nasal and throat swabs for influenza culture. Subjects with positive tests for influenza will have a single additional blood draw approximately 2 to 4 weeks after onset of the influenza to assess the immune response to infection.

The goal of this protocol is to perform a detailed evaluation of the cellular response to primary and secondary infection and immunization with influenza virus and influenza vaccines, including:

• Identify, in humans, specific T cell responses to influenza epitopes shared among serologically distinct viruses following primary and secondary infections.
• Identify H1, H3, and H5 hemagglutinin-specific human B cell responses by FACS and ELISPOT
• Compare and contrast potential heterosubtypic immune responses induced by influenza infection or vaccination in humans.

Use novel cellular markers (such as VLA-1/CCR7/CD62L) to identify T cells in the peripheral blood with the potential to become extralymphoid memory T cells.

Acute Influenza in Adults, Children, and the Elderly

The Acute Influenza in Adults, Children, and the Elderly study will be conducted as a prospective surveillance study according to the schema outlined in the figure below:

The objectives of this protocol are:

• Acquisition of samples for the analysis of adaptive immune responses in the peripheral blood of individuals infected with influenza virus.
• Identification of cross-reactive T and B cell responses to the emerging influenza viruses
• Characterization of protective and/or potentially pathogenic T cell differentiation associated with seasonal or novel influenza virus infection.
• Characterization of the levels and duration of viral shedding in infected individuals and correlation of viral shedding with the severity of influenza symptoms.
• Determination of the frequency of asymptomatic infection of household contacts
• Characterization of phenotypic and genotypic changes in viruses during the course of the pandemic, determination whether evolution and adaptation are taking place.
• Development of kinetic data related to viral replication and humoral and cellular immune responses to infection that could be used in computer models of the human immune response to influenza