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

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

Influenza

Study type

Observational

Funder types

Industry
NIH

Identifiers

NCT01262079
HHSN272201000049I (Other Identifier)
VRC 700

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

6+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

180 participants in 9 patient groups

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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