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

This study has been completed.
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01262079
First received: December 15, 2010
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Influenza-specific antibody responses [ Time Frame: 2010-2011 influenza season ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Influenza-specific T-cell responses [ Time Frame: 2010-2011 influenza season ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Serum Plasma PBMC Whole-blood


Estimated Enrollment: 180
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262079

Locations
United States, Georgia
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
United States, Missouri
St. Louis University - Doisy Research Center
St. Louis, Missouri, United States, 63104
United States, Ohio
Cincinatti Children's Hospital Medical Center
Cincinatti, Ohio, United States, 45229
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
The EMMES Corporation
Investigators
Study Director: Barney S. Graham, M.D., Ph.D. Chief: Clinical Trials Core
  More Information

Additional Information:
NIAID  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Vaccine Research Center, NIAID, NIH contact: Chief, Clinical Trials Core, Vaccine Research Center, NIAID, NIH
ClinicalTrials.gov Identifier: NCT01262079     History of Changes
Other Study ID Numbers: VRC 700, HHSN272201000049I
Study First Received: December 15, 2010
Last Updated: August 11, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
influenza
healthy volunteer
immunity
antibody
blood sample

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014