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

NCT01262079 | Completed

• 2 other identifiers: VRC 700HHSN272201000049I
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Influenza

Keywords

influenza; healthy volunteer; immunity; antibody; blood sample

Outcome Measures

Primary Outcomes (1)

• Influenza-specific antibody responses

  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.

  2010-2011 influenza season

Secondary Outcomes (1)

• Influenza-specific T-cell responses

  2010-2011 influenza season

Study Arms (9)

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 Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• The Emmes Company, LLC: collaborator

Study Sites (4)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

St. Louis University - Doisy Research Center

St Louis, Missouri, 63104, United States

Location

Cincinatti Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 16413916 BACKGROUND

• 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.

  PMID: 20647428 BACKGROUND

• 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.

  PMID: 19478718 BACKGROUND

Related Links

• NIAID

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma PBMC Whole-blood

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Barney S. Graham, M.D., Ph.D.

  Chief: Clinical Trials Core

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 15, 2011

Record last verified: 2011-08

Locations

US (4)