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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262079
• Other study ID #: VRC 700
• Secondary ID: HHSN272201000049
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: August 11, 2011
• Start date: December 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United States	Cincinatti Children's Hospital Medical Center	Cincinatti	Ohio
United States	Hope Clinic of the Emory Vaccine Center	Decatur	Georgia
United States	Baylor College of Medicine	Houston	Texas
United States	St. Louis University - Doisy Research Center	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	The EMMES Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Influenza-specific T-cell responses	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.	2010-2011 influenza season	No

External Links

•   NIAID