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.
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | The EMMES Corporation |
United States,
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
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 |
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