Clinical trial NCT01262079: Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
Official title: Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: influenza
healthy volunteer
immunity
antibody
blood sample
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: The Emmes Company, LLC
First posted: 2010-12-17
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Influenza-specific antibody responses
timeFrame: 2010-2011 influenza season
Secondary outcomes:
measure: Influenza-specific T-cell responses
timeFrame: 2010-2011 influenza season
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Hope Clinic of the Emory Vaccine Center
state: Georgia
city: St. Louis
country: United States
facility: St. Louis University - Doisy Research Center
state: Missouri
city: Cincinatti
country: United States
facility: Cincinatti Children's Hospital Medical Center
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Chief: Clinical Trials Core
name: Barney S. Graham, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.