Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
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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. |
- 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.
- 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 |
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.
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| 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 | |
| Study Director: | Barney S. Graham, M.D., Ph.D. | Chief: Clinical Trials Core |
More Information
Additional Information:
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 |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013