InfluenzaNCT01262079
Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinatti Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
Baylor College of Medicine
Houston, Texas, 77030
St. Louis University - Doisy Research Center
St Louis, Missouri, 63104
About this study
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
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 6-15 years old | Not described | |
| Group 2: 16-25 years old | Not described | |
| Group 3: 26-35 years old | Not described | |
| Group 4: 36-45 years old | Not described | |
| Group 5: 46-55 years old | Not described | |
| Group 6: 56-65 years old | Not described | |
| Group 7: 66-75 years old | Not described | |
| Group 8: 76-85 years old | Not described | |
| Group 9: > 85 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2010-2011 influenza season
Secondary outcomes (1)
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.
Measured: 2010-2011 influenza season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Investigators
- Barney S. Graham, M.D., Ph.D., Study director, Chief: Clinical Trials Core
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262079
- Sponsor's protocol ID
- VRC 700
- Other IDs
- HHSN272201000049I
- Status last verified
- Aug 2011
- First submitted
- 15 Dec 2010
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16413916Wei 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.
PubMed 20647428Centers 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.
PubMed 19478718
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.
- ClinicalTrials.gov ID
- NCT01262079
- Acronym / sponsor ID
- VRC 700
- Conditions
- Influenza
- Keywords
- influenza, healthy volunteer, immunity, antibody, blood sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influenza-specific antibody responses
Time frame: 2010-2011 influenza season
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.
1 secondary outcome
Influenza-specific T-cell responses
Time frame: 2010-2011 influenza season
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
- Background: PubMed 16413916Subbarao 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.
- Background: PubMed 20647428Wei 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.
- Background: PubMed 19478718Centers 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.
- NIAIDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barney S. Graham, M.D., Ph.D. study director
Chief: Clinical Trials Core
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza-specific antibody responses (time frame: 2010-2011 influenza season). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.