InfluenzaPhase 4NCT02133781
B-cell Immunity to Influenza (SLVP017)- Year 1, 2009
A Phase 4 study testing Fluzone® 2009-2010 Formula and FluMist® 2009-2010 Formula in people with Influenza, run by Stanford University at 1 site in United States.
Trial summary
This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults. Read more about this study
- Who is it for?
- Ages 8 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluzone® 2009-2010 Formula and FluMist® 2009-2010 Formula
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old (non-twin) or 70-100 year-old elderly non-twin adults.
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- Acceptable medical history by medical history and vital signs.
Who cannot join
- Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009
- Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (for volunteers randomized to LAIV)
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
Show all 25Show fewer
- Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Blood pressure >150 systolic or >95 diastolic at first study visit
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible except for non-LAIV Group only). Use of oral steroids (<20 mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
- Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Receipt of blood or blood products within the past 6 months
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination
- Live, attenuated vaccine within 60 days of vaccination
- History of Guillain-Barré Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford LPCH Vaccine Program
Stanford, California, 94305
About this study
Official title: U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 1, 2009
This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.
Read the detailed description
This study is being conducted in healthy male and female volunteers. 8-17 year-old identical twins will be randomly assigned to receive a single administration of the 2009-2010 formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines. 18-30 year-old and 70-100 year-old subjects will receive a single administration of the 2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization.
- Conditions
- Influenza
- Being tested
- Fluzone® 2009-2010 Formula, FluMist® 2009-2010 Formula
- Keywords
- Inactivated influenza vaccine, Live, attenuated influenza vaccine, Child identical twins, Young and elderly adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® 2009-2010 FormulaBiological
Also called Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine
This vaccine is given intramuscularly
FluMist® 2009-2010 FormulaBiological
Also called Live, attenuated influenza vaccine (LAIV), FDA-licensed seasonal influenza vaccine
This vaccine is given intranasally
| Study group | Role | What they receive |
|---|---|---|
| Age 8-17 years (identical twins ) | Experimental | Participants will be randomized to receive either Fluzone® 2009-2010 Formula or FluMist® 2009-2010 Formula Receives: Biological: Fluzone® 2009-2010 Formula; Biological: FluMist® 2009-2010 Formula |
| Age 18-30 years (non-twins) | Experimental | Participants will be receive Fluzone® 2009-2010 Formula Receives: Biological: Fluzone® 2009-2010 Formula |
| Age >70 years (non-twins) | Experimental | Participants will receive Fluzone® 2009-2010 Formula Receives: Biological: Fluzone® 2009-2010 Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants From Each Arm Who Received Influenza Vaccine
Measured: Day 0 to 28
Secondary outcomes (1)
Number of Participants With Related Adverse Events
Measured: Day 0 to 28 post-immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelia L. Dekker, Stanford University
- Investigators
- Cornelia L Dekker, MD, Principal investigator, Stanford UniversityHarry B Greenberg, MD, Principal investigator, Stanford UniversityXiaosong He, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133781
- Sponsor's protocol ID
- SU-17218- 2009
- Other IDs
- 2U19AI057229-06
- Status last verified
- May 2018
- First submitted
- 6 May 2014
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
He XS, Sasaki S, Narvaez CF, Zhang C, Liu H, Woo JC, Kemble GW, Dekker CL, Davis MM, Greenberg HB. Plasmablast-derived polyclonal antibody response after influenza vaccination. J Immunol Methods. 2011 Feb 28;365(1-2):67-75. doi: 10.1016/j.jim.2010.12.008. Epub 2010 Dec 21.
PubMed 21182843Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25.
PubMed 21785218He XS, Sasaki S, Baer J, Khurana S, Golding H, Treanor JJ, Topham DJ, Sangster MY, Jin H, Dekker CL, Subbarao K, Greenberg HB. Heterovariant cross-reactive B-cell responses induced by the 2009 pandemic influenza virus A subtype H1N1 vaccine. J Infect Dis. 2013 Jan 15;207(2):288-96. doi: 10.1093/infdis/jis664. Epub 2012 Oct 29.
PubMed 23107783Jiang N, He J, Weinstein JA, Penland L, Sasaki S, He XS, Dekker CL, Zheng NY, Huang M, Sullivan M, Wilson PC, Greenberg HB, Davis MM, Fisher DS, Quake SR. Lineage structure of the human antibody repertoire in response to influenza vaccination. Sci Transl Med. 2013 Feb 6;5(171):171ra19. doi: 10.1126/scitranslmed.3004794.
PubMed 23390249Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
PubMed 25594173de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.
PubMed 28963118
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire- Year 1, 2009
- ClinicalTrials.gov ID
- NCT02133781
- Acronym / sponsor ID
- SU-17218- 2009
- Conditions
- Influenza
- Keywords
- Inactivated influenza vaccine, Live, attenuated influenza vaccine, Child identical twins, Young and elderly adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.
Detailed description
This study is being conducted in healthy male and female volunteers. 8-17 year-old identical twins will be randomly assigned to receive a single administration of the 2009-2010 formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines. 18-30 year-old and 70-100 year-old subjects will receive a single administration of the 2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age 8-17 years (identical twins ) | Experimental | Biological: Fluzone® 2009-2010 Formula, Biological: FluMist® 2009-2010 FormulaParticipants will be randomized to receive either Fluzone® 2009-2010 Formula or FluMist® 2009-2010 Formula |
| Age 18-30 years (non-twins) | Experimental | Biological: Fluzone® 2009-2010 FormulaParticipants will be receive Fluzone® 2009-2010 Formula |
| Age >70 years (non-twins) | Experimental | Biological: Fluzone® 2009-2010 FormulaParticipants will receive Fluzone® 2009-2010 Formula |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old (non-twin) or 70-100 year-old elderly non-twin adults.
- Willing to complete the informed consent process.
- Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- Acceptable medical history by medical history and vital signs.
Key exclusion criteria (25 listed)
- Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009
- Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
- Life-threatening reactions to previous influenza vaccinations
- Asthma or history of wheezing (for volunteers randomized to LAIV)
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone® 2009-2010 FormulaAlso: Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccineThis vaccine is given intramuscularly | Biological | Age 18-30 years (non-twins), Age 8-17 years (identical twins ), Age >70 years (non-twins) |
| FluMist® 2009-2010 FormulaAlso: Live, attenuated influenza vaccine (LAIV), FDA-licensed seasonal influenza vaccineThis vaccine is given intranasally | Biological | Age 8-17 years (identical twins ) |
Primary outcome
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to 28
1 secondary outcome
Number of Participants With Related Adverse Events
Time frame: Day 0 to 28 post-immunization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21182843He XS, Sasaki S, Narvaez CF, Zhang C, Liu H, Woo JC, Kemble GW, Dekker CL, Davis MM, Greenberg HB. Plasmablast-derived polyclonal antibody response after influenza vaccination. J Immunol Methods. 2011 Feb 28;365(1-2):67-75. doi: 10.1016/j.jim.2010.12.008. Epub 2010 Dec 21.
- Background: PubMed 21785218Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25.
- Background: PubMed 23107783He XS, Sasaki S, Baer J, Khurana S, Golding H, Treanor JJ, Topham DJ, Sangster MY, Jin H, Dekker CL, Subbarao K, Greenberg HB. Heterovariant cross-reactive B-cell responses induced by the 2009 pandemic influenza virus A subtype H1N1 vaccine. J Infect Dis. 2013 Jan 15;207(2):288-96. doi: 10.1093/infdis/jis664. Epub 2012 Oct 29.
- Background: PubMed 23390249Jiang N, He J, Weinstein JA, Penland L, Sasaki S, He XS, Dekker CL, Zheng NY, Huang M, Sullivan M, Wilson PC, Greenberg HB, Davis MM, Fisher DS, Quake SR. Lineage structure of the human antibody repertoire in response to influenza vaccination. Sci Transl Med. 2013 Feb 6;5(171):171ra19. doi: 10.1126/scitranslmed.3004794.
- Background: PubMed 25594173Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
- Derived from this study: PubMed 28963118de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.
- Individual participant dataSharing planned: No
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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.
Cornelia L Dekker, MD principal investigator
Stanford University
Harry B Greenberg, MD principal investigator
Stanford University
Xiaosong He, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone® 2009-2010 Formula and FluMist® 2009-2010 Formula in people with Influenza, run by Stanford University at 1 site 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 4 inclusion and 25 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants From Each Arm Who Received Influenza Vaccine (time frame: Day 0 to 28). 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 NCT02133781, which also lists 6 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 6 Jun 2018.