InfluenzaPhase 4NCT01987349

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

A Phase 4 study testing Fluzone® (intramuscular) and FluMist® (intranasal) in people with Influenza, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare influenza vaccine responses in monozygotic and dizygotic twins. 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® (intramuscular) and FluMist® (intranasal)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Jan 2010
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 or adults, ages 8-17 years (identical twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or 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 and vital signs.
Negative urine pregnancy test for women of childbearing potential
If the subject is female and of childbearing potential, she must use an acceptable method of contraception and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner).

Who cannot join

Prior vaccination with 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 (LAIV groups only)
Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
History of immune deficiency

Show all 24Show 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, blood pressure >150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
Hospitalization in the past year for congestive heart failure or emphysema.
Chronic Hepatitis B or C
Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
Subjects 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, Plavix, Aggrenox may be acceptable after review by investigator.
Receipt of blood or blood products within the past 6 months
Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
Inactivated vaccine 14 days prior to vaccination
Live, attenuated vaccine within 60 days of vaccination
History of Guillain-Barre 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 University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009

This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

Read the detailed description

The investigators plan to study the response to different influenza vaccines much more broadly and deeply across different age groups and with different vaccine modalities and to probe the influence of genetics on these responses using monozygotic and dizygotic twins.

Conditions: Influenza
Being tested: Fluzone® (intramuscular), FluMist® (intranasal)
Keywords: Influenza vaccines, healthy participants, immunity to influenza, identical twins, fraternal twins, non-twins
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® (intramuscular)Biological
Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
FluMist® (intranasal)Biological
Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)

Study groups in NCT01987349
Study group	Role	What they receive
Group A: age 8-17 yo identical twins	Other	Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal) Receives: Biological: Fluzone® (intramuscular); Biological: FluMist® (intranasal)
Group B: 18-30 yo identical twins	Other	Participants to receive FluMist® (intranasal) Receives: Biological: FluMist® (intranasal)
Group C: 18-30 yo fraternal twins	Other	Participants to receive FluMist® (intranasal) Receives: Biological: FluMist® (intranasal)
Group D: 40-49 yo identical twins	Other	Participants to receive FluMist® (intranasal) Receives: Biological: FluMist® (intranasal)
Group E: 40-49 yo fraternal twins	Other	Participants to receive FluMist® (intranasal) Receives: Biological: FluMist® (intranasal)
Group F: 70-100 yo twins	Other	Participants to receive Fluzone® (intramuscular) Receives: Biological: Fluzone® (intramuscular)
Group G: 70-100 yo non-twins	Other	Participants to receive Fluzone® (intramuscular) Receives: Biological: Fluzone® (intramuscular)

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 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.

Sep 2009Jan 2010

First posted19 Nov 2013 (estimated)
Study startSep 2009
Primary completionJan 2010
Study completionJan 2010

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 (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 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01987349
Sponsor's protocol ID: SU-17219-2009
Other IDs: 2U19AI057229-06
Status last verified: Apr 2017
First submitted: 24 Oct 2013
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Horowitz A, Strauss-Albee DM, Leipold M, Kubo J, Nemat-Gorgani N, Dogan OC, Dekker CL, Mackey S, Maecker H, Swan GE, Davis MM, Norman PJ, Guethlein LA, Desai M, Parham P, Blish CA. Genetic and environmental determinants of human NK cell diversity revealed by mass cytometry. Sci Transl Med. 2013 Oct 23;5(208):208ra145. doi: 10.1126/scitranslmed.3006702.
PubMed 24154599
Brodin 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 25594173
Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.
PubMed 29706550

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protective Mechanisms Against a Pandemic Respiratory Virus: B- Cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. Year 1, 2009
ClinicalTrials.gov ID: NCT01987349
Acronym / sponsor ID: SU-17219-2009
Conditions: Influenza
Keywords: Influenza vaccines, healthy participants, immunity to influenza, identical twins, fraternal twins, non-twins
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Sep 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 12 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will compare influenza vaccine responses in monozygotic and dizygotic twins.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Group A: age 8-17 yo identical twins	Other	Biological: Fluzone® (intramuscular), Biological: FluMist® (intranasal)Participants will be randomized to receive either Fluzone® (intramuscular) or FluMist® (intranasal)
Group B: 18-30 yo identical twins	Other	Biological: FluMist® (intranasal)Participants to receive FluMist® (intranasal)
Group C: 18-30 yo fraternal twins	Other	Biological: FluMist® (intranasal)Participants to receive FluMist® (intranasal)
Group D: 40-49 yo identical twins	Other	Biological: FluMist® (intranasal)Participants to receive FluMist® (intranasal)
Group E: 40-49 yo fraternal twins	Other	Biological: FluMist® (intranasal)Participants to receive FluMist® (intranasal)
Group F: 70-100 yo twins	Other	Biological: Fluzone® (intramuscular)Participants to receive Fluzone® (intramuscular)
Group G: 70-100 yo non-twins	Other	Biological: Fluzone® (intramuscular)Participants to receive Fluzone® (intramuscular)

Who may qualify

Ages: 8 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Otherwise healthy, ambulatory children or adults, ages 8-17 years (identical twin pairs), 18-30 years (identical or fraternal twin pairs), 40-49 years (identical or fraternal twin pairs) or 70-100 years (twin or 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 and vital signs.
Negative urine pregnancy test for women of childbearing potential

Key exclusion criteria (24 listed)

Prior vaccination with 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 (LAIV groups only)
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® (intramuscular)Licensed seasonal trivalent inactivated influenza vaccine (IIV3)	Biological	Group A: age 8-17 yo identical twins, Group F: 70-100 yo twins, Group G: 70-100 yo non-twins
FluMist® (intranasal)Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)	Biological	Group A: age 8-17 yo identical twins, Group B: 18-30 yo identical twins, Group C: 18-30 yo fraternal twins, Group D: 40-49 yo identical twins, Group E: 40-49 yo fraternal twins

Primary outcome

Number of Participants From Each Arm Who Received Influenza Vaccine 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

Results posted to the registry on 12 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Age 8-17 yo Identical Twins	6	6
Group A: Age 8-17yo Identical Twins	6	6
Group B: Age 18-30 yo Identical Twins	8	8
Group C: Age 18-30 yo Fraternal Twins	6	6
Group D: Age 40-49 yo Identical Twins	6	6
Group E: Age 40-49 yo Fraternal Twins	6	6
Group F: 70-100 yo Identical Twins	10	10
Group G: 70-100 yo Nontwins	25	24

Primary outcome: Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine

Time frame: Day 0 to 28. Count of participants. Unit: Participants

Measure	Group A: Age 8-17 yo Identical Twins (IM) n = 6	Group A: Age 8-17 yo Identical Twins (IN) n = 6	Group B: 18-30 yo Identical Twins n = 8	Group C: 18-30 yo Fraternal Twins n = 6	Group D: 40-49 yo Identical Twins n = 6	Group E: 40-49 yo Fraternal Twins n = 6	Group F: 70-100 yo Twins n = 10	Group G: 70-100 yo Non-twins n = 24
Value	6	6	8	6	6	6	10	24

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 0 to Day 28 of study participation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Age 8-17 yo Identical Twins (Fluzone)	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group A: Age 8-17 yo Identical Twins (Flumist)	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group B: 18-30 yo Identical Twin Pairs	0 of 8 (0%)	0 of 8 (0%)	Not reported
Group C: 18-30 yo Fraternal Twins	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group D: 40-49 yo Identical Twins	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group E: 40-49 yo Fraternal Twins	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group F: 70-100 yo Twins	0 of 10 (0%)	0 of 10 (0%)	Not reported
Group G: 70-100 yo Non-twins	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24154599Horowitz A, Strauss-Albee DM, Leipold M, Kubo J, Nemat-Gorgani N, Dogan OC, Dekker CL, Mackey S, Maecker H, Swan GE, Davis MM, Norman PJ, Guethlein LA, Desai M, Parham P, Blish CA. Genetic and environmental determinants of human NK cell diversity revealed by mass cytometry. Sci Transl Med. 2013 Oct 23;5(208):208ra145. doi: 10.1126/scitranslmed.3006702.
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 29706550Cheung P, Vallania F, Warsinske HC, Donato M, Schaffert S, Chang SE, Dvorak M, Dekker CL, Davis MM, Utz PJ, Khatri P, Kuo AJ. Single-Cell Chromatin Modification Profiling Reveals Increased Epigenetic Variations with Aging. Cell. 2018 May 31;173(6):1385-1397.e14. doi: 10.1016/j.cell.2018.03.079. Epub 2018 Apr 26.
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

Mark M Davis, PhD principal investigator

Stanford University

Garry Nolan, 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® (intramuscular) and FluMist® (intranasal) 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 6 inclusion and 24 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 12 May 2017. 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 12 May 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 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 NCT01987349, 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 12 May 2017.