InfluenzaPhase 1SLVP030NCT03453801
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
A Phase 1 study testing Fluzone® and FluMist® in people with Influenza and Healthy, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- What is being tested?
- Fluzone® and FluMist®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2014to 14 Jan 2019
- Phase
- Phase 1
- 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 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Otherwise healthy non-twins 6 months - 10 years old, or 2-5 year old identical (MZ) twins.
- Willing to complete the informed consent process (including assent for minors 7 years old and above).
- Availability for follow-up for the planned duration of the study - annually until 2018-2019 influenza vaccination season
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
- Non-twin flu/MMRV naive group: Willing to have primary care physician immunize child with the MMRV vaccine and return for a study visit approximately 60 days later.
Who cannot join
- Prior off-study vaccination with the current year's seasonal influenza vaccine.
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products, or to vaccine components
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- 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.
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- 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)
- Malignancy
- 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
- Receipt of blood or blood products within the past 6 months or planned used during the study.
- Receipt of Inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit ( ~ 28 Day after study vaccination)
- Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 Day after study vaccination)
- Need for allergy immunization (that cannot be postponed) during the study period.
- History of Guillain-Barré syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned donation prior to completion of the last visit.
- 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.
About this study
Official title: The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.
Read the detailed description
This is a Phase I study of up to 100 healthy children, ages 6 months to 10 years of age, who will receive either Flumist® live, attenuated influenza virus vaccine, quadrivalent (LAIV4) or the current Fluzone® inactivated influenza vaccine, quadrivalent (IIV4). The volunteers will be enrolled into one of 3 Groups. Volunteers will return each year until 2018-2019 for annual flu immunizations and study visits. Questionnaires will be administered annually to record demographic characteristics, vaccination history, exposure to animals, day care and medically attended illness. There are no exclusions for gender, ethnicity or race.
Volunteers in the Non-twin Flu/MMRV naive group will also receive the measles, mumps, rubella and varicella (MMRV) vaccine at approximately 12-15 months of age (to be administered by the volunteers' personal pediatrician, not as a study vaccine). They will then come for a study visit to collect blood 60 days later.
Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.
- Being tested
- Fluzone®, FluMist®
- Keywords
- Inactivated, influenza vaccine quadrivalent, Live, attenuated influenza vaccine quadrivalent, Young children, Identical 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®Biological
Also called IIV4
Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
FluMist®Biological
Also called LAIV4
FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| MZ twins 2-5 yo | Experimental | Monozygotic twins, 2-5 yo (annual return): In 2014-2015, individual twin participants will be given FluMist® a live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0, 7 and 60 post-immunization. Vaccine naive children will receive two immunizations in the first year, 28 days apart then return annually for flu immunization. Blood samples will be obtained on Days 0, 7 and 60 post second-immunization. Beginning in 2015-2016, participants in this arm will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) as an intramuscular (IM) injection annually following Advisory Committee on Immunization Practices (ACIP) recommendation against LAIV4. Receives: Biological: Fluzone®; Biological: FluMist® |
| Non-twins 6 mo-10 yo | Experimental | Non-twins 6 mo-10 years (annual return): In 2014-2015, participants between 6-23 mo will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) IM then switch to FluMist® a live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally starting at age 24 months in annual follow-up. Participants aged 24 mo-8 yo will be given LAIV4 at enrollment and for annual follow-up. However, if LAIV4 is contraindicated, the child will continue with IIV4. Participants 9-10 yo will be given IIV4 annually. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0 and 60 post immunization. Vaccine naive children will get two doses of vaccine the first year then return annually for flu immunization and blood samples on Day 0 and 60 post second immunization. Beginning in 2015-2016, all participants in this arm will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) annually following ACIP recommendation against LAIV4. Receives: Biological: Fluzone®; Biological: FluMist® |
| Non-twins 6-12 mo Flu/MMRV Naïve | Experimental | Non-twins 6-12 mo Flu/MMRV Naïve (annual return): In 2014-2015, participants 6-12 mo who are flu and MMRV naïve will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) as an IM injection. In Year 1, participants will return for a second flu immunization at least 28 days later and for blood samples on Days 0 and 60 post-second immunization and on Day 60 post MMRV (to be given by primary care physician). In Years 2-5, participants will return annually for Fluzone® IIV4 flu immunization and for blood samples on Days 0 and 60 post-immunization. Receives: Biological: Fluzone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of antigen-specific T memory phenotype cells (TMP)
The percentage of cells with the various antigen-specific T memory phenotypes will be determined.
Measured: Day 0 to Day 60
Secondary outcomes (2)
T cell receptor (TCR) repertoire analysis deep phenotyping by mass cytometry (CyTOF)
The TCR repertoire encompasses the different sub-types of T-cell receptors of the immune system.
Measured: Day 0 to Day 60
Deep phenotyping by mass cytometry (CyTOF)
Deep phenotyping is the analysis of phenotypic abnormalities of the individual components of the phenotype.
Measured: Day 0 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start30 Sep 2014
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Grant, Stanford University
- Investigators
- Cornelia L Dekker, MD, Principal investigator, Stanford UniversityMark M Davis, PhD, Principal investigator, Stanford UniversityPhilip M Grant, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453801
- Sponsor's protocol ID
- SU-31256
- Other IDs
- U19AI057229-11
- Acronym
- SLVP030
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection
- ClinicalTrials.gov ID
- NCT03453801
- Acronym / sponsor ID
- SLVP030 / SU-31256
- Keywords
- Inactivated, influenza vaccine quadrivalent, Live, attenuated influenza vaccine quadrivalent, Young children, Identical twins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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.
The purpose of this study is provide a better understanding of the adaptive immune response to the licensed influenza vaccines in children.
Detailed description
This is a Phase I study of up to 100 healthy children, ages 6 months to 10 years of age, who will receive either Flumist® live, attenuated influenza virus vaccine, quadrivalent (LAIV4) or the current Fluzone® inactivated influenza vaccine, quadrivalent (IIV4). The volunteers will be enrolled into one of 3 Groups. Volunteers will return each year until 2018-2019 for annual flu immunizations and study visits. Questionnaires will be administered annually to record demographic characteristics, vaccination history, exposure to animals, day care and medically attended illness. There are no exclusions for gender, ethnicity or race.
Volunteers in the Non-twin Flu/MMRV naive group will also receive the measles, mumps, rubella and varicella (MMRV) vaccine at approximately 12-15 months of age (to be administered by the volunteers' personal pediatrician, not as a study vaccine). They will then come for a study visit to collect blood 60 days later.
Each twin is counted as a single participant. All reporting numbers reflect the number of participants, not the number of twin pairs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MZ twins 2-5 yo | Experimental | Biological: Fluzone®, Biological: FluMist®Monozygotic twins, 2-5 yo (annual return): In 2014-2015, individual twin participants will be given FluMist® a live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0, 7 and 60 post-immunization. Vaccine naive children will receive two immunizations in the first year, 28 days apart then return annually for flu immunization. Blood samples will be obtained on Days 0, 7 and 60 post second-immunization. Beginning in 2015-2016, participants in this arm will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) as an intramuscular (IM) injection annually following Advisory Committee on Immunization Practices (ACIP) recommendation against LAIV4. |
| Non-twins 6 mo-10 yo | Experimental | Biological: Fluzone®, Biological: FluMist®Non-twins 6 mo-10 years (annual return): In 2014-2015, participants between 6-23 mo will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) IM then switch to FluMist® a live, attenuated influenza vaccine quadrivalent (LAIV4) intranasally starting at age 24 months in annual follow-up. Participants aged 24 mo-8 yo will be given LAIV4 at enrollment and for annual follow-up. However, if LAIV4 is contraindicated, the child will continue with IIV4. Participants 9-10 yo will be given IIV4 annually. Vaccine non-naive participants will return annually for flu immunization and for blood samples on Days 0 and 60 post immunization. Vaccine naive children will get two doses of vaccine the first year then return annually for flu immunization and blood samples on Day 0 and 60 post second immunization. Beginning in 2015-2016, all participants in this arm will receive Fluzone® inactivated influenza vaccine quadrivalent (IIV4) annually following ACIP recommendation against LAIV4. |
| Non-twins 6-12 mo Flu/MMRV Naïve | Experimental | Biological: Fluzone®Non-twins 6-12 mo Flu/MMRV Naïve (annual return): In 2014-2015, participants 6-12 mo who are flu and MMRV naïve will be given Fluzone® inactivated influenza vaccine quadrivalent (IIV4) as an IM injection. In Year 1, participants will return for a second flu immunization at least 28 days later and for blood samples on Days 0 and 60 post-second immunization and on Day 60 post MMRV (to be given by primary care physician). In Years 2-5, participants will return annually for Fluzone® IIV4 flu immunization and for blood samples on Days 0 and 60 post-immunization. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Otherwise healthy non-twins 6 months - 10 years old, or 2-5 year old identical (MZ) twins.
- Willing to complete the informed consent process (including assent for minors 7 years old and above).
- Availability for follow-up for the planned duration of the study - annually until 2018-2019 influenza vaccination season
- Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
- Non-twin flu/MMRV naive group: Willing to have primary care physician immunize child with the MMRV vaccine and return for a study visit approximately 60 days later.
Key exclusion criteria (19 listed)
- Prior off-study vaccination with the current year's seasonal influenza vaccine.
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products, or to vaccine components
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
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®Also: IIV4Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM. | Biological | MZ twins 2-5 yo, Non-twins 6 mo-10 yo, Non-twins 6-12 mo Flu/MMRV Naïve |
| FluMist®Also: LAIV4FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray | Biological | MZ twins 2-5 yo, Non-twins 6 mo-10 yo |
Primary outcome
Frequency of antigen-specific T memory phenotype cells (TMP)
Time frame: Day 0 to Day 60
The percentage of cells with the various antigen-specific T memory phenotypes will be determined.
2 secondary outcomes
T cell receptor (TCR) repertoire analysis deep phenotyping by mass cytometry (CyTOF)
Time frame: Day 0 to Day 60
Deep phenotyping by mass cytometry (CyTOF)
Time frame: Day 0 to Day 60
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 13 Feb 2020.
- 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
Philip M Grant, MD 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 1 study testing Fluzone® and FluMist® in people with Influenza and Healthy, 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 5 inclusion and 19 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 13 Feb 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of antigen-specific T memory phenotype cells (TMP) (time frame: Day 0 to Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2020.