FluPro00000226NCT00769002
PET-CT Scans in Healthy Volunteers After Flu Vaccination
A study testing FluShield, FluShield - same arm and FluShield - opposite arm in people with Flu, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu
- What is being tested?
- FluShield, FluShield - same arm and FluShield - opposite arm
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2011
- Phase
- Interventional
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women 21-55 years old.
- Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning
Who cannot join
- Diabetes
- Use of systemic steroids
- Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period
- Recent vaccination for other reasons (e.g., traveler's vaccines)
- Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack Univarsity medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Impact of Bilateral Priming on Response to Unilateral Flu Vaccination
This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.
Read the detailed description
Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.
This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).
Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.
Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.
- Conditions
- Flu
- Being tested
- FluShield, FluShield - same arm, FluShield - opposite arm, Blood Draws, FDG PET-CT Scan
- Keywords
- influenza, flu, vaccine, vaccination, immune response, FluShield, FluMist, PET-CT, Healthy Volunteers
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluShieldBiological
Flu vaccine
FluShield - same armBiological
Flu vaccine
FluShield - opposite armBiological
Flu vaccine
Blood DrawsProcedure or surgery
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination
FDG PET-CT ScanProcedure or surgery
PET scan
Cytokine ProfilingGenetic
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination
| Study group | Role | What they receive |
|---|---|---|
| Natural Infection | Active comparator | previously naturally infected Receives: Biological: FluShield; Procedure: Blood Draws; Procedure: FDG PET-CT Scan; Genetic: Cytokine Profiling |
| FluShield - influenza positivity | Active comparator | prior FluShield ipsilateral vaccinated Receives: Biological: FluShield; Biological: FluShield - same arm; Procedure: Blood Draws; Procedure: FDG PET-CT Scan; Genetic: Cytokine Profiling |
| FluShield - influenza positivity2 | Active comparator | prior FluShield contralateral vaccinated Receives: Biological: FluShield; Biological: FluShield - opposite arm; Procedure: Blood Draws; Procedure: FDG PET-CT Scan; Genetic: Cytokine Profiling |
| FluMist | Active comparator | prior FluMist vaccinated. Receives: Biological: FluShield; Procedure: Blood Draws; Procedure: FDG PET-CT Scan; Genetic: Cytokine Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET Scan AB Response
Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.
Measured: 4-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionAug 2011
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.
- Other trials for FluStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- David Schwartz, MD, PhD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769002
- Sponsor's protocol ID
- Pro00000226 - R21AI077102
- Other IDs
- 5R21AI077102-03
- Acronym
- Pro00000226
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2008
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bilateral Priming on Response to Unilateral Flu Vaccination
- ClinicalTrials.gov ID
- NCT00769002
- Acronym / sponsor ID
- Pro00000226 / Pro00000226 - R21AI077102
- Conditions
- Flu
- Keywords
- influenza, flu, vaccine, vaccination, immune response, FluShield, FluMist, PET-CT
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.
Detailed description
Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.
This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).
Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.
Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Natural Infection | Active comparator | Biological: FluShield, Procedure: Blood Draws, Procedure: FDG PET-CT Scan, Genetic: Cytokine Profilingpreviously naturally infected |
| FluShield - influenza positivity | Active comparator | Biological: FluShield, Biological: FluShield - same arm, Procedure: Blood Draws, Procedure: FDG PET-CT Scan, Genetic: Cytokine Profilingprior FluShield ipsilateral vaccinated |
| FluShield - influenza positivity2 | Active comparator | Biological: FluShield, Biological: FluShield - opposite arm, Procedure: Blood Draws, Procedure: FDG PET-CT Scan, Genetic: Cytokine Profilingprior FluShield contralateral vaccinated |
| FluMist | Active comparator | Biological: FluShield, Procedure: Blood Draws, Procedure: FDG PET-CT Scan, Genetic: Cytokine Profilingprior FluMist vaccinated. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women 21-55 years old.
- Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning
Key exclusion criteria (5 listed)
- Diabetes
- Use of systemic steroids
- Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period
- Recent vaccination for other reasons (e.g., traveler's vaccines)
- Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)
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 |
|---|---|---|
| FluShieldFlu vaccine | Biological | FluMist, FluShield - influenza positivity, FluShield - influenza positivity2, Natural Infection |
| FluShield - same armFlu vaccine | Biological | FluShield - influenza positivity |
| FluShield - opposite armFlu vaccine | Biological | FluShield - influenza positivity2 |
| Blood Draws50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination | Procedure or surgery | FluMist, FluShield - influenza positivity, FluShield - influenza positivity2, Natural Infection |
| FDG PET-CT ScanPET scan | Procedure or surgery | FluMist, FluShield - influenza positivity, FluShield - influenza positivity2, Natural Infection |
| Cytokine ProfilingBlood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination | Genetic | FluMist, FluShield - influenza positivity, FluShield - influenza positivity2, Natural Infection |
Primary outcome
PET Scan AB Response
Time frame: 4-7 days
Natural infection but not ipsilateral IM injection of FluShield, will prime the host for a specific activation of spleen and bilateral lymph nodes following a subsequent i.m injection of FluShield, as detected by PET-CT performed 4-7 days post- FluShield immunization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Schwartz, MD, PhD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluShield, FluShield - same arm and FluShield - opposite arm in people with Flu, run by Hackensack Meridian Health 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). 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?
PET Scan AB Response (time frame: 4-7 days). 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 19 Oct 2020.