Flu
Conditions
Keywords
influenza, flu, vaccine, vaccination, immune response, FluShield, FluMist, PET-CT, Healthy Volunteers
Brief summary
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.
Interventions
BIOLOGICALFluShield
Flu vaccine
BIOLOGICALFluShield - same arm
Flu vaccine
BIOLOGICALFluShield - opposite arm
Flu vaccine
PROCEDUREBlood Draws
50 cc of heparinized blood and 10 cc of serum at study entry and at 10-12 week post vaccination
PROCEDUREFDG PET-CT Scan
PET scan
GENETICCytokine Profiling
Blood draw for Cytokine Profiling Draw at 2,4 and 6 weeks post vaccination
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Hackensack Meridian Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET Scan AB Response | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine FluShield, FluMist Group I - Previous influenza positivity A or B within the past 5 years | 0 |
| Cytokine Profiling FluShield, FluMist Group II - History of FluMist vaccination within the past 2 years | 0 |
| Unilateral TIV Injections FluShield Group III a - History of TIV vaccination, any number of times, but only in a single (e.g., non-dominant) arm. 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). | 0 |
| Opposite Arm FluShield Group IIIb - Within one month of screening and baseline blood draws for PBMCs and Ab titers, individuals will receive FluShield injections. The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb). | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study was not completed, no data | 9 | 9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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.
Time frame: 4-7 days
Population: This study was not completed as planned, and data collected is not available despite all efforts as the PI has left the institution. Additionally, no manuscript, or study report was developed and therefore no data available to confirm the validity of or address the comments in relation to the previously entered results information.