Trial Outcomes & Findings for PET-CT Scans in Healthy Volunteers After Flu Vaccination (NCT NCT00769002)

NCT ID: NCT00769002

Last Updated: 2020-10-19

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 4-7 days
• Results posted on: 2020-10-19

Participant Flow

Participant milestones

Measure	PET-CT Scan Influenza Vaccine Response Previous influenza positivity FluShield, FluMist: Flu vaccine Previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination	Cytokine Profiling No previous influenza positivity FluShield, FluMist: Flu vaccine Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination
Overall Study STARTED	9	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Measure	PET-CT Scan Influenza Vaccine Response Previous influenza positivity FluShield, FluMist: Flu vaccine Previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination	Cytokine Profiling No previous influenza positivity FluShield, FluMist: Flu vaccine Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination Active Comparator: Cytokine Profiling FluShield, FluMist No previous influenza positivity Primary Outcome Measure: 1. Not Posted PET-CT Scan \[Time Frame: 4-7 days after flu vaccine\] Secondary Outcome Measures: 2. Not Posted Cytokine Profiling \[Time Frame: 2-6 weeks and 10-12 months post flu vaccination
Overall Study Study was not completed, no data	9	9

Baseline Characteristics

PET-CT Scans in Healthy Volunteers After Flu Vaccination

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Influenza Vaccine FluShield, FluMist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cytokine Profiling FluShield, FluMist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Schwartz

Hackensack University Medical Center

Phone: 551-996-2000

Email: DSchwartz@hackensackumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place