Trial Outcomes & Findings for The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response (NCT NCT02642237)

NCT ID: NCT02642237

Last Updated: 2019-05-14

Results Overview

Interferon gamma-induced protein 10 is a marker of viral-induced inflammation. Higher levels indicate a more pronounced inflammatory response upon a viral infection.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 35 days after FLuenz inoculation
• Results posted on: 2019-05-14

Participant Flow

Participant milestones

Measure	LPS-Fluenz Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz LPS	Placebo-Fluenz Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz placebo
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response

Baseline characteristics by cohort

Measure	LPS-Fluenz n=15 Participants Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz LPS	Placebo-Fluenz n=15 Participants Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz placebo	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 35 days after FLuenz inoculation

Interferon gamma-induced protein 10 is a marker of viral-induced inflammation. Higher levels indicate a more pronounced inflammatory response upon a viral infection.

Outcome measures

Measure	LPS-Fluenz n=15 Participants Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz LPS	Placebo-Fluenz n=15 Participants Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin Fluenz: intranasal inoculation with Fluenz placebo
Peak Levels of Interferon Gamma-induced Protein 10 (IP-10) in Nasal Wash Fluid	2000 pg/mL Interval 900.0 to 3000.0	1900 pg/mL Interval 900.0 to 2800.0

Adverse Events

LPS-Fluenz

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo-Fluenz

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

Matthijs Kox

Radboud university medical centre

Phone: +31243653881

Email: matthijs.kox@radboudumc.nl

Results disclosure agreements

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