Trial Outcomes & Findings for Body and Social Behavior (NCT NCT05654441)

NCT ID: NCT05654441

Last Updated: 2024-11-27

Results Overview

The investigators will examine levels of IL-6 measured in plasma 24-hours following the vaccine.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: within approximately 24 hours of treatment
• Results posted on: 2024-11-27

Participant Flow

Participant milestones

Measure	Influenza Vaccine Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Overall Study STARTED	52	52
Overall Study COMPLETED	52	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Body and Social Behavior

Baseline characteristics by cohort

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect	Total n=102 Participants Total of all reporting groups
Age, Continuous	20.46 years STANDARD_DEVIATION 1.69 • n=5 Participants	20.62 years STANDARD_DEVIATION 2.61 • n=7 Participants	20.54 years STANDARD_DEVIATION 2.18 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 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	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine levels of IL-6 measured in plasma 24-hours following the vaccine.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
IL-6 Levels 24 Hours After Vaccine	0.40 log pg/mL Standard Deviation 0.25	0.23 log pg/mL Standard Deviation 0.23

PRIMARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine levels of IL-10 measured in plasma 24-hours following the vaccine.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
IL-10 Levels 24 Hours After Vaccine	0.50 log pg/mL Standard Deviation 0.14	0.36 log pg/mL Standard Deviation 0.14

PRIMARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine levels of TNF-alpha measured in plasma 24-hours following the vaccine.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
TNF-alpha Levels 24 Hours After Vaccine	0.93 log pg/mL Standard Deviation 0.10	0.88 log pg/mL Standard Deviation 0.10

PRIMARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine levels of IFN-gamma measured in plasma 24-hours following the vaccine.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
IFN-gamma Levels 24 Hours After Vaccine	0.44 log pg/mL Standard Deviation 0.38	-0.14 log pg/mL Standard Deviation 0.21

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported sickness symptoms, as measured by the Sickness Questionnaire, as a function of vaccine condition. The 10-item Sickness Questionnaire includes Likert-type questions using a 4- point scale, the total range is 0-30 with higher scores indicating greater sickness symptoms.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Sickness Symptom Scores	7.00 score on a scale Standard Deviation 4.39	7.12 score on a scale Standard Deviation 4.12

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

he investigators will examine if there are differences in self-reported high arousal negative affect, as measured by a subscale of the Positive Affect-Negative Affect Schedule-X, as a function of vaccine condition. Participants indicated the extent to which they felt each of 11 high arousal negative emotions (i.e., "angry", "irritable", "nervous", "scared", "upset", "afraid", "ashamed", "distressed", "frustrated", "hostile", "jittery") on a 0 (not at all) -100 (extremely) sliding scale. Responses were then averaged with higher scores indicating greater high arousal negative affect.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
High Arousal Negative Affect Scores	8.67 score on a scale Standard Deviation 11.94	7.64 score on a scale Standard Deviation 11.95

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported low arousal negative affect, as measured by a subscale of the Positive Affect-Negative Affect Schedule-X, as a function of vaccine condition. Participants indicated the extent to which they felt each of four low arousal negative emotions (i.e., "bored", "guilty", "sad", "worn out") on a 0 (not at all) -100 (extremely) sliding scale. Responses were then averaged with higher scores indicating greater low arousal negative affect.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Low Arousal Negative Affect Scores	20.35 score on a scale Standard Deviation 16.02	18.19 score on a scale Standard Deviation 16.02

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported high arousal positive affect, as measured by a subscale of the Positive Affect-Negative Affect Schedule-X, as a function of vaccine condition. Participants indicated the extent to which they felt each of 10 high arousal positive emotions (i.e., "amused," "determined," "enthusiastic," "excited," "happy," "inspired", "proud," "strong," "active," "alert") on a 0 (not at all) -100 (extremely) sliding scale. Responses were then averaged with higher scores indicating greater high arousal positive affect.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
High Arousal Positive Affect Scores	37.30 score on a scale Standard Deviation 20.54	33.99 score on a scale Standard Deviation 22.12

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported low arousal positive affect, as measured by a subscale of the Positive Affect-Negative Affect Schedule-X, as a function of vaccine condition. Participants indicated the extent to which they felt each of 5 low arousal positive emotions (i.e., "attentive," "calm", "interested", "grateful", "relieved") on a 0 (not at all) -100 (extremely) sliding scale. Responses were then averaged with higher scores indicating greater low arousal positive affect.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Low Arousal Positive Affect Scores	48.71 score on a scale Standard Deviation 18.83	43.50 score on a scale Standard Deviation 20.06

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported sleep quality, as measured by five items adapted from the Brief Pittsburgh Sleep Quality Index, as a function of vaccine condition. The 5-item scale assess sleep duration, sleep quality, daytime dysfunction, sleep latency, and nighttime disturbances- each producing a score ranging from 0 to 3. These scores are then summed; the total range is 0-15 with higher scores indicating poorer sleep.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Sleep Quality Scores	5.13 score on a scale Standard Deviation 2.23	5.13 score on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: within approximately 24 hours of treatment

Population: Two Sham vaccine participants were excluded from analyses due to use of hydroxyzine before session.

The investigators will examine if there are differences in self-reported social disconnection, as measured by a subset of items utilized in prior research (Moieni et al., 2015), as a function of vaccine condition. The 10-item scale includes Likert-type questions using a 5- point scale ranging from 1 (Not at all) to 5 (Very much so) which are then averaged; the total range is 0-5 with higher scores indicating greater feelings of social disconnection.

Outcome measures

Measure	Influenza Vaccine n=52 Participants Experimental group given influenza vaccine (Flulaval) Influenza vaccine: 0.5 mL single-dose injection	Sham Vaccine n=50 Participants The control group given a placebo (saline injection) Placebo: 0.5 mL single-dose injection with no therapeutic effect
Social Disconnection Scores	2.34 score on a scale Standard Deviation .44	2.42 score on a scale Standard Deviation .65

Adverse Events

Influenza Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Vaccine

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

Keely Muscatell, PhD

University of North Carolina at Chapel Hill

Phone: 919-843-5467

Email: kmuscatell@unc.edu

Results disclosure agreements

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