Phase 4 N=104 Randomized Double-blind Basic Science

Body and Social Behavior

Psychology, Social · Inflammation · Defeat, Social · Interaction, Social

Bottom Line

View on ClinicalTrials.gov: NCT05654441 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: IL-6 Levels 24 Hours After Vaccine — 0.40; 0.23 log pg/mL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Influenza vaccine (Biological); Placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY IL-6 Levels 24 Hours After Vaccine	0.40; 0.23	<0.001 sig
PRIMARY IL-10 Levels 24 Hours After Vaccine	0.50; 0.36	<0.001 sig
PRIMARY TNF-alpha Levels 24 Hours After Vaccine	0.93; 0.88	0.007 sig
PRIMARY IFN-gamma Levels 24 Hours After Vaccine	0.44; -0.14	<0.001 sig
SECONDARY Sickness Symptom Scores	7.00; 7.12	0.886
SECONDARY High Arousal Negative Affect Scores	8.67; 7.64	.666
SECONDARY Low Arousal Negative Affect Scores	20.35; 18.19	.522
SECONDARY High Arousal Positive Affect Scores	37.30; 33.99	.438
SECONDARY Low Arousal Positive Affect Scores	48.71; 43.50	.181
SECONDARY Sleep Quality Scores	5.13; 5.13	.833
SECONDARY Social Disconnection Scores	2.34; 2.42	.455

Summary

This randomized, double-blind, placebo-controlled study of the influenza vaccine will shed important light on how the immune system responds to different positive and negative social experiences. Building on the nuanced animal literature showing that, while animals exposed to an inflammatory challenge show reductions in social exploration consistent with the sickness behavior of social withdrawal, they actually show increases in social engagement behavior during interactions with a cage mate or pair-bonded animal. The present study will examine if a mild inflammatory challenge (receipt of the influenza vaccine) leads to change in actual social behavior in interactions, specifically toward a stranger and separately, toward a close friend. This study will also build on foundational animal research showing that an inflammatory challenge leads to social defeat behaviors in animals.

Eligibility Criteria

Inclusion Criteria

18-35 years old
Have a same-gender friend willing to participate in the second study session

Exclusion Criteria

Are not a student
Have already received the annual influenza vaccine or had the flu this season
Report current illness/sickness symptoms, including upper respiratory symptoms
Report any major medical conditions (e.g., diabetes, asthma)
Use mood or immune altering medications (e.g., anti-depressants)
Current regular nicotine/tobacco use (i.e., daily use of cigarettes or e-cigarettes)
Have an allergy to eggs
Have had COVID-19 in past two weeks
Current or history of depression or anxiety
Have had Guillain-Barre Syndrome
Are allergic to vaccine or ingredients present in vaccine
Have had an adverse reaction to a blood draw, including to needles or sight or blood
Weigh less than 110 pounds
Are unwilling to be video/audio recorded during the social interaction tasks
Are unwilling to be unmasked during the social interaction tasks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05654441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.