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Body and Social Behavior

NCT05654441 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-11-27

Study results available
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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.

Conditions

  • Psychology, Social
  • Inflammation
  • Defeat, Social
  • Interaction, Social

Interventions

BIOLOGICAL

Influenza vaccine

0.5 mL single-dose injection

BIOLOGICAL

Placebo

0.5 mL single-dose injection with no therapeutic effect

Sponsors & Collaborators

  • U.S. National Science Foundation

    collaborator FED

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Keely Muscatell, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05654441 on ClinicalTrials.gov