Body and Social Behavior

NCT05654441 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 22-10242047344
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (4)

• IL-6 Levels 24 Hours After Vaccine

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

  within approximately 24 hours of treatment

• IL-10 Levels 24 Hours After Vaccine

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

  within approximately 24 hours of treatment

• TNF-alpha Levels 24 Hours After Vaccine

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

  within approximately 24 hours of treatment

• IFN-gamma Levels 24 Hours After Vaccine

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

  within approximately 24 hours of treatment

Secondary Outcomes (7)

• Sickness Symptom Scores

  within approximately 24 hours of treatment

• High Arousal Negative Affect Scores

  within approximately 24 hours of treatment

• Low Arousal Negative Affect Scores

  within approximately 24 hours of treatment

• High Arousal Positive Affect Scores

  within approximately 24 hours of treatment

• Low Arousal Positive Affect Scores

  within approximately 24 hours of treatment

Study Arms (2)

Influenza Vaccine

EXPERIMENTAL

Experimental group given influenza vaccine (Flulaval)

Biological: Influenza vaccine

Sham Vaccine

PLACEBO COMPARATOR

The control group given a placebo (saline injection)

Biological: Placebo

Interventions

Influenza vaccine BIOLOGICAL

0.5 mL single-dose injection

Influenza Vaccine

Placebo BIOLOGICAL

0.5 mL single-dose injection with no therapeutic effect

Also known as: Saline Injection

Sham Vaccine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• U.S. National Science Foundation: collaborator

Study Sites (2)

Clinical and Translation Research Center

Chapel Hill, North Carolina, 27514, United States

Location

Howell Hall

Chapel Hill, North Carolina, 27599, United States

Location

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MeSH Terms

Conditions

Inflammation; Social Defeat

Interventions

Influenza Vaccines; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Keely Muscatell, PhD
• Organization: University of North Carolina at Chapel Hill

kmuscatell@unc.edu

919-843-5467

Study Officials

• Keely Muscatell, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: October 17, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning immediately following publication and ending 5 years after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (2)