Phase 4
Completed N=104
Body and Social Behavior
Psychology, Social · Inflammation · Defeat, Social · Interaction, Social
Source: ClinicalTrials.gov NCT05654441 ↗
Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: IL-6 Levels 24 Hours After Vaccine — 0.40; 0.23 log pg/mL — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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
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. Informational only — not medical advice.