Psychology, SocialPhase 4BSBNCT05654441
Body and Social Behavior
A Phase 4 study testing Influenza vaccine in people with Psychology, Social and Inflammation, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychology, Social, Inflammation, Defeat, Social
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2022to 15 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- Have a same-gender friend willing to participate in the second study session
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical and Translation Research Center
Chapel Hill, North Carolina, 27514
Howell Hall
Chapel Hill, North Carolina, 27599
About this study
Official title: Low-grade Inflammatory Challenge and Social Behavior
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.
Read the detailed description
Psychologists have long appreciated that the mind can impact the body, and that bodily changes can influence the mind. Social psychologists in particular have conducted pioneering work on connections between the mind and body, showing both that social experiences elicit changes in numerous physiological systems and that physiological changes influence social cognition and behavior. Until recently, however, little attention has been paid to the connections between social experiences and the immune system. This is a critical gap knowledge, as seminal animal work shows that there are profound relationships between social experiences and immune system functioning that have yet to be fully explored in humans. Further, there are strong theoretical reasons to suspect that the immune system matters for social psychological processes even beyond times of sickness, though many of these connections are yet to be uncovered empirically in humans. Thus, to develop a comprehensive understanding of the mind-body connections that drive social behavior, researchers must integrate the immune system.
To address this critical gap in knowledge, the present study will examine the body-to-mind connection between the immune system and positive (i.e., interacting with a close other) and negative (i.e., social defeat) social experiences.
Why does the immune system matter for social behavior? There are good theoretical reasons why the immune system would be tightly interconnected to even normative, everyday social experiences beyond times of sickness. First, despite the common belief that the immune system only comes "online" in response to pathogens or physical injury, the immune system is in fact always active and fluctuates considerably even in the absence of an acute infection. Indeed, the immune system is responsive to both real and imagined situations that may signal increased probability of injury or infection. This includes everyday social experiences and situations of greater interest to social psychologists, from falling in love to being socially ostracized. Second, the brain is constantly monitoring the physiological state of the body and integrating this interoceptive information with signals from the broader environment to anticipate current and future metabolic demands and guide adaptive behavior. Thus, even relatively minor fluctuations in immune system activation beyond times of sickness can feed back to the brain to guide social cognition and behavior. In sum, there are strong theoretical reasons why everyday, normative social experiences may affect and be affected by immune system activation.
To date, social withdrawal is considered a hallmark "sickness behavior", based on both animal and human work showing that experimentally-induced increases in inflammation lead to less social exploration and greater feelings of social disconnection. However, other animal work suggests that the effects of inflammation on social behavior may be more nuanced than uniform social withdrawal, as some research shows that animals spend more time huddling with familiar cagemates, and form pair bonds more quickly when exposed to an inflammatory challenge. Further, recent work in the field of psychoneuroimmunology with humans replicates this, showing that an inflammatory challenge causes heightened (not diminished) neural responses to reminders of social connection. Yet to date, no known human work has examined if an inflammatory challenge causes changes in actual social behavior in humans, a critical next step in this line of research. Techniques from experimental social psychology are ideally-suited to address this next step, as social psychology has been at the cutting-edge of developing tools for eliciting and quantifying social behavior, particularly in the context of dyadic interactions that are likely to be important during an inflammatory challenge. This study will bring this important perspective to bear to further understanding of how immune system activation may cause changes in social behavior.
There is a storied history in psychoneuroimmunology (PNI) of using vaccines (e.g., influenza, typhoid) as a way to study immune system functioning. In vaccine trials, researchers typically examine how individual-differences in psychological processes (e.g., depressive symptoms, social connection) influence the effectiveness of the vaccine by examining the number of antibody titers produced following vaccination as a function of the individual-difference of interest. More recently, researchers have begun to use the influenza vaccine as a way to manipulate levels of inflammation, as the vaccine produces a small, but significant, increase in inflammatory markers (e.g., interleukin-6) in the 24-hours following vaccination administration. Prior work has examined the impact of vaccine-induced increases in inflammation on psychological processes such as mood and reward processing and shown that within-subject changes in inflammation in response to the influenza vaccine predict increases in daily negative affect and increases in reward responsivity. The present project will build on this prior work by adding a placebo-controlled (saline) condition, thus allowing researchers to determine if vaccine-induced changes in inflammation cause changes in social behavior. Using the influenza vaccine as an inflammatory challenge has numerous advantages over prior approaches: 1) It provides a public health service to the local community (i.e., given that vaccinations can prevent viral outbreaks) rather than making participants temporarily ill, as in the rhinovirus studies and endotoxin studies discussed previously; 2) The change in inflammation elicited by the vaccine is relatively small, thus mirroring more normative, day-to-day fluctuations in inflammation beyond times of sickness; and 3) Experimental procedures are less resource and cost-intensive, as almost every local pharmacy provides influenza vaccinations, and the cost is often covered by insurance and is relatively low (or free) for the uninsured. Given these advantages, the present study will use the influenza vaccine to examine if an experimental manipulation of inflammation causes changes in social behavior of interest to both social psychologists and psychoneuroimmunologists. In doing so, the study will advance a method that can be widely adopted by researchers to study how immune system activation feeds back to the brain to influence social experience.
- Conditions
- Psychology, Social, Inflammation, Defeat, Social, Interaction, Social
- Being tested
- Influenza vaccine, Placebo
- Medical subject headings
- Inflammation, Social Defeat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
0.5 mL single-dose injection
PlaceboBiological
Also called Saline Injection
0.5 mL single-dose injection with no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine | Experimental | Experimental group given influenza vaccine (Flulaval) Receives: Biological: Influenza vaccine |
| Sham Vaccine | Placebo comparator | The control group given a placebo (saline injection) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Levels 24 Hours After Vaccine
The investigators will examine levels of IL-6 measured in plasma 24-hours following the vaccine.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within approximately 24 hours of treatment
Secondary outcomes (7)
Sickness Symptom Scores
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.
Measured: within approximately 24 hours of treatment
High Arousal Negative Affect Scores
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.
Measured: within approximately 24 hours of treatment
Low Arousal Negative Affect Scores
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.
Measured: within approximately 24 hours of treatment
High Arousal Positive Affect Scores
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.
Measured: within approximately 24 hours of treatment
Low Arousal Positive Affect Scores
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.
Measured: within approximately 24 hours of treatment
Sleep Quality Scores
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.
Measured: within approximately 24 hours of treatment
Social Disconnection Scores
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.
Measured: within approximately 24 hours of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start17 Oct 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Psychology, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Keely Muscatell, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654441
- Sponsor's protocol ID
- 22-1024
- Other IDs
- 2047344
- Acronym
- BSB
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2022
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Barrett LF. The theory of constructed emotion: an active inference account of interoception and categorization. Soc Cogn Affect Neurosci. 2017 Jan 1;12(1):1-23. doi: 10.1093/scan/nsw154.
PubMed 27798257SCHACHTER S, SINGER JE. Cognitive, social, and physiological determinants of emotional state. Psychol Rev. 1962 Sep;69:379-99. doi: 10.1037/h0046234. No abstract available.
PubMed 14497895Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
PubMed 15122924Richeson JA, Shelton JN. Negotiating Interracial Interactions: Costs, Consequences, and Possibilities. Current Directions in Psychological Science. 2007;16(6):316-320. doi:10.1111/j.1467-8721.2007.00528.x
Siegel EH, Sands MK, Van den Noortgate W, Condon P, Chang Y, Dy J, Quigley KS, Barrett LF. Emotion fingerprints or emotion populations? A meta-analytic investigation of autonomic features of emotion categories. Psychol Bull. 2018 Apr;144(4):343-393. doi: 10.1037/bul0000128. Epub 2018 Feb 1.
PubMed 29389177Bartz JA, Zaki J, Bolger N, Ochsner KN. Social effects of oxytocin in humans: context and person matter. Trends Cogn Sci. 2011 Jul;15(7):301-9. doi: 10.1016/j.tics.2011.05.002. Epub 2011 Jun 21.
PubMed 21696997Storbeck J, Clore GL. Affective Arousal as Information: How Affective Arousal Influences Judgments, Learning, and Memory. Soc Personal Psychol Compass. 2008 Sep 1;2(5):1824-1843. doi: 10.1111/j.1751-9004.2008.00138.x.
PubMed 25067943Eisenberger NI, Moieni M, Inagaki TK, Muscatell KA, Irwin MR. In Sickness and in Health: The Co-Regulation of Inflammation and Social Behavior. Neuropsychopharmacology. 2017 Jan;42(1):242-253. doi: 10.1038/npp.2016.141. Epub 2016 Aug 2.
PubMed 27480575Gassen J, Hill SE. Why inflammation and the activities of the immune system matter for social and personality psychology (and not only for those who study health). Soc Personal Psychol Compass. May 2019:e12471. doi:10.1111/spc3.12471
Kemeny ME. Psychobiological responses to social threat: evolution of a psychological model in psychoneuroimmunology. Brain Behav Immun. 2009 Jan;23(1):1-9. doi: 10.1016/j.bbi.2008.08.008. Epub 2008 Sep 10.
PubMed 18809488Hennessy MB, Deak T, Schiml PA. Sociality and sickness: have cytokines evolved to serve social functions beyond times of pathogen exposure? Brain Behav Immun. 2014 Mar;37:15-20. doi: 10.1016/j.bbi.2013.10.021. Epub 2013 Oct 31.
PubMed 24184399Dhabhar FS, Malarkey WB, Neri E, McEwen BS. Stress-induced redistribution of immune cells--from barracks to boulevards to battlefields: a tale of three hormones--Curt Richter Award winner. Psychoneuroendocrinology. 2012 Sep;37(9):1345-68. doi: 10.1016/j.psyneuen.2012.05.008. Epub 2012 Jun 22.
PubMed 22727761Leschak CJ, Eisenberger NI. Two Distinct Immune Pathways Linking Social Relationships With Health: Inflammatory and Antiviral Processes. Psychosom Med. 2019 Oct;81(8):711-719. doi: 10.1097/PSY.0000000000000685.
PubMed 31600173Slavich GM, Irwin MR. From stress to inflammation and major depressive disorder: a social signal transduction theory of depression. Psychol Bull. 2014 May;140(3):774-815. doi: 10.1037/a0035302. Epub 2014 Jan 13.
PubMed 24417575Slavich GM, Cole SW. The Emerging Field of Human Social Genomics. Clin Psychol Sci. 2013 Jul;1(3):331-348. doi: 10.1177/2167702613478594.
PubMed 23853742
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-grade Inflammatory Challenge and Social Behavior
- ClinicalTrials.gov ID
- NCT05654441
- Acronym / sponsor ID
- BSB / 22-1024
- Conditions
- Psychology, Social, Inflammation, Defeat, Social, Interaction, Social
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psychologists have long appreciated that the mind can impact the body, and that bodily changes can influence the mind. Social psychologists in particular have conducted pioneering work on connections between the mind and body, showing both that social experiences elicit changes in numerous physiological systems and that physiological changes influence social cognition and behavior. Until recently, however, little attention has been paid to the connections between social experiences and the immune system. This is a critical gap knowledge, as seminal animal work shows that there are profound relationships between social experiences and immune system functioning that have yet to be fully explored in humans. Further, there are strong theoretical reasons to suspect that the immune system matters for social psychological processes even beyond times of sickness, though many of these connections are yet to be uncovered empirically in humans. Thus, to develop a comprehensive understanding of the mind-body connections that drive social behavior, researchers must integrate the immune system.
To address this critical gap in knowledge, the present study will examine the body-to-mind connection between the immune system and positive (i.e., interacting with a close other) and negative (i.e., social defeat) social experiences.
Why does the immune system matter for social behavior? There are good theoretical reasons why the immune system would be tightly interconnected to even normative, everyday social experiences beyond times of sickness. First, despite the common belief that the immune system only comes "online" in response to pathogens or physical injury, the immune system is in fact always active and fluctuates considerably even in the absence of an acute infection. Indeed, the immune system is responsive to both real and imagined situations that may signal increased probability of injury or infection. This includes everyday social experiences and situations of greater interest to social psychologists, from falling in love to being socially ostracized. Second, the brain is constantly monitoring the physiological state of the body and integrating this interoceptive information with signals from the broader environment to anticipate current and future metabolic demands and guide adaptive behavior. Thus, even relatively minor fluctuations in immune system activation beyond times of sickness can feed back to the brain to guide social cognition and behavior. In sum, there are strong theoretical reasons why everyday, normative social experiences may affect and be affected by immune system activation.
To date, social withdrawal is considered a hallmark "sickness behavior", based on both animal and human work showing that experimentally-induced increases in inflammation lead to less social exploration and greater feelings of social disconnection. However, other animal work suggests that the effects of inflammation on social behavior may be more nuanced than uniform social withdrawal, as some research shows that animals spend more time huddling with familiar cagemates, and form pair bonds more quickly when exposed to an inflammatory challenge. Further, recent work in the field of psychoneuroimmunology with humans replicates this, showing that an inflammatory challenge causes heightened (not diminished) neural responses to reminders of social connection. Yet to date, no known human work has examined if an inflammatory challenge causes changes in actual social behavior in humans, a critical next step in this line of research. Techniques from experimental social psychology are ideally-suited to address this next step, as social psychology has been at the cutting-edge of developing tools for eliciting and quantifying social behavior, particularly in the context of dyadic interactions that are likely to be important during an inflammatory challenge. This study will bring this important perspective to bear to further understanding of how immune system activation may cause changes in social behavior.
There is a storied history in psychoneuroimmunology (PNI) of using vaccines (e.g., influenza, typhoid) as a way to study immune system functioning. In vaccine trials, researchers typically examine how individual-differences in psychological processes (e.g., depressive symptoms, social connection) influence the effectiveness of the vaccine by examining the number of antibody titers produced following vaccination as a function of the individual-difference of interest. More recently, researchers have begun to use the influenza vaccine as a way to manipulate levels of inflammation, as the vaccine produces a small, but significant, increase in inflammatory markers (e.g., interleukin-6) in the 24-hours following vaccination administration. Prior work has examined the impact of vaccine-induced increases in inflammation on psychological processes such as mood and reward processing and shown that within-subject changes in inflammation in response to the influenza vaccine predict increases in daily negative affect and increases in reward responsivity. The present project will build on this prior work by adding a placebo-controlled (saline) condition, thus allowing researchers to determine if vaccine-induced changes in inflammation cause changes in social behavior. Using the influenza vaccine as an inflammatory challenge has numerous advantages over prior approaches: 1) It provides a public health service to the local community (i.e., given that vaccinations can prevent viral outbreaks) rather than making participants temporarily ill, as in the rhinovirus studies and endotoxin studies discussed previously; 2) The change in inflammation elicited by the vaccine is relatively small, thus mirroring more normative, day-to-day fluctuations in inflammation beyond times of sickness; and 3) Experimental procedures are less resource and cost-intensive, as almost every local pharmacy provides influenza vaccinations, and the cost is often covered by insurance and is relatively low (or free) for the uninsured. Given these advantages, the present study will use the influenza vaccine to examine if an experimental manipulation of inflammation causes changes in social behavior of interest to both social psychologists and psychoneuroimmunologists. In doing so, the study will advance a method that can be widely adopted by researchers to study how immune system activation feeds back to the brain to influence social experience.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine | Experimental | Biological: Influenza vaccineExperimental group given influenza vaccine (Flulaval) |
| Sham Vaccine | Placebo comparator | Biological: PlaceboThe control group given a placebo (saline injection) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 years old
- Have a same-gender friend willing to participate in the second study session
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccine0.5 mL single-dose injection | Biological | Influenza Vaccine |
| PlaceboAlso: Saline Injection0.5 mL single-dose injection with no therapeutic effect | Biological | Sham Vaccine |
Primary outcome
IL-6 Levels 24 Hours After Vaccine
Time frame: within approximately 24 hours of treatment
The investigators will examine levels of IL-6 measured in plasma 24-hours following the vaccine.
IL-10 Levels 24 Hours After Vaccine
Time frame: within approximately 24 hours of treatment
The investigators will examine levels of IL-10 measured in plasma 24-hours following the vaccine.
TNF-alpha Levels 24 Hours After Vaccine
Time frame: within approximately 24 hours of treatment
The investigators will examine levels of TNF-alpha measured in plasma 24-hours following the vaccine.
IFN-gamma Levels 24 Hours After Vaccine
Time frame: within approximately 24 hours of treatment
The investigators will examine levels of IFN-gamma measured in plasma 24-hours following the vaccine.
7 secondary outcomes
Sickness Symptom Scores
Time frame: within approximately 24 hours of treatment
High Arousal Negative Affect Scores
Time frame: within approximately 24 hours of treatment
Low Arousal Negative Affect Scores
Time frame: within approximately 24 hours of treatment
High Arousal Positive Affect Scores
Time frame: within approximately 24 hours of treatment
Low Arousal Positive Affect Scores
Time frame: within approximately 24 hours of treatment
Sleep Quality Scores
Time frame: within approximately 24 hours of treatment
Social Disconnection Scores
Time frame: within approximately 24 hours of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27798257Barrett LF. The theory of constructed emotion: an active inference account of interoception and categorization. Soc Cogn Affect Neurosci. 2017 Jan 1;12(1):1-23. doi: 10.1093/scan/nsw154.
- Background: PubMed 14497895SCHACHTER S, SINGER JE. Cognitive, social, and physiological determinants of emotional state. Psychol Rev. 1962 Sep;69:379-99. doi: 10.1037/h0046234. No abstract available.
- Background: PubMed 15122924Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
- BackgroundRicheson JA, Shelton JN. Negotiating Interracial Interactions: Costs, Consequences, and Possibilities. Current Directions in Psychological Science. 2007;16(6):316-320. doi:10.1111/j.1467-8721.2007.00528.x
- Background: PubMed 29389177Siegel EH, Sands MK, Van den Noortgate W, Condon P, Chang Y, Dy J, Quigley KS, Barrett LF. Emotion fingerprints or emotion populations? A meta-analytic investigation of autonomic features of emotion categories. Psychol Bull. 2018 Apr;144(4):343-393. doi: 10.1037/bul0000128. Epub 2018 Feb 1.
- Background: PubMed 21696997Bartz JA, Zaki J, Bolger N, Ochsner KN. Social effects of oxytocin in humans: context and person matter. Trends Cogn Sci. 2011 Jul;15(7):301-9. doi: 10.1016/j.tics.2011.05.002. Epub 2011 Jun 21.
- Background: PubMed 25067943Storbeck J, Clore GL. Affective Arousal as Information: How Affective Arousal Influences Judgments, Learning, and Memory. Soc Personal Psychol Compass. 2008 Sep 1;2(5):1824-1843. doi: 10.1111/j.1751-9004.2008.00138.x.
- Background: PubMed 27480575Eisenberger NI, Moieni M, Inagaki TK, Muscatell KA, Irwin MR. In Sickness and in Health: The Co-Regulation of Inflammation and Social Behavior. Neuropsychopharmacology. 2017 Jan;42(1):242-253. doi: 10.1038/npp.2016.141. Epub 2016 Aug 2.
- BackgroundGassen J, Hill SE. Why inflammation and the activities of the immune system matter for social and personality psychology (and not only for those who study health). Soc Personal Psychol Compass. May 2019:e12471. doi:10.1111/spc3.12471
- Background: PubMed 18809488Kemeny ME. Psychobiological responses to social threat: evolution of a psychological model in psychoneuroimmunology. Brain Behav Immun. 2009 Jan;23(1):1-9. doi: 10.1016/j.bbi.2008.08.008. Epub 2008 Sep 10.
- Background: PubMed 24184399Hennessy MB, Deak T, Schiml PA. Sociality and sickness: have cytokines evolved to serve social functions beyond times of pathogen exposure? Brain Behav Immun. 2014 Mar;37:15-20. doi: 10.1016/j.bbi.2013.10.021. Epub 2013 Oct 31.
- Background: PubMed 22727761Dhabhar FS, Malarkey WB, Neri E, McEwen BS. Stress-induced redistribution of immune cells--from barracks to boulevards to battlefields: a tale of three hormones--Curt Richter Award winner. Psychoneuroendocrinology. 2012 Sep;37(9):1345-68. doi: 10.1016/j.psyneuen.2012.05.008. Epub 2012 Jun 22.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keely Muscatell, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccine in people with Psychology, Social and Inflammation, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Levels 24 Hours After Vaccine (time frame: within approximately 24 hours of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654441, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.