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Influenza Vaccine as a Novel Experimental Model of the Behavioral Immune Response in Depression

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ClinicalTrials.gov Identifier: NCT03756246
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE November 28, 2018
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
Positive and Negative Affect Schedules Score [ Time Frame: 1 Day ]
We will compute change in scores on the PANAS-x subscales between baseline and day 1. Self reported assessment that contains both positive and negative words and phrases that describe different feelings and emotions. Subjects read each item and mark the appropriate answer for how they feel right now as they fill out the form. Possible answers and the associated score are: (1) Not at all, (2) A little, (3) Moderately, (4) Quite a bit, (5) Extremely. To rate, responses to items in each scale are summed. The scales in the PANAS are listed below with the number of items in that scale in parentheses followed by the total range of the scale. General Dimensions Negative Affect (10) 10-50 General Dimensions of Positive Affect (10) 10-50 Negative Emotion Fear (6) 6-30 Hostility (6): 6-30 Guilt (6): 6-30 Sadness (5) 5- 25 Positive Emotion Joviality (8) 8-40 Self-Assurance (6) 6-30 Attentiveness (4) 4-20 Other Affective States Shyness (4) 4-20 Fatigue (4) 4-20 Serenity (3) 3-15
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03756246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • Change in Cytokine Concentration (pg/mL) [ Time Frame: 3 Days ]
    We will compute differences in cytokine (IFN- α, IFN-y, IL-6, IL1-β and TNF-α) values for each subject between baseline and day 1 and days 1 and 3. Using OLS regression we will compute regressions between hypothesis appropriate time points using baseline CRP, QIDS, PANAS score and BMI as covariates.
  • Difference in PGE4/LipoxinA4 Ratio [ Time Frame: 3 Days ]
    After determining the difference in the PGE4/LipoxinA4 ratio between days 1 and 3, we will perform a similar regression.
  • Tryptophan Metabolites [ Time Frame: 1 Day ]
    We will calculate difference between baseline and day 1 in the KYN/TRP and KYNA/QUIN ratios and us them in regression models as above, correcting for two tests.
  • HPA Axis [ Time Frame: 3 Days ]
    To test the hypothesis that ACTH/cortisol affects peak inflammatory cytokine levels in MDD, we will use similar OLS regression models including HPA-axis response as a covariate and examining its interaction with cytokines as the dependent variables.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 26, 2018)
Fold Change [ Time Frame: 28 Days ]
: Fold change from pre- to 28 days post-vaccine will be calculated for each of the three influenza strains targeted by the vaccine. Fold change > 4 to any one of the three strains will be considered "success." Proportion of successful vaccination will be compared between HC and MDD using a linear model adjusted for age and pre-vaccination titer, which have been shown to affect antibody response.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Influenza Vaccine as a Novel Experimental Model of the Behavioral Immune Response in Depression
Official Title  ICMJE Influenza Vaccine as a Novel Experimental Model of the Behavioral Immune Response in Depression
Brief Summary The purpose of this study is to determine differences between the immune responses in healthy and depressed people. Participants will receive the influenza vaccine and their responses will be monitored. This study will recruit 15 healthy and 60 depressed participants.
Detailed Description

The purpose of this study is to determine differences between the immune responses in healthy and depressed people. Specifically subjects are provided a mild immune stimulus, an influenza vaccine, and their responses are monitored. The goals are to determine whether patients with depression experience a temporary worsening of mood in response to the stimulus and whether this is associated with measurable differences in the cytokine response to the vaccine. Additionally, patients with depression may be less likely to mount a successful antibody response to vaccination as healthy people based on circumstantial evidence, and this study will assess whether this the case.

This study aims to recruit a sample of 15 healthy and 60 depressed participants. The 15 healthy participants will be age and gender matched to the first 15 depressed participants recruited. Three more sets of age and gender matched depressed subjects will be recruited. This will result in 15 sets of "quintuplets" (4 depressed and one healthy), that are matched by age and gender. The study consists of four visits. The first visit is the baseline assessment where participants will receive the influenza vaccine. Participants will then return 1, 3 and 28 days after receiving the vaccine to assess their responses.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Both healthy and depressed arms will receive the influenza vaccine.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Depression
  • Healthy
Intervention  ICMJE Biological: Influenza Vaccine
The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.
Other Names:
  • flu shot
  • flu vaccine
Study Arms  ICMJE
  • Experimental: Depression Subjects: Influenza Vaccine
    Subjects will receive a quadrivalent inactivated influenza vaccine, for the appropriate season/year of enrollment. The vaccine will be administered by the PI or similarly trained clinician, into the deltoid muscle as directed
    Intervention: Biological: Influenza Vaccine
  • Active Comparator: Healthy Subjects: Influenza Vaccine
    Subjects will receive a quadrivalent inactivated influenza vaccine, for the appropriate season/year of enrollment. The vaccine will be administered by the PI or similarly trained clinician, into the deltoid muscle as directed
    Intervention: Biological: Influenza Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria for all subjects

  • Adults age 18-60
  • Able to provide written informed consent directly, without use of a proxy
  • Able to speak and write in English sufficiently to undergo consent and to complete self reports

Inclusion Criteria for depressed subjects

  • Currently meets criteria for a Depressive Episode and a diagnosis of MDD according Mini International Neuropsychiatric Interview (MINI)
  • Depressive severity of ≥ 12 on the Quick Inventory of Depression Symptomatology, Clinician Rated (QIDS-C), corresponding to more than mild depression severity, but <21, indicating not severe

Inclusion Criteria for healthy Subjects

  • No lifetime Axis I diagnosis on the MINI
  • QIDS-SR score <6 indicating no depression
  • CRP at screening of <1mg/L.

Exclusion Criteria:

Exclusion Criteria for all subjects

  • Active, unstable, or serious medical illness (e.g. requiring urgent out-patient or higher level of care) as determined by history and lab examination at screening. For example, subjects with untreated cardiovascular disease (blood pressure above 140/80 on repeated measurements, history of cardiac event without medical follow up) or untreated diabetes (based on symptoms and elevated fasting blood sugar at screening) will be excluded.
  • Taking medications that have a significant effect on the immune system. This includes daily Non-steroidal Anti-inflammatory medications (NSAIDs). As needed NSAIDs will not be exclusionary but subjects will be asked to refrain from NSAID usage for 48 hours prior to the vaccination visit and through the day 3 visit.
  • Has received the influenza vaccine for the current season or within the last 12 months
  • Infection with fever or otherwise clinically significant in the last two weeks. Subjects with elevated white blood cell count at screening will also be excluded.
  • Current and within the last 3 months meeting criteria for tobacco use disorder.
  • Previous severe adverse event associated with IIV
  • History of allergy to any component of the IIV
  • History of Guillain-Barre Syndrome
  • Pregnancy
  • Otherwise judged unable to comply with study procedures or unsafe to participate by study clinician

Exclusion Criteria for Depressed Subjects

  • Life-time history of mania, hypomania, or psychosis on the MINI
  • Meets or has met criteria for substance abuse or dependence in the last 6 months (3 months for nicotine)
  • Meets or has met criteria for any eating disorder in the last 6 months
  • Baseline suicidal ideation above "passive" defined as thoughts of death or dying (e.g. wish for natural death) without thoughts of active methods (e.g. overdose) or intent to die, as determined using the Concise Health Risk Tracking Scale (CHRT) (assessment interval "the last week") and clinician interview.

No Exclusion Criteria for Healthy Subjects

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Project Coordinator 512-495-5595 behavioral.immunology.lab@dellmed.utexas.edu
Contact: Maria Toups, M.D. 512-494-4672 marisa.toups@austin.utexas.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03756246
Other Study ID Numbers  ICMJE 2018030078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Texas at Austin
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP