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

NCT ID: NCT03756246

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2021-05-31

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.

Conditions

Depression; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Influenza Vaccine

Intervention Type: BIOLOGICAL

The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.

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

Group Type: ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type: BIOLOGICAL

The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.

Interventions

Influenza Vaccine

The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.

Intervention Type: BIOLOGICAL

Other Intervention Names

flu shot; flu vaccine

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

Exclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marisa Toups

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Project Coordinator

Role: CONTACT

behavioral.immunology.lab@dellmed.utexas.edu

512-495-5595

Maria Toups, M.D.

Role: CONTACT

marisa.toups@austin.utexas.edu

512-494-4672

Facility Contacts

Project Coordinator

Role: primary

behavioral.immunology.lab@dellmed.utexas.edu

512-495-5595

Alyssa Marron

Role: backup

alyssa.marron@austin.utexas.edu

512-495-5595

Other Identifiers

2018030078

Identifier Type: -

Identifier Source: org_study_id