NCT03756246

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine	The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.

Timeline

• Start date: 2019-06-10
• Primary completion: 2020-05-01
• Completion: 2021-05-01
• First posted: 2018-11-28
• Last updated: 2019-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study