Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06630884

Inflammatory Challenge and Fear Extinction: A Model to Enhance Understanding of Posttraumatic Stress Disorder

Led by University of California, San Francisco · Updated on 2025-12-15

288

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how short-term changes in the immune system affect how people process information and experience fear, particularly in those with and without posttraumatic stress disorder (PTSD). This study aims to understand whether receiving a typhoid vaccine leads to different responses compared to receiving a placebo saline injection, focusing on how inflammation might influence fear responses. The research also explores differences between men and women, given that PTSD affects women more frequently and inflammation may impact fear responses differently by sex. Participants will be randomly assigned to receive either a typhoid vaccine or a saline placebo injection. The vaccine contains purified components designed to provoke an immune response. The study involves initial physiological testing of fear responses, followed by vaccination or placebo administration three days later, and additional testing one week after the injection. Measures of inflammation will be collected at several points, including before and after the vaccine or placebo. During the study, participants will attend four appointments where their physiological reactions to sounds will be recorded, and they will complete questionnaires and psychological tests. Researchers will measure skin conductance responses, heart rate, and eyeblink activity at baseline, 4.5 hours, and one week after injection to assess fear responses. These assessments will help clarify the role of inflammation in fear processing and PTSD. The total study duration includes these multiple visits and follow-up measures to monitor safety and response changes.

CONDITIONS

Brief Title

Inflammatory Challenge and Fear

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 60 years old
  • Experienced trauma
  • Current PTSD or no history of PTSD
Not Eligible

You will not qualify if you...

  • Contraindications to typhoid vaccine
  • Conditions associated with inflammation
  • Pregnancy or plans to become pregnant in next three months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Assessment

Duration - 1 day

Participants undergo baseline physiological testing of fear responses and inflammatory markers before intervention.

1 visit (in-person)

Intervention Day

Duration - 1 day

Participants receive an injection of either the typhoid vaccine or saline placebo and undergo physiological testing including inflammatory marker measurements.

1 visit (in-person)

Follow-up Assessment

Duration - 1 day

Participants return one week later for physiological testing and measurement of inflammatory markers to assess effects of the intervention.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

San Francisco VA Health Care System

San Francisco, California, United States, 94121

Actively Recruiting

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Research Team

A

Aoife O'Donovan, PhD

M

Michael Srouji, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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