Inflammatory Challenge and Fear

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06630884
Phase
PHASE1
Status
Recruiting
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Conditions

  • Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Typhoid VI Polysaccharide Vaccine Injectable Solution — BIOLOGICAL
    Salmonella typhi capsular polysaccharide vaccine (Typhoid Vi Polysaccharide Vaccine): Each dose of 0.5ml Salmonella typhi capsular polysaccharide vaccine (Sanofi Pasteur, SA) is formulated to contain 25μg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7±0.3), 4.150mg of sodium chloride, 0.065mg of disodium phosphate, 0.023mg of monosodium phosphate and 0.5ml of sterile water for injection. It is indicated for use by humans aged 2 years and older for protection against typhoid fever.
  • Saline Placebo (0.5mL injection) — OTHER
    The placebo injection will consist of 0.5mL of saline.

Study Details

The goal of this study is to learn if short-term changes in the immune system alter how we process information and experience fear. The main questions it aims to answer are: Do people who receive typhoid vaccine respond differently than those who receive a placebo saline vaccine? Do people who receive typhoid vaccine experience changes in how they think and feel? Participants will: Attend four appointments at the San Francisco VA Health Care System; Receive typhoid vaccine or placebo at one of the visits; Have their physiological responding measured while listening to sounds; Complete questionnaires and psychological tests.

Key Dates

Start date
Mar 28, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Polysaccharide typhoid vaccine
    Participants in this condition will receive an injection of 0.5ml Salmonella typhi capsular polysaccharide vaccine (Sanofi Pasteur, SA), which contains 25μg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7±0.3), 4.150mg of sodium chloride, 0.065mg of disodium phosphate, 0.023mg of monosodium phosphate and 0.5ml of sterile water for injection.
  • Placebo Comparator: Saline Placebo Arm
    Participants in this condition will receive and injection of 0.5ml of saline.

Primary Outcome Measure

Skin conductance response (SCR) [ Time Frame: SCR will be assessed at baseline, 4.5 hours, and one week after vaccine/placebo. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Health Care SystemSan FranciscoCalifornia94121-

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By research site
San Francisco VA Health Care System· San Francisco, CA

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