Inflammation and Threat Sensitivity in PTSD (K01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03048929|
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Biological: Typhoid Vi Polysaccharide Vaccine Biological: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Inflammation on Neural Mechanisms of Threat Sensitivity in Posttraumatic Stress Disorder|
|Actual Study Start Date :||April 1, 2019|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||March 31, 2021|
Active Comparator: Typhoid Vi Polysaccharide Vaccine
Patients will receive one intramuscular 0.5 mL injection of Typhoid Vi Polysaccharide Vaccine containing 0.025 mg purified Vi polysaccharide.
Biological: Typhoid Vi Polysaccharide Vaccine
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.
Placebo Comparator: Placebo
Patients will receive one intramuscular 0.5 mL injection of saline placebo.
The placebo injection will consist of 0.5mL of saline.
- Neural activity to threat as assessed with functional magnetic resonance imaging [ Time Frame: Change from Visit 1 (baseline) to Visit 2 (within two weeks of baseline) ]On visits 1 (baseline) and 2 (post-vaccine or post-placebo administration), participants will perform computerized threat and reward tasks and investigators will measure and compare neural activity between groups (PTSD vs. control) and condition (endotoxin vs. placebo).
- Threat sensitivity [ Time Frame: Change from Visit 1 (baseline) to Visit 2 (within two weeks of baseline) ]Participants will perform computerized tasks designed to assess threat sensitivity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048929
|United States, California|
|San Francisco Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Aoife S O'Donovan, PhD||University of California, San Francisco|