Cognitive, Emotional, and Neural Responses to Acute Inflammation

NCT03294564 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 14-13204K01MH109871
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a pilot study to examine the effects of acute inflammation on cognition and emotion in healthy participants using a between-subjects, randomized, double-blind design.

Conditions

Healthy

Keywords

Inflammation; Threat sensitivity; Reward sensitivity

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers elicited by the typhoid vaccine

  Participants will receive a vaccine or placebo and investigators will examine inflammation levels during three different time points via blood draws

  5-7 hours

Secondary Outcomes (2)

• Threat sensitivity between groups

  1-3 hours

• Reward sensitivity between groups

  1-2 hours

Study Arms (2)

Typhoid Vi Polysaccharide Vaccine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Patients will receive one intramuscular 0.5 mL injection of saline placebo.

Biological: Placebo

Interventions

Typhoid Vi Polysaccharide Vaccine 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.

Typhoid Vi Polysaccharide Vaccine

Placebo BIOLOGICAL

The placebo injection will consist of 0.5mL of saline.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals (free of chronic illness or lifetime history of psychiatric disorder)
• Non-smokers

You may not qualify if:

• Lifetime history of an psychiatric disorder with psychotic features, bipolar disorder, obsessive-compulsive disorder, alcohol or substance dependence, or a history of alcohol or substance abuse within the past 2 years.
• Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months, or has current diagnosis of PTSD.
• Diagnosis of sleep apnea, neurological disorder, systemic illness affective central nervous system function, and/or anemia.
• Any suicidal or homicidal ideation within the past year.
• Subjects currently receiving selective serotonin reuptake inhibitors (SSRIs), benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, any antidepressant medication including trazodone, or any psychotropic medication.
• Termination of SSRIs, benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, any antidepressant medication including trazodone in the last month, or plans to start these medications during the course of the study.
• Contraindications to fMRI, including severe claustrophobia and presence of ferromagnetic objects in the body that would interfere with magnetic resonance examination and/or cause a safety risk (e.g., pace makers, implanted stimulators, pumps, extensive dental work, upper body tattoos).
• Contraindications to typhoid vaccine, which include acute febrile illness within the past two weeks, disorders characterized by a deficiency to ability to mount a humoral or cell-mediated immune response, use of anti-malarial medications in the past six months, antibiotics in past three months, a history of hypersensitivity to typhoid vaccine or any other vaccine, pervious immunization with whole-cell typhoid or live, oral typhoid vaccines, vaccination with the polysaccharide version of the typhoid vaccine within the past 3 years.
• Conditions or use of substances that may be associated with inflammation, including drugs that affect the immune system.
• Any chronic medical illness.
• Having a body mass index (BMI) over 30.
• Individuals who work the night shift

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aoife S O'Donovan, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

US (2)