NCT02628054

Brief Summary

Research studies have found a relationship between the immune system (how the body reacts to an infection) and the development of depression. As it is still unclear how they might be linked the investigators will use a typhoid vaccination to activate the body's immune system and will measure the response by looking at changes in sleep patterns.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

November 19, 2015

Last Update Submit

May 8, 2018

Conditions

Typhoid Vaccine on Sleep

Keywords

PSGTyphoid VaccineDepressionInflammation

Outcome Measures

Primary Outcomes (1)

  • Acute (night 1) differences in sleep architecture, measured using polysomnography, following afternoon administration of the typhoid vaccine compared to placebo (saline) injection

    19 hours

Secondary Outcomes (6)

  • Changes in Interleukin-6 (IL-6) levels following typhoid vaccine compared to placebo (saline) injection

    2 hours

  • Change in PANAS subjective mood rating scores, following afternoon administration of the typhoid vaccine compared to placebo (saline) injection

    1 hour, 2 hours, 3 hours, 4 hours

  • Change in VAS Bond and Lader subjective mood rating scores, following afternoon administration of the typhoid vaccine compared to placebo (saline) injection

    1 hour, 2 hours, 3 hours, 4 hours

  • Change in adverse effects scores, following afternoon administration of the typhoid vaccine compared to placebo (saline) injection

    1 hour, 2 hours, 3 hours, 4 hours and 19 hours

  • Change in LSEQ subjective rating scores, following afternoon administration of the typhoid vaccine compared to placebo (saline) injection

    19 hours

  • +1 more secondary outcomes

Study Arms (2)

Typhoid Vaccine

ACTIVE COMPARATOR

Typhoid vaccination in single 0.5mL injections into the non-dominant deltoid muscle in the arm

Biological: Typhoid Vaccine

Placebo

PLACEBO COMPARATOR

A single 0.5mL injection of 0.9% sodium chloride saline solution into the non-dominant deltoid muscle in the arm

Biological: Placebo

Interventions

Typhoid VaccineBIOLOGICAL

Typhoid Vaccine injection given 7 days apart

Also known as: Typhim Vi®
Typhoid Vaccine
PlaceboBIOLOGICAL

Saline injection given 7 days apart

Also known as: 0.9% sodium chloride saline solution
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Healthy adults, Male or Female, aged 18 to 40 years.
  • Not currently taking any medications (except the contraceptive pill).
  • Good sleeper determined by self-report and sleep screening interview

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Any current or previous Axis 1 psychiatric disorder on DSM-5
  • Diagnosis of current sleep disorder
  • Any significant current medical condition likely to interfere with the conduct of the study or analysis of data
  • Typhoid vaccination within the last 3 years
  • Any vaccination within the last 6 months
  • History of allergies to drugs or vaccines or any component of the typhoid vaccine
  • Congenital or acquired immune deficiency (including participants receiving immunosuppressive or antimitotic drugs)
  • Bleeding disorder, e.g. haemophilia or thrombocytopenia
  • Current or recent physical illness or infection within previous 2 weeks
  • Steroidal or non-steroidal anti-inflammatory medication within preceding 2 weeks, including aspirin and ibuprofen
  • Current substance misuse
  • Child bearing age and not using reliable form of contraception
  • Has taken part in a psychological or medical experiment involving taking any kinds of drugs within the last 6 weeks
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Anisman H. Cascading effects of stressors and inflammatory immune system activation: implications for major depressive disorder. J Psychiatry Neurosci. 2009 Jan;34(1):4-20.

    PMID: 19125209BACKGROUND

  • Brydon L, Harrison NA, Walker C, Steptoe A, Critchley HD. Peripheral inflammation is associated with altered substantia nigra activity and psychomotor slowing in humans. Biol Psychiatry. 2008 Jun 1;63(11):1022-9. doi: 10.1016/j.biopsych.2007.12.007. Epub 2008 Feb 1.

    PMID: 18242584BACKGROUND

  • Brydon L, Walker C, Wawrzyniak A, Whitehead D, Okamura H, Yajima J, Tsuda A, Steptoe A. Synergistic effects of psychological and immune stressors on inflammatory cytokine and sickness responses in humans. Brain Behav Immun. 2009 Feb;23(2):217-24. doi: 10.1016/j.bbi.2008.09.007. Epub 2008 Sep 20.

    PMID: 18835437BACKGROUND

  • Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness and depression: when the immune system subjugates the brain. Nat Rev Neurosci. 2008 Jan;9(1):46-56. doi: 10.1038/nrn2297.

    PMID: 18073775BACKGROUND

  • Felger JC, Lotrich FE. Inflammatory cytokines in depression: neurobiological mechanisms and therapeutic implications. Neuroscience. 2013 Aug 29;246:199-229. doi: 10.1016/j.neuroscience.2013.04.060. Epub 2013 May 3.

    PMID: 23644052BACKGROUND

  • Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Critchley HD. Inflammation causes mood changes through alterations in subgenual cingulate activity and mesolimbic connectivity. Biol Psychiatry. 2009 Sep 1;66(5):407-14. doi: 10.1016/j.biopsych.2009.03.015. Epub 2009 May 7.

    PMID: 19423079BACKGROUND

  • Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Dolan RJ, Critchley HD. Neural origins of human sickness in interoceptive responses to inflammation. Biol Psychiatry. 2009 Sep 1;66(5):415-22. doi: 10.1016/j.biopsych.2009.03.007. Epub 2009 May 1.

    PMID: 19409533BACKGROUND

  • Miller AH, Maletic V, Raison CL. Inflammation and its discontents: the role of cytokines in the pathophysiology of major depression. Biol Psychiatry. 2009 May 1;65(9):732-41. doi: 10.1016/j.biopsych.2008.11.029. Epub 2009 Jan 15.

    PMID: 19150053BACKGROUND

  • Motivala SJ, Sarfatti A, Olmos L, Irwin MR. Inflammatory markers and sleep disturbance in major depression. Psychosom Med. 2005 Mar-Apr;67(2):187-94. doi: 10.1097/01.psy.0000149259.72488.09.

    PMID: 15784782BACKGROUND

  • Raison CL, Borisov AS, Broadwell SD, Capuron L, Woolwine BJ, Jacobson IM, Nemeroff CB, Miller AH. Depression during pegylated interferon-alpha plus ribavirin therapy: prevalence and prediction. J Clin Psychiatry. 2005 Jan;66(1):41-8. doi: 10.4088/jcp.v66n0106.

    PMID: 15669887BACKGROUND

  • Raison CL, Capuron L, Miller AH. Cytokines sing the blues: inflammation and the pathogenesis of depression. Trends Immunol. 2006 Jan;27(1):24-31. doi: 10.1016/j.it.2005.11.006. Epub 2005 Nov 28.

    PMID: 16316783BACKGROUND

  • Wright CE, Strike PC, Brydon L, Steptoe A. Acute inflammation and negative mood: mediation by cytokine activation. Brain Behav Immun. 2005 Jul;19(4):345-50. doi: 10.1016/j.bbi.2004.10.003. Epub 2004 Dec 8.

    PMID: 15944074BACKGROUND

  • Sharpley AL, Cooper CM, Williams C, Godlewska BR, Cowen PJ. Effects of typhoid vaccine on inflammation and sleep in healthy participants: a double-blind, placebo-controlled, crossover study. Psychopharmacology (Berl). 2016 Sep;233(18):3429-35. doi: 10.1007/s00213-016-4381-z. Epub 2016 Aug 9.

    PMID: 27503474DERIVED

MeSH Terms

Conditions

DepressionInflammation

Interventions

Typhoid-Paratyphoid VaccinesVi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmonella VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ann L Sharpley, BSc, PhD

    Psychopharmacology Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 11, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 14, 2018

Record last verified: 2018-05