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Humoral and Cellular Response in Shift Workers

Primary Purpose

Other Condition That May be a Focus of Clinical Attention

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Vaccination against hepatitis A
No Intervention
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Other Condition That May be a Focus of Clinical Attention focused on measuring Shift work, Hepatitis A vaccination, humoral response, cellular response

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • shift workers
  • naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL

Exclusion Criteria:

  • smokers
  • individuals with complaints and/or sleep disorders
  • acute or chronic disease
  • use of medication during the study period.
  • acute illnesses

Sites / Locations

  • Centro de Estudos em Psicobiologia e Exercicio _ CEPE
  • Centro de Estudos em Psicobiologia e Exercicio - CEPE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shiftwork

Arm Description

The comparison will consider nightworkers versus dayworkers.

Outcomes

Primary Outcome Measures

Antibodies against hepatitis A virus (anti-HAV)
Change in antibodies against hepatitis A virus (anti-HAV) production

Secondary Outcome Measures

Intracellular cytokines
Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels
Catecholamines
Change in cathecolamines levels
Prolactin
Change in prolactin levels
Growth hormone
Change in growth hormone levels
Cortisol
Change in cortisol levels
Sleep disorders
Assessment of sleep disorders

Full Information

First Posted
February 2, 2012
Last Updated
January 9, 2018
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01528280
Brief Title
Humoral and Cellular Response in Shift Workers
Official Title
Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to access whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment.
Detailed Description
Sleep regulates immune functions. In this sense, we asked whether shift workers (morning, afternoon or night) vaccinated against hepatitis A would have some humoral and cellular response impairment. Men (18 to 55 years) will be recruited through different forms of media (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected to assess the humoral response in the experimental groups. The hormones prolactin, growth hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations in culture will be conducted to assess the cellular response profile against the vaccination through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Condition That May be a Focus of Clinical Attention
Keywords
Shift work, Hepatitis A vaccination, humoral response, cellular response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shiftwork
Arm Type
Experimental
Arm Description
The comparison will consider nightworkers versus dayworkers.
Intervention Type
Biological
Intervention Name(s)
Vaccination against hepatitis A
Intervention Description
Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
Antibodies against hepatitis A virus (anti-HAV)
Description
Change in antibodies against hepatitis A virus (anti-HAV) production
Time Frame
Baseline, 30 days, 60 days and 90 days
Secondary Outcome Measure Information:
Title
Intracellular cytokines
Description
Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels
Time Frame
Baseline, 30 days, 60 days and 90 days
Title
Catecholamines
Description
Change in cathecolamines levels
Time Frame
Baseline, 30 days, 60 days and 90 days
Title
Prolactin
Description
Change in prolactin levels
Time Frame
Baseline, 30 days, 60 days and 90 days
Title
Growth hormone
Description
Change in growth hormone levels
Time Frame
Baseline, 30 days, 60 days and 90 days
Title
Cortisol
Description
Change in cortisol levels
Time Frame
Baseline, 30 days, 60 days and 90 days
Title
Sleep disorders
Description
Assessment of sleep disorders
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: shift workers naive immune status against hepatitis A confirmed by hepatitis A virus (HAV) antibodies levels below 5 mIU/mL Exclusion Criteria: smokers individuals with complaints and/or sleep disorders acute or chronic disease use of medication during the study period. acute illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Tulio Mello, Associate Professor
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francieli Silva Ruiz, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Maculano, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Centro de Estudos em Psicobiologia e Exercicio _ CEPE
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020050
Country
Brazil
Facility Name
Centro de Estudos em Psicobiologia e Exercicio - CEPE
City
Sao Paulo
ZIP/Postal Code
04020050
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.unifesp.br/dpsicobio/
Description
Psychobiology Department of Federal University of Sao Paulo
URL
http://www.fapesp.br/
Description
Fundação de Amparo à Pesquisa do Estado de São Paulo

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Humoral and Cellular Response in Shift Workers

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