Humoral and Cellular Response in Shift Workers

January 9, 2018 updated by: Marco Tulio de Mello, Federal University of São Paulo

Vaccination Against Hepatitis A Virus in Shift Workers: Evaluation of the Humoral and Cellular Immune Response

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04020050
        • Centro de Estudos em Psicobiologia e Exercicio - CEPE
    • SP
      • Sao Paulo, SP, Brazil, 04020050
        • Centro de Estudos em Psicobiologia e Exercicio _ CEPE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shiftwork
The comparison will consider nightworkers versus dayworkers.
Other: No Intervention
No Intervention
Biological: Vaccination against hepatitis A
Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibodies against hepatitis A virus (anti-HAV)
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in antibodies against hepatitis A virus (anti-HAV) production
Baseline, 30 days, 60 days and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracellular cytokines
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in intracellular IL-4, IFN-γ, IL-2 e TNF-α cytokine levels
Baseline, 30 days, 60 days and 90 days
Catecholamines
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in cathecolamines levels
Baseline, 30 days, 60 days and 90 days
Prolactin
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in prolactin levels
Baseline, 30 days, 60 days and 90 days
Growth hormone
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in growth hormone levels
Baseline, 30 days, 60 days and 90 days
Cortisol
Time Frame: Baseline, 30 days, 60 days and 90 days
Change in cortisol levels
Baseline, 30 days, 60 days and 90 days
Sleep disorders
Time Frame: Baseline
Assessment of sleep disorders
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Director: Marco Tulio Mello, Associate Professor, Federal University of São Paulo
  • Study Chair: Francieli Silva Ruiz, PhD, Federal University of São Paulo
  • Study Chair: Andrea Maculano, PhD, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPE2012FRuiz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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